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Coronavirus Infections (808) Severe Acute Respiratory Syndrome (560) Infection (466) Pneumonia (365) Communicable Diseases (197) Respiratory Distress Syndrome, Adult (178) Acute Lung Injury (143) Respiratory Distress Syndrome, Newborn (143) (130) Syndrome (105) Virus Diseases (87) Pneumonia, Viral (82) Depression (65) Critical Illness (62) Anxiety Disorders (38) Respiratory Tract Infections (36) Cardiovascular Diseases (35) Emergencies (35) Stress, Psychological (31) Lung Injury (30) Neoplasms (30) Inflammation (29) Stress Disorders, Post-Traumatic (29) Wounds and Injuries (29) Hypoxia (28) Thrombosis (28) Diabetes Mellitus (26) Disease (25) Respiratory Tract Diseases (25) Stress Disorders, Traumatic (25) Depressive Disorder (24) Acute Kidney Injury (22) Disease Progression (22) Lung Diseases (22) Mental Disorders (21) Burnout, Psychological (19) Olfaction Disorders (19) Respiration Disorders (19) Thromboembolism (19) Hypertension (18) Embolism (16) Arthritis (15) Blood Coagulation 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Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Suicidal Ideation (1) Superinfection (1) Synovial Cyst (1) Tachycardia (1) Tachycardia, Ventricular (1) Tachypnea (1) Testicular Neoplasms (1) Thalassemia (1) Thoracic Diseases (1) Thrombocytopenia (1) Thrombophlebitis (1) Thrombotic Microangiopathies (1) Tobacco Use Disorder (1) Tonsillitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Trauma, Nervous System (1) Tuberculosis, Pulmonary (1) Urinary Tract Infections (1) Urogenital Neoplasms (1) Urologic Diseases (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Vascular Diseases (1) Ventricular Dysfunction, Right (1) Virus (1) Vitamin D Deficie (1) Voice Disorders (1) Vulvar Neoplasms (1) Waldenstrom Macroglobulinemia (1) Weight Gain (1) Weight Loss (1) Yellow Fever (1) beta-Thalassemia (1)

D011024: Pneumonia, Viral

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (167)


Name (Synonyms) Correlation
drug1846 Low molecular weight heparin Wiki 0.16
drug1995 Methylprednisolone Wiki 0.11
drug4071 ventilatory support with oxygen therapy Wiki 0.11
Name (Synonyms) Correlation
drug3479 Ultra-Low-dose radiotherapy Wiki 0.11
drug3811 hydroxychloroquine + azithromycin Wiki 0.11
drug3874 microcirculation recording Wiki 0.11
drug254 Antiviral Agents Wiki 0.11
drug1481 Hydroxychloroquine + placebo Wiki 0.11
drug2801 Respiratory Exercise Training Wiki 0.11
drug948 DB-001 Wiki 0.11
drug3781 favorable outcome Wiki 0.11
drug1961 Melphalan Wiki 0.11
drug3180 Sterile Normal Saline for Intravenous Use Wiki 0.11
drug1119 Echo-Doppler Wiki 0.11
drug1617 Information Wiki 0.11
drug1871 LungFit™ Wiki 0.11
drug3050 Simple chest tomography Wiki 0.11
drug2067 N-acetyl cysteine Wiki 0.11
drug1866 Lung Low Dose Radiation Wiki 0.11
drug3796 high flow nasal cannula device Wiki 0.11
drug3821 iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki 0.11
drug1479 Hydroxychloroquine + azithromycin + / - tocilizumab Wiki 0.11
drug2164 Nitric Oxide-Continuous and Sessions Wiki 0.11
drug1543 ID NOW vs. Accula Wiki 0.11
drug3263 TXA127 Wiki 0.11
drug2318 Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki 0.11
drug2187 No special intervention Wiki 0.11
drug58 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki 0.11
drug710 Centricyte 1000 Wiki 0.11
drug3048 Silymarin Wiki 0.11
drug896 CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test Wiki 0.11
drug2317 Oxygen supply Wiki 0.11
drug390 Bariatric procedures Wiki 0.11
drug2063 N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I Wiki 0.11
drug3181 Sterile Water for Injection Wiki 0.11
drug1456 Huaier Granule Wiki 0.11
drug1400 Helmet Continuous Positive Airway Pressure (CPAP) Wiki 0.11
drug3370 Tirofiban Injection Wiki 0.11
drug1311 Fondaparinux Wiki 0.11
drug2166 Nitric Oxide-Sessions Wiki 0.11
drug1220 Exposure (not intervention) - SARS-CoV-2 infection Wiki 0.11
drug3167 Standard treatment according to the Clinical protocols Wiki 0.11
drug1772 Let It Out (LIO)-C Wiki 0.11
drug3957 predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? Wiki 0.11
drug3512 VC Wiki 0.11
drug402 Bedside lung ultrasound Wiki 0.11
drug1859 Low-dose radiotherapy Wiki 0.11
drug2375 Pathogen-specific aAPC Wiki 0.11
drug3673 alveolar recruitment Wiki 0.11
drug2000 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.11
drug2159 Nitric Oxide Wiki 0.11
drug1642 Interferon-Alpha2B Wiki 0.11
drug1730 Kamada Anti-SARS-CoV-2 Wiki 0.11
drug875 Convalescent Serum Wiki 0.11
drug1415 High Flow Nasal Oxygen (HFNO) Wiki 0.11
drug953 DWJ1248 Wiki 0.11
drug3768 eculizumab Wiki 0.11
drug697 Carotid Artery Reactivity Testing Wiki 0.11
drug1814 Lopinavir-Ritonavir Drug Combination Wiki 0.11
drug3966 pulmonary anomalies 4 months after documented COVID-19 pneumonia Wiki 0.11
drug3672 alpha1-proteinase inhibitor Wiki 0.11
drug4063 unfractionated heparin Wiki 0.11
drug878 Convalescent anti-SARS-CoV-2 plasma Wiki 0.11
drug3932 oxyhydrogen Wiki 0.11
drug2162 Nitric Oxide delivered via LungFit™ system Wiki 0.11
drug589 COVID-19 Convalscent Plasma Wiki 0.11
drug2675 Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki 0.11
drug3024 Serology for Covid-19 Wiki 0.11
drug1720 Ivermectin and Doxycyline Wiki 0.11
drug3824 imaging, blood tests Wiki 0.11
drug1518 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 0.11
drug1562 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.11
drug541 CAStem Wiki 0.11
drug3473 UNIKINON (Chloroquine phosphate) 200mg tablets Wiki 0.11
drug3935 patients receiving nasal high flow Wiki 0.11
drug2091 NP-120 (Ifenprodil) Wiki 0.11
drug2694 Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index Wiki 0.11
drug126 AZD1656 Wiki 0.11
drug1622 Infusion placebo Wiki 0.11
drug26 150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki 0.11
drug755 Ciclesonide Inhalation Aerosol Wiki 0.11
drug1517 Hydroxychloroquine, Clindamycin Wiki 0.11
drug3082 Sofosbuvir and Ledipasvir Wiki 0.11
drug901 Corticosteroid injection Wiki 0.11
drug3799 home spirometry Wiki 0.11
drug2225 Nursing care to reduce anxiety, fear and loneliness Wiki 0.11
drug1867 Lung Ultrasound Wiki 0.11
drug3580 Vitamin E Wiki 0.11
drug2399 Pembrolizumab (MK-3475) Wiki 0.11
drug3383 Tocilizumab Injection [Actemra] Wiki 0.11
drug1956 Mefloquine + azithromycin + / - tocilizumab Wiki 0.11
drug1955 Mefloquine Wiki 0.11
drug2833 Ritonavir/lopinavir Wiki 0.11
drug2797 Repeat SARS-CoV-2 IgG antibodies at 45-65 days Wiki 0.11
drug1516 Hydroxychloroquine, Azithromycin Wiki 0.11
drug3926 oral polio vaccine + information Wiki 0.11
drug1619 Informed consent Wiki 0.11
drug191 Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Wiki 0.11
drug2446 Piperacillin/tazobactam Wiki 0.11
drug239 Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients Wiki 0.11
drug2377 Patient Education Wiki 0.11
drug1519 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 0.11
drug2704 Quetiapine Wiki 0.11
drug1352 Glycine Wiki 0.11
drug1780 Liberase Enzyme (Roche) Wiki 0.11
drug113 ATI-450 Wiki 0.11
drug145 Acetylsalicylic acid Wiki 0.11
drug567 COVI-AMG Wiki 0.11
drug1520 Hydroxychloroquine, Doxycycline Wiki 0.11
drug665 CYNK-001 Wiki 0.11
drug583 COVID-19 Androgen Sensitivity Test (CoVAST) Wiki 0.11
drug3530 Valproate Wiki 0.11
drug2168 Nivolumab Wiki 0.11
drug4033 standardized Lung Ultrasound (LUS) examination Wiki 0.11
drug2977 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.11
drug2135 Neutral writing control Wiki 0.11
drug217 Angiography scanner Wiki 0.11
drug1567 Ibudilast Wiki 0.11
drug2697 Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Wiki 0.11
drug1000 Dexamethasone Wiki 0.10
drug1869 Lung ultrasound Wiki 0.09
drug3063 SivoMixx (200 billion) Wiki 0.08
drug166 Aerobic Exercise Training Wiki 0.08
drug1168 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.08
drug143 Acebilustat Wiki 0.08
drug577 COVID Convalescent Plasma Wiki 0.08
drug2873 SARS-CoV-2 diagnostic rapid test Wiki 0.08
drug1312 Fostamatinib Wiki 0.08
drug1478 Hydroxychloroquine + azithromycin Wiki 0.08
drug1986 Metformin Wiki 0.08
drug900 Corticosteroid Wiki 0.08
drug2401 Pentoxifylline Wiki 0.08
drug3375 Tocilizumab Wiki 0.07
drug776 Clopidogrel Wiki 0.06
drug2751 Ravulizumab Wiki 0.06
drug857 Control group Wiki 0.06
drug3146 Standard of care Wiki 0.06
drug2616 Prone Positioning Wiki 0.06
drug2099 Naltrexone Wiki 0.06
drug125 AZD1222 Wiki 0.06
drug2448 Placebo Wiki 0.06
drug2153 Nitazoxanide Wiki 0.06
drug2584 Prednisone Wiki 0.06
drug3116 Standard Care Wiki 0.06
drug2313 Oxygen Wiki 0.06
drug1166 Enoxaparin Wiki 0.06
drug1936 Mavrilimumab Wiki 0.06
drug418 Best Supportive Care Wiki 0.06
drug2871 SARS-CoV-2 convalescent plasma Wiki 0.06
drug2858 SARS-CoV-2 Wiki 0.06
drug1958 Melatonin Wiki 0.06
drug333 Azithromycin Wiki 0.05
drug3469 UC-MSCs Wiki 0.05
drug2276 Online Survey Wiki 0.05
drug3810 hydroxychloroquine Wiki 0.05
drug671 Camostat Wiki 0.05
drug1472 Hydroxychloroquine Wiki 0.04
drug1822 Lopinavir/ritonavir Wiki 0.04
drug1824 Losartan Wiki 0.04
drug1492 Hydroxychloroquine Sulfate Wiki 0.03
drug791 Colchicine Wiki 0.03
drug3572 Vitamin C Wiki 0.03
drug3218 Survey Wiki 0.03
drug2174 No intervention Wiki 0.02
drug864 Convalescent Plasma Wiki 0.02
drug2782 Remdesivir Wiki 0.02
drug3138 Standard of Care Wiki 0.02

Correlated MeSH Terms (51)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.46
D008171 Lung Diseases, NIH 0.14
D045169 Severe Acute Respiratory Syndrome NIH 0.13
Name (Synonyms) Correlation
D017563 Lung Diseases, Interstitial NIH 0.12
D001261 Pulmonary Atelectasis NIH 0.11
D001469 Barotrauma NIH 0.11
D011649 Pulmonary Alveolar Proteinosis NIH 0.11
D004646 Emphysema NIH 0.11
D018410 Pneumonia, Bacterial NIH 0.11
D016769 Embolism and Thrombosis NIH 0.11
D001768 Blister NIH 0.11
D053717 Pneumonia, Ventilator-Associated NIH 0.11
D018352 Coronavirus Infections NIH 0.11
D053120 Respiratory Aspiration NIH 0.09
D012140 Respiratory Tract Diseases NIH 0.09
D008173 Lung Diseases, Obstructive NIH 0.08
D004617 Embolism NIH 0.08
D030341 Nidovirales Infections NIH 0.08
D054990 Idiopathic Pulmonary Fibrosis NIH 0.08
D012120 Respiration Disorders NIH 0.08
D009767 Obesity, Morbid NIH 0.06
D011251 Pregnancy Complications, Infectious NIH 0.06
D001987 Bronchiectasis NIH 0.06
D055370 Lung Injury NIH 0.06
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D007154 Immune System Diseases NIH 0.05
D003693 Delirium NIH 0.05
D003333 Coronaviridae Infections NIH 0.05
D014115 Toxemia NIH 0.05
D012127 Respiratory Distress Syndrome, Newborn NIH 0.05
D055371 Acute Lung Injury NIH 0.05
D009765 Obesity NIH 0.05
D013927 Thrombosis NIH 0.04
D003141 Communicable Diseases NIH 0.04
D018805 Sepsis NIH 0.04
D012327 RNA Virus Infections NIH 0.04
D011248 Pregnancy Complications NIH 0.04
D007239 Infection NIH 0.04
D004417 Dyspnea NIH 0.03
D007251 Influenza, Human NIH 0.03
D013577 Syndrome NIH 0.03
D020141 Hemostatic Disorders NIH 0.03
D011655 Pulmonary Embolism NIH 0.03
D011658 Pulmonary Fibrosis NIH 0.03
D001778 Blood Coagulation Disorders NIH 0.03
D016638 Critical Illness NIH 0.03
D014777 Virus Diseases NIH 0.02
D000860 Hypoxia NIH 0.02
D007249 Inflammation NIH 0.02
D002318 Cardiovascular Diseases NIH 0.02
D012141 Respiratory Tract Infections NIH 0.02

Correlated HPO Terms (17)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.45
HP:0002088 Abnormal lung morphology HPO 0.14
HP:0006515 Interstitial pneumonitis HPO 0.12
Name (Synonyms) Correlation
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.11
HP:0100750 Atelectasis HPO 0.11
HP:0006536 Pulmonary obstruction HPO 0.08
HP:0002110 Bronchiectasis HPO 0.06
HP:0001513 Obesity HPO 0.05
HP:0001907 Thromboembolism HPO 0.05
HP:0100806 Sepsis HPO 0.04
HP:0002098 Respiratory distress HPO 0.03
HP:0001928 Abnormality of coagulation HPO 0.03
HP:0002206 Pulmonary fibrosis HPO 0.03
HP:0002204 Pulmonary embolism HPO 0.03
HP:0012418 Hypoxemia HPO 0.02
HP:0011947 Respiratory tract infection HPO 0.02
HP:0001626 Abnormality of the cardiovascular system HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 82 clinical trials


1 A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia in Wuhan, China

Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.

NCT04260308
Conditions
  1. Virus; Pneumonia
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: GHQ-12(general health questionnaire-12): minimal score 0, maximal score 12, higher scores mean a better or worse outcome.

Measure: GHQ-12(general health questionnaire-12)

Time: 2 weeks

Secondary Outcomes

Description: IES-R(Impact of Event Scale-Revised):score range:0-88, the higher the worse

Measure: IES-R(Impact of Event Scale-Revised)

Time: 2 weeks
2 Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial

2019 new coronavirus (2019-nCoV) infected pneumonia, namely severe acute respiratory infection (SARI) has caused global concern and emergency. There is a lack of effective targeted antiviral drugs, and symptomatic supportive treatment is still the current main treatment for SARI. Vitamin C is significant to human body and plays a role in reducing inflammatory response and preventing common cold. In addtion, a few studies have shown that vitamin C deficiency is related to the increased risk and severity of influenza infections. We hypothize that Vitamin C infusion can help improve the prognosis of patients with SARI. Therefore, it is necessary to study the clinical efficacy and safety of vitamin C for the clinical management of SARI through randomized controlled trials during the current epidemic of SARI.

NCT04264533
Conditions
  1. Vitamin C
  2. Pneumonia, Viral
  3. Pneumonia, Ventilator-Associated
Interventions
  1. Drug: VC
  2. Drug: Sterile Water for Injection
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: days without ventilation support during 28 days after patients' enrollment

Measure: Ventilation-free days

Time: on the day 28 after enrollment

Secondary Outcomes

Description: wether the patient survives

Measure: 28-days mortality

Time: on the day 28 after enrollment

Description: days of the patients staying in the ICU

Measure: ICU length of stay

Time: on the day 28 after enrollment

Description: the rate of CPR

Measure: Demand for first aid measuments

Time: on the day 28 after enrollment

Description: days of using vasopressors

Measure: Vasopressor days

Time: on the day 28 after enrollment

Description: P O2/Fi O2 which reflects patients' respiratory function

Measure: Respiratory indexes

Time: on the day 10 and 28 after enrollment

Description: Ecmo or ventilator

Measure: Ventilator parameters

Time: on the day 10 and 28 after enrollment

Description: Acute Physiology and Chronic Health Evaluation

Measure: APACHE II scores

Time: on the day 10 after enrollment

Description: Sepsis-related Organ Failure Assessment

Measure: SOFA scores

Time: on the day 10 after enrollment
3 Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.

NCT04269525
Conditions
  1. Pneumonia, Viral
  2. Pneumonia, Ventilator-Associated
Interventions
  1. Biological: UC-MSCs
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)

Measure: Oxygenation index

Time: on the day 14 after enrollment

Secondary Outcomes

Description: whether the patient survives

Measure: 28 day mortality

Time: on the day 28 after enrollment

Description: days of the patients in hospital

Measure: Hospital stay

Time: up to 6 months

Description: whether or not the 2019-nCoV antibody is positive

Measure: 2019-nCoV antibody test

Time: on the day 7,14,28 after enrollment

Description: whether or not the 2019-nCoV nucleic acid test is positive

Measure: 2019-nCoV nucleic acid test

Time: on the day 7,14,28 after enrollment

Description: whether lung imaging examinations show the improvement of the pneumonia

Measure: Improvement of lung imaging examinations

Time: on the day 7,14,28 after enrollment

Description: counts of white blood cell in a litre of blood

Measure: White blood cell count

Time: on the day 7,14,28 after enrollment

Description: counts of lymphocyte in a litre (L) of blood

Measure: Lymphocyte count

Time: on the day 7,14,28 after enrollment

Description: procalcitonin in microgram(ug)/L

Measure: Procalcitonin

Time: on the day 7,14,28 after enrollment

Description: IL-2 in picogram(pg)/millilitre(mL)

Measure: interleukin(IL)-2

Time: on the day 7,14,28 after enrollment

Description: IL-4 in pg/mL

Measure: IL-4

Time: on the day 7,14,28 after enrollment

Description: IL-6 in pg/mL

Measure: IL-6

Time: on the day 7,14,28 after enrollment

Description: IL-10 in pg/mL

Measure: IL-10

Time: on the day 7,14,28 after enrollment

Description: TNF-α in nanogram(ng)/L

Measure: tumor necrosis factor(TNF)-α

Time: on the day 7,14,28 after enrollment

Description: γ-IFN in a thousand unit (KU)/L

Measure: γ-interferon(IFN)

Time: on the day 7,14,28 after enrollment

Description: CRP in microgram(μg)/L

Measure: C-reactive protein(CRP)

Time: on the day 7,14,28 after enrollment

Description: counts of CD4+ T-Lymphocytopenia in litre

Measure: CD4+ T-Lymphocytopenia

Time: on the day 7,14,28 after enrollment

Description: counts of CD8+ T-Lymphocytopenia in a litre

Measure: CD8+ T-Lymphocytopenia

Time: on the day 7,14,28 after enrollment

Description: counts of NK in a litre

Measure: natural killer cell(NK)

Time: on the day 7,14,28 after enrollment
4 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04290858
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
  3. Dyspnea
Interventions
  1. Drug: Nitric Oxide
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea
HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).

Measure: Time to clinical recovery

Time: 28 days
5 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04305457
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Nitric Oxide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Proportion of deaths from all causes

Measure: Mortality

Time: 28 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.

Measure: Time to clinical recovery

Time: 28 days

Other Outcomes

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days
6 The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations

This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza

NCT04313946
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Influenza With Pneumonia
  4. Flu Symptom
  5. Flu Like Illness
  6. Pneumonia, Interstitial
  7. Pneumonia, Ventilator-Associated
  8. Pneumonia Atypical
Interventions
  1. Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive

Measure: COVID-19 positive X-Rays

Time: 6 months

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative

Measure: COVID-19 negative X-Rays

Time: 6 months
7 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

NCT04321278
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
Interventions
  1. Drug: Hydroxychloroquine + azithromycin
  2. Drug: Hydroxychloroquine
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at 29 days after randomization

Measure: All-cause mortality

Time: 29 days after randomization

Description: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

Description: Number of days free from mechanical ventilation at 29 days after randomization

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

Description: Number of days that the patient was on mechanical ventilation after randomization

Measure: Duration of mechanical ventilation

Time: 29 days after randomization

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 29 days after randomization

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 29 days after randomization

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 29 days after randomization

Description: Morbimortality, daily life activities, mental health, and quality of life

Measure: Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life

Time: 3, 6, 9 and 12 months

Description: Leucocyte transcriptome

Measure: Assess whether the tested therapies may be affected by leucocyte phenotype

Time: Baseline

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 29 days after randomization

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 29 days after randomization

Description: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin

Measure: Laboratory abnormalities

Time: 29 days after randomization

Description: Occurrence of adverse events related to the use of the investigational products

Measure: Adverse events

Time: 29 days after randomization
8 Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method

Growing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.

NCT04322487
Conditions
  1. Coronavirus
  2. Epidemic Disease
  3. Pneumonia, Viral
Interventions
  1. Diagnostic Test: Lung ultrasound
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Scoring procedures Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. Score 2: The pleura line is broken. Below the breaking point, small to large consolidated areas (darker areas) appear with associated areas of white below the consolidated area (white lung). Score 3: The scanned area shows dense and largely extended white lung with or without larger consolidations At the end of the procedure, the clinician will write for each area the highest score obtained.

Measure: Lung ultrasound grading system for COVID-19 pneumonia

Time: At enrollment.
9 Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].

NCT04322565
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
Interventions
  1. Drug: Colchicine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale

Measure: Clinical improvement

Time: Day 28

Description: Live discharge from the hospital (whatever comes first)

Measure: Hospital discharge

Time: Day 28

Secondary Outcomes

Description: Number of death patients

Measure: Death

Time: Day 28

Description: 7-category ordinal scale

Measure: Clinical status

Time: Day 7, Day 14

Description: Number of patients with mechanical ventilhation

Measure: Mechanical ventilhation

Time: Day 28

Description: Days of hospitalization

Measure: Hospitalization

Time: Day 28

Description: Days to death from treatment initiation

Measure: Time from treatment initiation to death

Time: Day 28

Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart

Measure: Time to Negativization COVID 19

Time: Day 21

Description: Time to remission of fever in patients with T>37.5°C at enrollment

Measure: Fever

Time: Day 1,4,7,14,21,28
10 Time of Recovery and Prognostic Factors of COVID-19 Pneumonia

It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities. In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients. Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection. The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.

NCT04324684
Conditions
  1. Pneumonia, Viral
  2. Hypertension
  3. Diabetes Mellitus
  4. Obesity
  5. Cardiovascular Diseases
  6. Obstructive Lung Disease
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive Cardiovascular Diseases
HPO:Abnormal lung morphology Abnormality of the cardiovascular system Pneumonia Pulmonary obstruction

Primary Outcomes

Description: mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.

Measure: rate of recovery

Time: 3 weeks

Secondary Outcomes

Description: comparison of the survival curves (times to improvement) in the two groups (patients with and without complications) and among patients presenting with different types of complications

Measure: time to improvement

Time: 3 weeks

Description: the efficacy of different pharmaceutical treatment against Covid-19

Measure: efficacy of treatments

Time: 3 weeks

Description: liver, kidney or multiorgan failure, cardiac failure

Measure: organ failure

Time: 3 weeks
11 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036
Conditions
  1. Pulmonary Alveolar Proteinosis
  2. COPD
  3. Idiopathic Pulmonary Fibrosis
  4. Viral Pneumonia
  5. Coronavirus Infection
  6. Interstitial Lung Disease
Interventions
  1. Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
  2. Device: Centricyte 1000
  3. Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
  4. Drug: Liberase Enzyme (Roche)
  5. Drug: Sterile Normal Saline for Intravenous Use
MeSH:Infection Communicable Diseases Coron Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Intraalveolar phospholipid accumulation Pulmonary fibrosis

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months
12 COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.

NCT04327401
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Dexamethasone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.

Measure: Ventilator-free days

Time: 28 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Description: All-cause mortality rates at 28 days after randomization.

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days of mechanical ventilation from randomization to day 28.

Measure: Mechanical ventilation duration

Time: 28 days after randomization

Description: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: Score at 48 hours, 72 hours and 7 days after randomization

Other Outcomes

Description: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.

Measure: Intensive Care Unit free days

Time: 28 days after randomization
13 Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments

Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population. Goals: Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children. Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes. Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days. Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements. Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.

NCT04330261
Conditions
  1. COVID-19
  2. SARS-CoV-2 Infection
  3. Pediatric ALL
  4. Pneumonia, Viral
  5. Pandemic Response
Interventions
  1. Other: Exposure (not intervention) - SARS-CoV-2 infection
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.

Measure: Clinical characteristics of children with SARS-CoV-2

Time: 18 months

Description: Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.

Measure: Factors associated with severe COVID-19 outcomes

Time: 18 months

Secondary Outcomes

Description: Health care resource utilization for patient management (e.g. frequencies of isolation, laboratory testing, imaging, and supportive care, with associated costs) of both suspected and confirmed SARS-CoV-2 infected children according to changes in national and regional policies.

Measure: Health care resource utilization for COVID-19 patient management

Time: 18 months

Description: The sensitivity and specificity of various case screening policies for the detection of confirmed symptomatic SARS-CoV-2 infection (i.e. COVID-19) in children (e.g. addition of vomiting/diarrhoea).

Measure: Sensitivity and specificity of COVID-19 case screening policies

Time: 18 months
14 Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)

A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.

NCT04331613
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
  3. Virus; Pneumonia
  4. Acute Lung Injury
Interventions
  1. Biological: CAStem
MeSH:Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Syndrome
HPO:Pneumonia

Primary Outcomes

Description: Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment

Measure: Adverse reaction (AE) and severe adverse reaction (SAE)

Time: Within 28 days after treatment

Description: Evaluation by chest CT

Measure: Changes of lung imaging examinations

Time: Within 28 days after treatment

Secondary Outcomes

Description: Marker for SARS-CoV-2

Measure: Time to SARS-CoV-2 RT-PCR negative

Time: Within 28 days after treatment

Description: The duration of a fever above 37.3 degrees Celsius

Measure: Duration of fever (Celsius)

Time: Within 28 days after treatment

Description: Marker for efficacy

Measure: Changes of blood oxygen (%)

Time: Within 28 days after treatment

Description: Marker for efficacy

Measure: Rate of all-cause mortality within 28 days

Time: Within 28 days after treatment

Description: Counts of lymphocyte in a litre (L) of blood

Measure: Lymphocyte count (*10^9/L)

Time: Within 28 days after treatment

Description: Alanine aminotransferase in unit (U)/litre(L)

Measure: Alanine aminotransferase (U/L)

Time: Within 28 days after treatment

Description: Creatinine in micromole (umol)/litre(L)

Measure: Creatinine (umol/L)

Time: Within 28 days after treatment

Description: Creatine kinase in U/L

Measure: Creatine kinase (U/L)

Time: Within 28 days after treatment

Description: C-reactive in microgram (mg)/litre(L)

Measure: C-reactive protein (mg/L)

Time: Within 28 days after treatment

Description: Procalcitonin in nanogram (ng)/litre(L)

Measure: Procalcitonin (ng/L)

Time: Within 28 days after treatment

Description: Lactate in millimole(mmol)/litre(L)

Measure: Lactate (mmol/L)

Time: Within 28 days after treatment

Description: IL-1beta in picogram(pg)/millilitre(mL)

Measure: IL-1beta (pg/mL)

Time: Within 28 days after treatment

Description: IL-2 in pg/mL

Measure: IL-2 (pg/mL)

Time: Within 28 days after treatment

Description: IL-6 in pg/mL

Measure: IL-6 (pg/mL)

Time: Within 28 days after treatment

Description: IL-8 in pg/mL

Measure: IL-8 (pg/mL)

Time: Within 28 days after treatment
15 A Randomized, Controlled, Open-Label, Phase II Trial to Evaluate the Efficacy and Safety of Tocilizumab Combined With Pembrolizumab (MK-3475) in Patients With Coronavirus Disease 2019 (COVID-19)-Pneumonia

This is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial

NCT04335305
Conditions
  1. COVID-19
  2. Pneumonia, Viral
Interventions
  1. Drug: Tocilizumab
  2. Biological: Pembrolizumab (MK-3475)
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Assessed by hospital records

Measure: Percentage of patients with normalization of SpO2 ≥96% on room air (measured without any respiratory support for at least 15 minutes

Time: through day 14 after study treatment initiation

Secondary Outcomes

Description: Assessed by hospital records

Measure: Proportion of patients discharged from the emergency department and classified as low risk

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: Assessed by hospital records

Measure: Number of days of patient hospitalization

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: The clinical status will be assessed by the SOFA scores

Measure: Change from baseline in organ failure parameters

Time: Days 1, 3, 5, 7, 14 (+/- 1 day) and 28 (+/- 2 days) or until discharge whatever it comes first.

Description: Determined as percentage of dead patients

Measure: Proportion of mortality rate

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: Determined as: Time to invasive mechanical ventilation (if not previously initiated); Time to independence from non-invasive mechanical ventilation; Time to independence from oxygen therapy.

Measure: Analysis of the remission of respiratory symptoms

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: by using the same imaging technique (chest X-ray or thoracic CT scan)

Measure: Evaluation of the radiological response

Time: at days 1 and 28 (+/- 2 days)

Description: determined using oropharyngeal or anal swabs

Measure: Time to first negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR test

Time: within 28 days from study inclusion

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of absolute lymphocyte count (ALC),white blood cell count and white blood cell differential count

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of hemoglobin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of platelets

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of activated partial thromboplastin time (aPTT)

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of creatinine

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of glucose

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of total bilirubin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of albumin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0), SOFA scores.

Measure: Incidence of adverse events (AEs), incidence of prespecified AEs (safety and tolerability)

Time: Up to End of Study, defined as 90 ± 14 days after study entry
16 Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.

NCT04336345
Conditions
  1. Coronavirus Infections
  2. COVID-19
  3. Viral Pneumonia Human Coronavirus
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Mortality 30 days following hospital admission

Measure: Hospital mortality

Time: 30 days

Secondary Outcomes

Description: The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge

Measure: Length of stay in the intensive care unit

Time: Through study completion, an average of 30 days
17 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.

NCT04340466
Conditions
  1. Pneumonia, Viral
  2. Critically Ill
  3. Corona Virus Infection
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Cr Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28
18 Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19

Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies. The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management. Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray. However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.

NCT04341766
Conditions
  1. Pneumonia, Viral
  2. COVID-19
Interventions
  1. Other: No special intervention
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day one

Secondary Outcomes

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day 3

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day 14

Description: description of CT-scan abnormalities for Covid-19 patients

Measure: Charateristics of pulmonary CT-scan for Covid-19 patients

Time: Day 1

Description: description of CT-scan abnormalities for Covid-19 patients

Measure: Charateristics of pulmonary CT-scan for Covid-19 patients

Time: Day 3

Description: description of CT-scan abnormalities for Covid-19 patients

Measure: Charateristics of pulmonary CT-scan for Covid-19 patients

Time: Day 14
19 Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection

Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease. During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection. The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome. The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.

NCT04344288
Conditions
  1. Viral Pneumonia Human Coronavirus
  2. COVID-19
Interventions
  1. Drug: Prednisone
  2. Other: Control group
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.

Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.

Time: 7 days

Secondary Outcomes

Description: level1: not hospitalized no limited activities, level 7: death

Measure: disease severity assessed on a 7-level ordinal scale

Time: 7 days

Measure: number of patients with a supplemental oxygen use

Time: 7 days

Description: Reduction of radiological signs on chest imaging

Measure: radiological signs on chest imaging

Time: 7 days

Measure: number of patients transferred to intensive care unit

Time: 21 days

Measure: number of patients requiring invasive ventilation

Time: 21 days

Description: duration on days

Measure: Duration of oxygen therapy

Time: 21 days

Measure: number of adverse events induced by corticosteroid treatment

Time: 21 days

Measure: number of patients with infections other than SARS-CoV-2

Time: 21 days

Measure: number of deaths

Time: 21 days
20 Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial

This is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection. The study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of SARS-CoV-2 pneumonia in patients who will be hospitalised.

NCT04344951
Conditions
  1. Pneumonia, Viral
  2. Covid-19
Interventions
  1. Drug: UNIKINON (Chloroquine phosphate) 200mg tablets
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation.

Measure: 50% reduction in symptom score for patients with lower respiratory tract infection

Time: Day 8 visit from study initiation

Description: Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection on day 8 visit from study initiation.

Measure: Lack of progression for patients with upper respiratory tract infection

Time: Day 8 visit from study initiation

Secondary Outcomes

Description: Lower respiratory tract infection rating takes place. The symptoms checked are: Cough, Chest pain, Dyspnea, expectoration. For each symptom score is given from 0 to 3 depending on the intensity and they are summed.

Measure: Comparison of the primary endpoint with respective patients not receiving the treatment

Time: Day 14 visit from study initiation

Description: It is defined as the presence of both of the following: Respiratory quotient (pO2 / FiO2) less than 150 Need for treatment with CPAP or mechanical ventilation

Measure: Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment.

Time: Day 14 visit from study initiation

Description: Frequency of AEs and SAEs

Measure: Frequency of AEs and SAEs

Time: Day 14 visit from study initiation
21 Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT04345289
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Viral Pneumonia
Interventions
  1. Biological: Convalescent anti-SARS-CoV-2 plasma
  2. Other: Infusion placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Composite outcome

Measure: All-cause mortality or need of invasive mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of participants with adverse events with possible relation to study drug

Measure: Frequency of adverse events

Time: 90 days

Description: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

Measure: Frequency of severe adverse events

Time: 90 days

Description: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities

Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

Time: 90 days

Description: Number of days without mechanical ventilation

Measure: Ventilator-free days

Time: 28 days

Description: Number of days without organ-failure

Measure: Organ failure-free days

Time: 28 days

Description: Number of days in ICU

Measure: Duration of ICU stay

Time: 90 days

Description: Number of deaths by any cause

Measure: Mortality rate

Time: 7, 14, 21, 28 and 90 days

Description: Days from the date of hospital admission for COVID-19 to the date of discharge

Measure: Length of hospital stay

Time: 90 days

Description: Days requiring supplement oxygen

Measure: Duration of supplemental oxygen

Time: 90 days
22 Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.

NCT04345861
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
Interventions
  1. Drug: Hydroxychloroquine + placebo
  2. Drug: hydroxychloroquine + azithromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)

Measure: Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).

Time: up to Day 11

Secondary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29

Measure: Clinical status assessed by ordinal scale

Time: up to Day 29

Description: Necessity for transfer to Intensive care unit

Measure: transfer to ICU

Time: up to Day 29

Description: days from admission to hospital discharge

Measure: Length of hospital day

Time: up to Day 29

Description: incidence of all-cause mortality

Measure: Hospital Mortality

Time: Day 29

Description: Need to mechanical ventilation

Measure: Need to Mechanical Ventilation

Time: up to Day 29

Description: adverse reactions

Measure: Occurence of grade 3-4 adverse event

Time: up to Day 29

Description: ECG

Measure: QTc Lengthening

Time: up to Day 11

Description: Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework

Measure: Evolution of pulmonary CT scan images

Time: up to Day 11
23 An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

NCT04347031
Conditions
  1. Pneumonia, Viral
  2. Respiratory Failure
Interventions
  1. Drug: Mefloquine
  2. Drug: Hydroxychloroquine
  3. Combination Product: Mefloquine + azithromycin + / - tocilizumab
  4. Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: The number of patients with development of respiratory failure requiring transfer to the ICU.

Measure: 1st primary endpoint for group 1

Time: up to 10 days

Description: The period of clinical recovery.

Measure: 2nd primary endpoint for group 1

Time: up to 10 days

Description: The period of clinical recovery.

Measure: 1st primary endpoint for group 2

Time: up to 10 days

Description: Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)

Measure: 2nd primary endpoint for group 2

Time: through study completion, an average of 3 months

Secondary Outcomes

Description: A change in viral load by conducting PCR assay through different timeframes

Measure: 1st secondary endpoint for group 1

Time: on days 5 and 10

Description: Frequency of clinical cure on day 10 from the start of therapy

Measure: 2nd secondary endpoint for group 1

Time: on day 10

Description: The retention time of the reaction temperature from the start of the treatment.

Measure: 3d secondary endpoint for group 1

Time: up to 10 days

Description: Concentration of C-reactive protein in blood plasma.

Measure: 4th secondary endpoint for group 1

Time: up to 10 days

Description: Respiratory index.

Measure: 5th secondary endpoint for group 1

Time: up to 10 days

Description: Frequency appearance unwanted phenomena and serious unwanted phenomena

Measure: 6th secondary endpoint for group 1

Time: up to 10 days

Description: A change in viral load by conducting PCR assay through different timeframes

Measure: 1st secondary endpoint for group 2

Time: on days 5 and 10

Description: Respiratory index.

Measure: 2nd secondary endpoint for group 2

Time: up to 10 days

Description: The retention time of the reaction temperature from the start of treatment.

Measure: 3d secondary endpoint for group 2

Time: up to 10 days

Description: Concentration of C-reactive protein in blood plasma.

Measure: 4th secondary endpoint for group 2

Time: up to 10 days

Description: Number of patients required transition to alternative therapy schedule

Measure: 5th secondary endpoint for group 2

Time: up to 10 days

Description: Frequency of adverse events and serious adverse events

Measure: 6th secondary endpoint for group 2

Time: up to 10 days
24 A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic

Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room. The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.

NCT04353141
Conditions
  1. COVID
  2. Pregnancy Complications, Infectious
  3. Pregnancy Related
  4. Pregnancy, High Risk
  5. Pregnancy Disease
  6. Pneumonia
  7. Pneumonia, Viral
  8. Diagnoses Disease
Interventions
  1. Diagnostic Test: standardized Lung Ultrasound (LUS) examination
MeSH:Pregnancy Complications, Infectious Pneumonia, Viral Pneumonia Pregnancy Complications
HPO:Pneumonia

Primary Outcomes

Description: The primary endpoint is diagnostic performance in terms of the area under the receiver operating characteristic curve (AUC, also known as the c-statistic) and sensitivity and specificity with regard to the prediction of poor outcome. Outcome at one week from admission: good outcome includes discharge or inpatient breathing in free air; poor outcome includes patient with oxygen support, patients with CPAP/ high oxygen flow cannula, or patient with endotracheal intubation during the week.

Measure: Diagnostic performance of LUS to predict poor outcome

Time: outcome one week after enrollment into the study
25 SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

This protocol provides access to eculizumab treatment for participants with severe COVID-19.

NCT04355494
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Interventions
  1. Biological: eculizumab
MeSH:Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Syndrome
HPO:Pneumonia

26 COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1

This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.

NCT04356508
Conditions
  1. COVID-19
  2. SARS-CoV-2
  3. 2019-nCoV
  4. Pneumonia, Viral
Interventions
  1. Drug: Nivolumab
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Viral load changes in NPS based on SARS-CoV-2 RT-PCR

Measure: Viral clearance kinetics

Time: From diagnosis to recovery, assessed up to 6 months

Secondary Outcomes

Description: Incidence and severity of treatment-related adverse events

Measure: Treatment-related adverse events of nivolumab (Intervention arm only)

Time: Up to 1 year after nivolumab dosing

Description: Changes in lymphocyte counts

Measure: Lymphocyte kinetics

Time: On days 1, 4, 6, 8, 10 and 28 from study enrollment

Description: Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)

Measure: Cytokine kinetics

Time: On days 1, 4, 6, 8 and 10 from study enrollment

Measure: Length of inpatient stay due to COVID-19

Time: From hospital admission to discharge, assessed up to 6 months
27 Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

The search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support. Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.

NCT04358588
Conditions
  1. Coronavirus Infection
  2. COVID-19
  3. Pneumonia, Viral
Interventions
  1. Drug: iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

28 Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2

Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

NCT04359706
Conditions
  1. Sars-CoV2
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: relative abundances and diversity indices

Measure: Composition of the fecal bacterial and fungal microbiota

Time: At 28 days

Secondary Outcomes

Description: Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls

Measure: Analysis of the faecal microbiota from rectal swab

Time: at baseline and every 7 days during 28 days

Description: Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls

Measure: Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid

Time: at baseline and every 7 days during 28 days

Description: Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline

Measure: Serum inflammatory markers changes

Time: at 28 days,

Description: changes in Cytokine/ chemokine from baseline

Measure: Inflammatory markers changes

Time: at 28 days,

Description: death

Measure: Mortality

Time: at 28 days,

Description: Number of days alive without mechanical ventilation

Measure: mechanical ventilation free days

Time: at 28 days,
29 PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)

COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition due to hypoxemic respiratory failure with the background of viral pneumonia. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the elimination of atelectasis developed by inflammation in the lung parenchyma The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations. Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside.

NCT04360837
Conditions
  1. COVID-19
  2. Virus; Pneumonia
  3. Atelectasis
Interventions
  1. Procedure: alveolar recruitment
MeSH:Pneumonia, Viral Pneumonia Pulmonary Atelectasis
HPO:Atelectasis Pneumonia

Primary Outcomes

Description: Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.

Measure: Changes in lung compliance

Time: 20 minutes

Description: Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.

Measure: Change in global impedance

Time: 20 minutes

Description: Estimation of change in global impedance (%) on a daily manner.

Measure: Change in recruitability

Time: 7 days

Secondary Outcomes

Description: Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment

Measure: Gas exchange

Time: 20 minutes and 7 days

Description: Change in plateau pressure (cmH2O) following recruitment

Measure: Plateau pressure

Time: 20 minutes and 7 days

Description: Change in end expiratory lung impedance (%)

Measure: End expiratory lung impedance (EELI)

Time: 20 minutes and 7 days

Description: Change in antero-to-posterior ventilation ratio (%) following intervention

Measure: Antero-to-posterior ventilation ratio

Time: 20 minutes and 7 days

Description: Change in center of ventilation (%) following intervention

Measure: Center of ventilation

Time: 20 minutes and 7 days

Description: Change in global inhomogeneity index (%) following intervention

Measure: Global inhomogeneity index

Time: 20 minutes and 7 days
30 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

NCT04365101
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Pneumonia
  5. Pneumonia, Viral
  6. Lung Diseases
  7. Respiratory Tract Disease
  8. Respiratory Tract Infections
  9. Coronaviridae Infections
  10. Nidovirales Infections
  11. RNA Virus Infections
  12. Virus Disease
  13. Immunologic Disease
  14. ARDS
  15. Immunologic Factors
  16. Physiological Effects of Drugs
  17. Antiviral Agents
  18. Anti-infective Agents
  19. Analgesics
  20. Antimetabolites, Antineoplastic
Interventions
  1. Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus I Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral RNA Virus Infections Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 6 months

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Phase 1: Rate of clearance of SARS-CoV-2

Time: Up to 6 months

Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.

Measure: Phase 1: Rate of clinical improvement

Time: Up to 6 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.

Measure: Phase 2: Time to Clearance of SARS-CoV-2

Time: Up to 28 days

Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.

Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score

Time: Up to 28 days

Secondary Outcomes

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 6 months

Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 6 months

Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 6 months

Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 6 months

Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 6 months

Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.

Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score

Time: Up to 28 days

Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days
31 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.

NCT04366089
Conditions
  1. COVID
  2. SARS-CoV 2
  3. Pneumonia, Viral
  4. Coronavirus Infection
Interventions
  1. Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care
  2. Dietary Supplement: SivoMixx (200 billion)
  3. Drug: Azithromycin
  4. Drug: hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

Measure: delta in the value of interleukin (IL)-1

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of CD8+ CD38/ HLA-DR

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days
32 Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol

This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

NCT04368377
Conditions
  1. Pneumonia, Viral
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Embolism and Thrombosis
Interventions
  1. Drug: Tirofiban Injection
  2. Drug: Clopidogrel
  3. Drug: Acetylsalicylic acid
  4. Drug: Fondaparinux
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency Thrombosis Embolism Embolism and Thrombosis
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment

Measure: P/F ratio

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.

Measure: A-a O2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Secondary Outcomes

Description: Number of days on continuous positive end expiratory pressure (CPAP)

Measure: CPAP duration

Time: From the first day of study drugs administration (T0) until day 7 post study drugs administration

Description: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation

Measure: In-hospital change in intensity of the respiratory support

Time: At baseline and 72 and 168 hours after treatment initiation

Description: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaCO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: HCO3- difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: Lactate difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Hb difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Plt difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)

Measure: Adverse effects

Time: From the first day of study drugs administration until day 30 post study drugs administration
33 A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

NCT04369469
Conditions
  1. COVID-19 Severe Pneumonia
  2. Acute Lung Injury
  3. Acute Respiratory Distress Syndrome
  4. Pneumonia, Viral
Interventions
  1. Biological: Ravulizumab
  2. Other: Best Supportive Care
MeSH:Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Syndrome
HPO:Pneumonia

Primary Outcomes

Measure: Survival (based on all-cause mortality) at Day 29

Time: Baseline, Day 29

Secondary Outcomes

Measure: Number of days free of mechanical ventilation at Day 29

Time: Baseline, Day 29

Measure: Duration of intensive care unit stay at Day 29

Time: Baseline, Day 29

Measure: Change from baseline in Sequential Organ Failure Assessment at Day 29

Time: Baseline, Day 29

Measure: Change from baseline in SpO2/FiO2 at Day 29

Time: Baseline, Day 29

Measure: Duration of hospitalization at Day 29

Time: Baseline, Day 29

Measure: Survival (based on all-cause mortality) at Day 60 and Day 90

Time: Baseline, Day 60, Day 90
34 Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia: a Multicenter Study in the Italian Outbreak

Is Lung Ultrasound really useful in diagnosing COVID19? What can be the usefulness of the Lung Ultrasound in the COVID19 epidemic? In the current state of the art, Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Lung Ultrasound in the diagnosis of COVID-19 are not yet known. Alveolar-interstitial lung diseases such as viral pneumonia and ARDS seems to have a specific ultrasound pattern that distinguishes them from bacterial pneumonia, preferentially represented by B lines, morphological irregularity of the pleural line, and small subpleural consolidations, but they could share these patterns with other pathologies, reducing specificity. In Italy, the Lung Ultrasound represents a consolidated method for the evaluation and management of all patients who come to the ER, and what we are sure of is its high sensitivity in identifying pathological patterns. Our preliminary data suggest that Lung Ultrasound is highly reliable not to include but to exclude the diagnosis of COVID-19 in patients with respiratory symptoms.

NCT04370275
Conditions
  1. COVID-19
  2. Pneumonia, Viral
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Lung Ultrasound accuracy in rule-out of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards

Measure: Negative Predictive Value of Lung Ultrasound in the diagnosis of COVID-19

Time: 30 days

Secondary Outcomes

Description: Lung Ultrasound accuracy in rule-in of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards

Measure: Positive Predictive Value of Lung Ultrasound in the diagnosis of COVID-19

Time: 30 days

Measure: Sensitivity and Specificity of Lung Ultrasound in the diagnosis of COVID-19

Time: 30 days
35 Early Short Course Corticosteroids in Hospitalized Patients With COVID-19

The investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.

NCT04374071
Conditions
  1. COVID
  2. Pneumonia, Viral
Interventions
  1. Drug: Methylprednisolone
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of patients transferred to ICU is each of the groups

Measure: Transfer to Intensive care unit (ICU)

Time: 14 days followup for every patient in each group

Description: Number of patients that needed mechanical ventilation in each of the groups

Measure: Need for Mechanical Ventilation

Time: 14 days followup for every patient in each group

Description: Number of patients who died in each of the groups

Measure: Mortality

Time: 14 days followup for every patient in each group

Secondary Outcomes

Description: Number of patients who developed ARDS of varying severity per Berlin classification in each of the groups

Measure: Development and Severity of ARDS

Time: 14 days followup for every patient in each group

Description: LOS in each of the groups

Measure: Length of hospital stay (LOS).

Time: 14 days followup for every patient in each group
36 Single-center, Prospective, Open-label, Comparator Study, Blind for Central Accessor to Access the Efficacy, Safety, and Tolerability of Inhalations of Low-doses of Melphalan in Patients With Pneumonia With Confirmed or Suspected COVID-19

This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.

NCT04380376
Conditions
  1. COVID-19
  2. Viral Pneumonia
Interventions
  1. Drug: Melphalan
  2. Other: Standard of care
MeSH:Pneumonia, Viral Pneumonia Respiratory Aspiration
HPO:Pneumonia

Primary Outcomes

Description: The number of patients with the clinical improvement is defined as an improvement of two points (from the status at baseline) on an ordinal scale of clinical improvement on day 28 or discharge from hospital ( whatever occurs earlier) Death Hospitalized with Invasive mechanical ventilation plus additional organ support - ECMO / pressors / RRT Hospitalized with intubation and mechanical ventilation Hospitalized on non-invasive ventilation or high flow oxygen. Hospitalized on a mask or nasal prongs. Hospitalized no oxygen therapy. Ambulatory, with limitation of activities. Ambulatory, no limitation of activities. I. No clinical or virological evidence of infection.

Measure: The changes of COVID Ordinal Outcomes Scale

Time: baseline vs Day 14, day 28

Description: Percentage of the patients with clinical recovery which is defined as a normalisation of fever, respiratory rate, and oxygen saturation, and improvement of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalization and improvement criteria: Fever - <37°C, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.

Measure: Percentage of the patients with Clinical Recovery

Time: baseline vs day 7, day 14, day 28

Description: The evaluation of changes in modified Borg dyspnea scale. From 0 to 10 units.A lower score means a better clinical result (0 is the absence of dyspnea, and 10 - is maximal dyspnea). Minimal clinically important difference is 1 unit.

Measure: The changes of the Borg's scale

Time: Baseline vs day 7, day 14, day 28

Secondary Outcomes

Description: Change in C-reactive protein (CRP) level from baseline in mg/ml. A lower level of CRP means a better clinical result.

Measure: CRP level

Time: baseline, day 7, Day 14, Day 28

Description: Change in blood absolute lymphocyte count from baseline. A higher number of lymphocytes means a better clinical result.

Measure: Lymphocyte count

Time: baseline, day 7, Day 14, Day 28

Description: Change in blood D-dimer level from baseline. A lower level of D-dimer means a better clinical result.

Measure: D-dimer

Time: baseline, day 7, Day 14, Day 28

Description: Change in peripheral blood IL-6 level from baseline. A lower level of IL-6 means a better clinical result.

Measure: IL-6

Time: baseline, day 7, Day 14, Day 28

Description: Percentage of patients without artificial lung ventilation during the study. A lower percentage of patients means a better clinical result.

Measure: Percentage of patients without artificial lung ventilation

Time: baseline, day 7, Day 14, Day 28
37 Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study

Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.

NCT04380818
Conditions
  1. Pneumonia, Viral
Interventions
  1. Radiation: Low-dose radiotherapy
  2. Drug: Hydroxychloroquine Sulfate
  3. Drug: Ritonavir/lopinavir
  4. Drug: Tocilizumab Injection [Actemra]
  5. Drug: Azithromycin
  6. Drug: Corticosteroid
  7. Drug: Low molecular weight heparin
  8. Device: Oxygen supply
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined

Measure: Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%

Time: Day 2 after interventional radiotherapy

Secondary Outcomes

Description: Lung toxicity measured according to CTCAEv5

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: Day 30 and day 90 after interventional radiotherapy

Description: Chest CT

Measure: Change of the radiological image

Time: Days 7 and day 30 after interventional radiotherapy

Description: Death of any cause

Measure: Overall mortality

Time: Day 15 and Day 30 after interventional radiotherapy

Description: Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)

Measure: Measure of pro-inflammatory interleukins

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: TGF-β (ng/ml)

Measure: Measure of trasforming growth factor (TGF-b)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: TNF-α (pg/ml)

Measure: Measure of tumor necrosis factor alpha (TNF-a)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: Overexpression of L-, E-, and P-selectin

Measure: Determining overexpression of pro-inflammatory selectin

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: Overexpression of ICAM-1, VCAM

Measure: Determining cell adhesion molecules (CAMs)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: PON-1(paraoxonase and arylesterase activity) (IU/ml)

Measure: Measure of marker of oxidative stress PON-1

Time: Days 1, day 4 and day 7 after interventional radiotherapy
38 Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.

NCT04381364
Conditions
  1. Covid-19
  2. Pneumonia, Viral
  3. Sars-CoV2
Interventions
  1. Drug: Ciclesonide Inhalation Aerosol
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time (in days) of received supplemental oxygen therapy (defined as being alive and discharged from hospital to home or at least 48 h of not receiving oxygen therapy during hospitalization).

Measure: Duration of received supplemental oxygen therapy

Time: 30 days after study inclusion

Secondary Outcomes

Description: Rate of and time to (in days) received invasive mechanical ventilation or all-cause death

Measure: Invasive mechanical ventilation or all-cause death (key secondary outcome)

Time: 30 days after study inclusion

Description: Rate of and time to (in days) death of any cause

Measure: All cause death

Time: 30 days after study inclusion

Description: Rate of and time to (in days) received invasive mechanical ventilation

Measure: Invasive mechanical ventilation

Time: 30 days after study inclusion

Description: Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale

Measure: Remaining dyspnea symptoms

Time: 30-35 days and 5-7 months after inclusion
39 High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia

The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

NCT04381923
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Hypoxemic Respiratory Failure
  3. Pneumonia, Viral
  4. COVID
Interventions
  1. Device: Helmet Continuous Positive Airway Pressure (CPAP)
  2. Device: High Flow Nasal Oxygen (HFNO)
MeSH:Coronavirus Infec Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.

Measure: Ventilator-Free Days (VFD)

Time: 28 days

Secondary Outcomes

Description: Days spent in the ICU and hospital after time of enrollment

Measure: ICU and Hospital Length of Stay

Time: 28 days

Description: Incidence and time to intubation in days after the time of enrollment

Measure: Intubation

Time: 28 days

Description: Incidence of RRT after the time of enrollment

Measure: Renal Replacement Therapy (RRT)

Time: 28 days

Description: Death from any cause during after the time of enrollment

Measure: Mortality

Time: 28 days, 90 days
40 Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

NCT04382547
Conditions
  1. COVID
  2. Covid-19
  3. Coronavirus
  4. Pneumonia
  5. Pneumonia, Viral
  6. Pneumonia, Interstitial
  7. Sars-CoV2
Interventions
  1. Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
  2. Other: Standard treatment according to the Clinical protocols
MeSH:Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Number of patients cured, assessed by PCR in addition to chest CT scan

Measure: Number of cured patients

Time: 3 weeks

Secondary Outcomes

Description: MSC infusion related adverse events assessed by blood count, liver and function tests

Measure: Number of patients with treatment-related adverse events

Time: 3 weeks
41 Predicting Outcomes for Covid-19 Using Sonography

This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.

NCT04384055
Conditions
  1. COVID-19
  2. Pneumonia, Viral
Interventions
  1. Diagnostic Test: Lung Ultrasound
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)

Measure: Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula

Time: 28 days from initial evaluation

Secondary Outcomes

Measure: Number of Patients Requiring Mechanical Ventilation

Time: 28 days from initial evaluation

Measure: Number of Patients Requiring Supplemental Oxygen Usage

Time: 28 days from initial evaluation

Measure: Duration of Supplemental Oxygen Usage

Time: 28 days from initial evaluation

Description: Duration of Hospitalization (days)

Measure: Length of Stay

Time: 28 days from initial evaluation

Description: Descriptive analysis of ultrasound findings in Covid-19

Measure: Characterization of Ultrasound Findings

Time: 28 days from initial evaluation
42 Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

NCT04385823
Conditions
  1. Respiratory Syndrome, Acute, Severe
  2. Hypoxic Respiratory Failure
  3. Viral Pneumonia
Interventions
  1. Device: patients receiving nasal high flow
MeSH:Pneumonia, Viral Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: values of ROX index during ICU stay

Measure: Changes in ROX index

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Secondary Outcomes

Description: percentage of patients requiring intubation

Measure: NHF failure

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of flow used with NHF

Measure: NHF flow

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of inspired fraction in oxygen used with NHF

Measure: NHF inspired fraction in oxygen

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of pulse oxymetry during NHF therapy

Measure: oxygenation

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: respiratory rate during NHF therapy

Measure: respiratory status

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: defining the values of ROX index associated with intubation

Measure: prediction of intubation

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: defining the values of ROX index associated with NHF success (no intubation required)

Measure: prediction of NHF success

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
43 Major Determinants of COVID-19 Associated Pneumonia

Molecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases. Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal. Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies. In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.

NCT04387799
Conditions
  1. Pneumonia, Viral
  2. Pneumonia, Bacterial
  3. Coronavirus Infection
  4. Obstructive Lung Disease
Interventions
  1. Diagnostic Test: Serology for Covid-19
MeSH:Pneumonia, Bacterial Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive
HPO:Abnormal lung morphology Pneumonia Pulmonary obstruction

Primary Outcomes

Description: assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.

Measure: Serology

Time: 3 weeks

Secondary Outcomes

Description: to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.

Measure: Efficacy of CT scan and Serology

Time: 3 weeks

Description: the efficacy of different pharmaceutical treatments against Covid-19

Measure: Efficacy of different pharmaceutical treatments

Time: 3 weeks
44 Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2

Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press). This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.

NCT04388657
Conditions
  1. COVID
  2. Embolism and Thrombosis
  3. Pneumonia, Viral
Interventions
  1. Diagnostic Test: Echo-Doppler
MeSH:Pneumonia, Viral Pneumonia Thrombosis Embolism Embolism and Thrombosis
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.

Measure: percentage of patients with one or more DVTs.

Time: 28 days
45 COVID-19 Imaging Features

The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease.

NCT04394026
Conditions
  1. Viral Pneumonia
  2. COVID
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluate RX imaging aspects at the time of diagnosis and until discharge.

Measure: Describe qualitative and quantitative variables

Time: Through study completion, an average of 5 months

Description: Evaluate CT imaging aspects at the time of diagnosis and until discharge.

Measure: Describe qualitative and quantitative variables

Time: Through study completion, an average of 5 months

Description: Correlate imaging findings to OS

Measure: Ability of imaging to predict disease progression

Time: Through study completion, an average of 5 months

Description: Correlate imaging findings over time

Measure: Ability of imaging to predict disease evolution

Time: Through study completion, an average of 5 months

Secondary Outcomes

Description: Correlate imaging findings to age and sex

Measure: Imaging findings and demographic data

Time: Through study completion, an average of 5 months

Description: Correlate imaging findings to laboratory values

Measure: Imaging findings and laboratory exams

Time: Through study completion, an average of 5 months
46 Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182
Conditions
  1. Pneumonia, Viral
  2. Cytokine Storm
Interventions
  1. Radiation: Ultra-Low-dose radiotherapy
  2. Device: ventilatory support with oxygen therapy
  3. Drug: Lopinavir/ritonavir
  4. Drug: Hydroxychloroquine
  5. Drug: Azithromycin
  6. Drug: Piperacillin/tazobactam
  7. Drug: Low molecular weight heparin
  8. Drug: Corticosteroid injection
  9. Drug: Tocilizumab
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 2

Time: At 2 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2

Time: At 2 days after RT

Secondary Outcomes

Description: Pa02 / Fi02 > 300 mmHg

Measure: Blood Gas Analysis at Day 2

Time: At 2 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 2

Time: At 2 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 5

Time: At 5 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5

Time: At 5 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 5

Time: At 5 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 7

Time: At 7 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7

Time: At 7 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 7

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7

Time: At 7 days after RT

Description: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)

Measure: Recovery time

Time: From RT administration until hospital discharge or death

Description: COVID-19 negativization test

Measure: COVID-19 status

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1

Time: At 1 month after RT

Description: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.

Measure: Acute Toxicity

Time: 1-3 months after RT
47 Trial of Silymarin in Adults With COVID-19 Pneumonia

A randomized placebo controlled trial to assess the clinical outcome in COVID-19 Pneumonia following administration of Silymarin owing to its role as a p38 MAPK pathway inhibitor and its antiviral, anti-inflammatory and anti-oxidant effects

NCT04394208
Conditions
  1. COVID-19
  2. Viral Pneumonia Human Coronavirus
Interventions
  1. Drug: Silymarin
  2. Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Defined as the time from randomization to an improvement of two points (from the status of randomization) on seven category ordinal scale or live discharge from the hospital, whichever comes first.

Measure: Time to clinical improvement

Time: 7-28 days

Secondary Outcomes

Description: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14

Measure: Clinical outcome

Time: 7-14 days

Description: Time in days patient was intubated

Measure: Duration of Mechanical Ventilation

Time: Randomization till hospital discharge or death whichever came first, assessed up to 28 days

Description: Total days of hospitalization

Measure: Hospitalization

Time: Randomization till hospital discharge or death whichever came first, assessed up to 28 days

Description: number of days patient remained with positive RT-PCR SARS-CoV-2 swab

Measure: Virologic Response

Time: Randomization till discharge, up to 28 days

Description: Any adverse events whether related to medication or not

Measure: Adverse events

Time: Randomization till hospital discharge, up to 28 days
48 A Randomized, Double Blind, Placebo-controlled Trial of Mavrilimumab for Acute Respiratory Failure Due to COVID-19 Pneumonia With Hyper-inflammation (the COMBAT-19 Trial)

This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.

NCT04397497
Conditions
  1. Covid-19
  2. Acute Respiratory Failure
  3. ARDS, Human
  4. Sars-CoV2
  5. Viral Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan- Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm

Measure: Reduction in the dependency on oxygen supplementation

Time: within day 14 of treatment

Secondary Outcomes

Description: Response is defined as a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Proportion of responders (using the WHO 7-point ordinal scale)

Time: Day 7, 14, and 28

Description: Time from date of randomization to the date with a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Time to response (using the WHO 7-point ordinal scale)

Time: Within day 28 of intervention

Description: Proportion of patients with at least two-point improvement in clinical status

Measure: Proportion of improving patients (using the WHO 7-point ordinal scale)

Time: At day 7, 14, and 28

Description: Time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner

Measure: Time to resolution of fever

Time: Within day 28 of intervention

Description: COVID-19-related death

Measure: Reduction in case fatality

Time: Within day 28 of intervention

Description: Proportion of hospitalized patients who died or required mechanical ventilation (WHO Categories 6 or 7)

Measure: Proportion of patient requiring mechanical ventilation/deaths

Time: Within day 14 of intervention

Description: Change of the following serological markers over follow-up (C-reactive protein; Ferritin; D-Dimer)

Measure: Change in biochemical markers

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Median changes of NEWS2 score from baseline

Measure: Median changes in the National Early Warning Score 2 (NEWS2)

Time: At day 7, 14, and 28

Description: Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first)

Measure: Time to clinical improvement as evaluated with the National Early Warning Score 2 (NEWS2)

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Variations from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern,parenchymal consolidations, and evolution towards fibrosis.

Measure: Variations in radiological findings

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Number of patients with treatment- related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: By day 84

Other Outcomes

Description: To evaluate the primary and secondary endpoints in different subgroups of patients: mild respiratory failure: PaO2/FiO2 ≤ 300 and > 200 mmHg; moderate respiratory failure: PaO2/FiO2 ≤ 200 and > 100 mmHg

Measure: Clinical efficacy of mavrilimumab compared to the control arm by clinical severity

Time: Within day 28 of intervention

Description: Median changes in serum IL-6

Measure: Changes in serum IL-6 (exploratory biomarker)

Time: By day 84

Description: Median changes in serum IL-1 receptor antagonist

Measure: Changes in serum IL-1RA (exploratory biomarker)

Time: By day 84

Description: Median changes in serum TNF-alpha

Measure: Changes in serum TNF-alpha (exploratory biomarker)

Time: By day 84

Description: Median variations in haemoglobin and leucocyte counts

Measure: Changes in CBC + differential (exploratory biomarker)

Time: By day 84

Description: Median titres od anti-SARS-CoV2 antibodies

Measure: Level of anti-SARS-CoV2 antibodies (exploratory biomarker)

Time: By day 84

Description: Proportion of patients with a positive swab for SARS-CoV2 by PCR

Measure: Virus eradication (exploratory biomarker)

Time: By day 84

Description: Proportion of patients who developed anti-drug antibodies

Measure: Anti-drug antibodies (exploratory biomarker)

Time: By day 84
49 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04397692
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS-CoV 2
  4. Nitric Oxide
  5. Respiratory Disease
  6. Pneumonia, Viral
  7. Inhaled Nitric Oxide
Interventions
  1. Device: Nitric Oxide delivered via LungFit™ system
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disord Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration measured by need for NIV, HFNC or intubation

Measure: Time to deterioration

Time: 14 Days

Secondary Outcomes

Description: Time to non-invasive ventilation

Measure: Time to NIV

Time: 14 Days

Description: Time to high flow nasal cannula

Measure: Time to HFNC

Time: 14 Days

Description: Time to intubation

Measure: Time to intubation

Time: 14 days

Description: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Time: 14 days

Other Outcomes

Description: Need for supplemental oxygen

Measure: Need for supplemental oxygen

Time: 14 days

Description: Change in viral load

Measure: Change in viral load

Time: 30 days

Description: Duration of the Hospital Length of Stay (LOS)

Measure: Duration of the Hospital Length of Stay (LOS)

Time: 14 days

Description: Mortality rate at Day 30

Measure: Mortality rate at Day 30

Time: 30 days
50 The Utility of Bedside Lung Ultrasonography on Diagnosis of COVID-19 at Emergency Department

Novel Coronavirus 2019 Disease (COVID-19) mortality is highly associated with viral pneumonia and its complications. Accurate and prompt diagnosis shown to be effective to improve outcome by providing early treatment strategies. While chest X-ray (CXR) and computerized tomography (CT) are defined as gold standard, given the advantage of being an ionized radiation free, practical technique point of care ultrasound (POCUS) is also reported as a diagnostic tool for COVID-19. There are limited studies regarding the importance of POCUS in diagnosis and review of COVID-19. Therefore the aim of this study is to evaluate the utility of bedside lung ultrasound on diagnosis of COVID-19 for patients admitted to emergency department .

NCT04399681
Conditions
  1. COVID
  2. Pneumonia, Viral
Interventions
  1. Device: Bedside lung ultrasound
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19

Measure: Presence of viral pneumonia caused by COVID 19

Time: 3 months
51 Development and Validation of Predictive Models for Intensive Care Admission and Death of COVID-19 Patients in a Secondary Care Hospital in Belgium.

To build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines. The outcomes of the study are (i) admission in the Intensive Care Unit admission and (ii) death. All patients admitted in the Emergency Department with a positive reverse transcription-polymerase chain reaction SARS-COV2 test were included in the study. Routine clinical and laboratory data were collected at their admission and during their stay. Chest X-Rays and CT-Scans were performed and analyzed by a senior radiologist. Generalized Linear Models using a binomial distribution with a logit link function (R software version X) were used to develop predictive scores for (i) admission to ICU among emergency ward patients; (ii) death among ICU patients. A first panel of Number Models with the highest AIC (BIC) was preselected. Ten-fold cross-validation was then used to estimate the out-of-sample prediction error among these preselected models. The one with the smallest prediction error was in the end singled out .

NCT04401228
Conditions
  1. COVID19
  2. Pneumonia, Viral
  3. Inflammatory Response
Interventions
  1. Other: predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: admission to ICU

Time: through study completion, an average of 1 year

Secondary Outcomes

Measure: death

Time: through study completion, an average of 1 year
52 Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation

Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are: 1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay: 1. Death 2. Acute Myocardial Infarction [AMI] 3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] 4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation 5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation 2. Similar in terms of major bleeding risk during hospital stay

NCT04408235
Conditions
  1. COVID
  2. Pneumonia, Viral
  3. Coagulation Disorder
Interventions
  1. Drug: Enoxaparin
MeSH:Pneumonia, Viral Pneumonia Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Pneumonia

Primary Outcomes

Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation

Measure: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:

Time: through study completion, up to 30 days

Secondary Outcomes

Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation Improvement of laboratory parameters of disease severity, including: D-dimer level Plasma fibrinogen levels Mean Platelet Volume Lymphocyte/Neutrophil ratio IL-6 plasma levels

Measure: Any of the following events occurring within the hospital stay

Time: through study completion, up to 30 days

Description: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation.

Measure: Mortality at 30 days

Time: 30 days
53 Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis

The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response. The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU

NCT04414293
Conditions
  1. COVID
  2. Pneumonia, Viral
Interventions
  1. Radiation: Lung Low Dose Radiation
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels

Measure: blood oxygen saturation level

Time: 48 hours

Description: radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.

Measure: Torax X-ray

Time: 48 hours

Secondary Outcomes

Description: number of days of hospital stay.

Measure: Hospitalization

Time: 2 months

Description: Number of days free of assisted mechanical respiration.

Measure: days free of assisted mechanical respiration

Time: 3 month

Description: number of deaths

Measure: Mortality

Time: 3 months
54 A Pilot Study to Explore the Efficacy and Safety of Rescue Therapy With Antibodies From Convalescent Patients Obtained With Double-filtration Plasmapheresis (DFPP) and Infused in Patients With Coronavirus Disease 2019 (COVID-19) and Need of Oxygen Support Without Mechanical Ventilation

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.

NCT04418531
Conditions
  1. Pneumonia, Viral
  2. Corona Virus Infection
Interventions
  1. Biological: Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Time to weaning of oxygen support

Time: Through study completion, an average of 3 months

Secondary Outcomes

Measure: Chest XR or CT scan evaluation

Time: Changes during the study up completion, an average of 3 months

Measure: Survival,

Time: Through study completion, an average of 3 months

Measure: Viral titer

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Measure: Anti COVID 19 IgG antibodies

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Measure: Anti COVID 19 IgM antibodies

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: C5a concentration

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: C3a concentration

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum C5b-9 concentration Marker of complement activation

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-6 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-1b levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IFNγ levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum MCP-1 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum TNFα levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-10 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-2 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-7 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.
55 Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

Severe Acute Respiratory Syndrome SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease. Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease. The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

NCT04422613
Conditions
  1. Pneumonia, Viral
Interventions
  1. Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Alteration of the DLCO test defined by a corrected DLCO value <70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)

Measure: Alteration of the DLCO

Time: 4 month

Secondary Outcomes

Description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the values obtained during the diffusing CO / NO test, at 4 month after COVID- 19 pneumonia

Measure: Mechanism of the alteration of gas exchanges

Time: 4 month

Description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during the measurement of lung volumes in respiratory function tests at 4 month after COVID- 19 pneumonia

Measure: Measurement on lung volumes

Time: 4 month

Description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during chest CT-scan at 4 month after COVID- 19 pneumonia

Measure: mechanism of the alteration of gas exchanges by chest scan

Time: 4 month

Description: The mechanism of the alteration of gas exchanges identified will be specified by the analysis of the other values obtained during pulmonary scintigraphy, at 4 month after COVID- 19 pneumonia :

Measure: mechanism of the alteration of gas exchanges by scintigraphy

Time: 4 month

Description: the existence of respiratory symptoms, defined by dyspnea, cough, sputum, haemoptysis, chest pain, sign of right ventricular failure, sleep disorders or a 6-minute walk test value <80% of theoretical, at 4 month after COVID- 19 pneumonia

Measure: Respiratory symptom

Time: 4 month

Description: the existence of persistent bronchial or ventilatory anomalies at 4 months, defined on current respiratory function tests (plethysmography, forced oscillometry test, diaphragmatic explorations, measurement of exhaled NO)

Measure: Bronchial or ventilatory anomalies

Time: 4 month

Description: Persistent respiratory anomalies at 4 months will be evaluated at 12 months of the acute episode by an appropriate paraclinical assessment : mechanism of the alteration of gas exchanges, Respiratory symptom and bronchial or ventilatory anomalies will be evaluated

Measure: Persistent respiratory anomalies

Time: 12 month
56 Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge

In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel. The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.

NCT04422691
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Pulmonary Infection
Interventions
  1. Diagnostic Test: Lung ultrasound
MeSH:Infection Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: 30-day mortality

Measure: Mortality

Time: up to 30 days

Description: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.

Measure: Level-of-care

Time: up to 7 days

Secondary Outcomes

Description: in days

Measure: In-hospital length of stay

Time: Up to 30 days

Measure: Oxygen usage in the emergency department

Time: Within 24 hours

Description: in hours

Measure: Emergency department length of stay

Time: Within 24 hours

Measure: Antibiotics usage

Time: Within 24 hours

Other Outcomes

Description: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.

Measure: Clinical correlation

Time: Within 3 days
57 the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

NCT04424836
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
  3. Acute Respiratory Failure
Interventions
  1. Device: high flow nasal cannula device
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: the mortality rate of patients

Measure: short term mortality

Time: in 28 days.

Description: means the stay day of patients in intensive care unit

Measure: icu stay

Time: up to 28 days

Secondary Outcomes

Description: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg

Measure: blood gases

Time: at the admission time and 24th hour
58 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and Pharmacokinetics of Ibudilast (MN-166) in COVID-19 Subjects at Risk for Developing Acute Respiratory Distress Syndrome

The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and Day 28.

NCT04429555
Conditions
  1. Pneumonia, Viral
Interventions
  1. Drug: Ibudilast
  2. Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 7

Measure: Proportion of subjects free from respiratory failure

Time: 7 days

Description: Mean change from baseline in clinical status based on the NIAID 8-point scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.

Measure: Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 7

Time: 7 days

Description: Percentage of patients with at least a one-point improvement in clinical status using the NIAID 8-point ordinal scale (1= death, 8= not hospitalized, no limitations on activities) at Day 7. A higher score indicates improvement.

Measure: Percentage of patients with improvement in clinical status

Time: 7 days

Description: Mean change from baseline (baseline = 1-fold; any value above 1.0 indicates elevation in cytokine levels; any value below 1.0 indicates reduction in cytokine levels) in migration inhibitory factor (MIF), (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and C-reactive protein (CRP) at Day 7.

Measure: Change in cytokine levels from baseline

Time: 7 days

Secondary Outcomes

Description: Incidence, frequency, and severity of adverse events at Day 7 and Day 14

Measure: Adverse event Incidence, severity, relationship to study drug, and study discontinuations

Time: Days 7, 14

Description: Incidence of out-of-normal-range values and markedly abnormal change from baseline in laboratory safety test variables by treatment group.

Measure: Changes in laboratory values from baseline

Time: 7 days

Description: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14

Measure: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 14

Time: 14 days

Description: Mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 14 and Day 28

Measure: Mean change from baseline in clinical status

Time: Days 14, 28

Description: Proportion of subjects receiving mechanical ventilation or intubation.

Measure: Incidence of mechanical ventilation or intubation

Time: Days 7, 14

Description: Proportion of subjects requiring submission to the intensive care unit

Measure: Intensive care unit admission

Time: 7 days

Description: Blood sample collection to determine plasma concentrations of ibudilast.

Measure: Plasma concentrations of Ibudilast

Time: 7 days

Description: Number of deaths from any cause

Measure: All cause mortality

Time: Days 7, 14, 28
59 SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia

Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.

NCT04435327
Conditions
  1. COVID
  2. Pneumonia, Viral
  3. Barotrauma
  4. Interstitial Lung Disease
  5. Bronchiectasis Adult
  6. Emphysema
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Bronchiectasis Lung Diseases, Interstitial Emphysema Barotrauma
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Bronchiectasis Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Reduction below 80% of predicted values of DLCO

Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)

Time: T1 at 6 months from discharge

Description: Reduction below 80% of predicted values of DLCO

Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)

Time: T2 at 12 months from discharge

Secondary Outcomes

Description: reduction in maximum distance walked

Measure: Alterations in 6 minute walking test (6MWT)

Time: T1 at 6 months from discharge

Description: reduction in maximum distance walked

Measure: Alterations in 6 minute walking test (6MWT)

Time: T2 at 12 months from discharge

Description: reduction in oxygen saturation nadir

Measure: Alterations in 6 minute walking test (6MWT)

Time: T1 at 6 months from discharge

Description: reduction in oxygen saturation nadir

Measure: Alterations in 6 minute walking test (6MWT)

Time: T2 at 12 months from discharge

Description: reduction of Forced Vital Capacity (FVC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Vital Capacity (FVC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Vital Capacity (FVC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Vital Capacity (FVC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Vital Capacity (VC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Total Lung Capacity (TLC, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Total Lung Capacity (TLC, %)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: reduction of Total Lung Capacity (TLC, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of Total Lung Capacity (TLC, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV,%)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Residual Volume (RV, L)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Residual Volume (RV, %)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (absolute value)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (%)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (absolute value)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: increase of Specific Airway Resistance (sRAW) (%)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Motley Index (VR/CPT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T1 at 6 months from discharge

Description: alterations of Tiffeneau Index (IT)

Measure: Alterations of pletismography

Time: T2 at 12 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: reduction of PaO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T1 at 6 months from discharge

Description: alteration of PaCO2 mmHg

Measure: Alterations of Arterial Blood Gas Analysis

Time: T2 at 12 months from discharge

Description: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)

Measure: Abnormal Dyspnea Score

Time: T1 at 6 months from discharge

Description: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)

Measure: Abnormal Dyspnea Score

Time: T2 at 12 months from discharge

Description: Presence and extension of abnormal pulmonary lung sounds at auscultation

Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation

Time: T1 at 6 months from discharge

Description: Presence and extension of abnormal pulmonary lung sounds at auscultation

Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation

Time: T2 at 12 months from discharge

Description: Presence and extension of radiological alterations at chest X-ray

Measure: Presence and extension of radiological alterations at chest X-ray

Time: T1 at 6 months from discharge

Description: Presence and extension of radiological alterations at chest CT scan

Measure: Presence and extension of radiological alterations at chest CT scan

Time: T2 at 12 months from discharge
60 Controlled and Randomized Clinical Trial for Evaluating the Effect of a Supplement of Glycine as Adjuvant in the Treatment of COVID-19 Pneumonia in Patients Initiating Mechanical Ventilation

This study will explore whether a daily supplement of glycine, a substance that has antiinflammatory, cytoprotective, and endothelium-protecting effects, can improve mortality, as well as clinical and biochemical parameters, in patients with severe COVID-19 who initiate mechanical ventilatory support.

NCT04443673
Conditions
  1. COVID-19
  2. SARS-CoV Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS Pneumonia
  5. ARDS, Human
  6. Pneumonia, Viral
Interventions
  1. Dietary Supplement: Glycine
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Adult
HPO:Pneumonia

Primary Outcomes

Description: Number of participants who die divided by number of subjects enrolled in the that study group.

Measure: Mortality

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Secondary Outcomes

Description: Number of days spent under mechanical ventilation.

Measure: Days under mechanical ventilation

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Arterial pressure of oxygen divided by inspired fraction of oxygen.

Measure: PaO2/FiO2 ratio

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Plasma concentration of lactate in arterial blood.

Measure: Arterial plasma lactate

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 1β.

Measure: Serum IL-1β

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 2.

Measure: Serum IL-2

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 4.

Measure: Serum IL-4

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 5.

Measure: Serum IL-5

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 6.

Measure: Serum IL-6

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 7.

Measure: Serum IL-7

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 8.

Measure: Serum IL-8

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 10.

Measure: Serum IL-10

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 12 (p70).

Measure: Serum IL-12

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 13.

Measure: Serum IL-13

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 17A.

Measure: Serum IL-17

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of granulocyte colony stimulating factor.

Measure: Serum G-CSF

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of granulocyte monocyte colony stimulating factor.

Measure: Serum GM-CSF

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interferon gamma.

Measure: Serum IFN-γ

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of monocyte chemoattractant protein 1 (MCAF).

Measure: Serum MCP-1

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of macrophage inflammatory protein 1β

Measure: Serum MIP-1β

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of tumor necrosis factor alpha.

Measure: Serum TNF-α

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of creatinine.

Measure: Serum creatinine

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of alanine aminotransferase. .

Measure: Serum alanine aminotransferase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of aspartate aminotransferase. .

Measure: Serum aspartate aminotransferase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of alkaline phosphatase.

Measure: Serum alkaline phosphatase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of total bilirubin.

Measure: Serum total bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of unconjugated bilirubin.

Measure: Serum unconjugated bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of conjugated bilirubin

Measure: Serum conjugated bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of C reactive protein.

Measure: Serum C reactive protein

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Blood concentration of hemoglobin.

Measure: Hemoglobin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of white blood cells per µl blood.

Measure: Total leukocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of neutrophils per µl blood.

Measure: Neutrophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of lymphocytes per µl blood.

Measure: Lymphocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of monocytes per µl blood.

Measure: Monocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of eosinophils per µl blood.

Measure: Eosinophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of basophils per µl blood.

Measure: Basophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of platelets per µl blood.

Measure: Platelets

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Time that blood takes to clot.

Measure: Prothrombin time

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of plasminogen activator inhibitor 1 (PAI-1).

Measure: Serum PAI-1

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Sequence Organ Failure Assessment (SOFA) score, composed by assessment of PaO2/FiO2 ratio, Glasgow coma scale, mean arterial pressure, bilirubin, and platelets.

Measure: SOFA score

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Acute Physiology And Chronic Health Evaluation II (APACHE II) score, composed by assessment of AaDO2 or PaO2, temperature, mean arterial pressure, pH arterial, heart rate, respiratory rate, sodium, potassium, creatinine, hematocrit, white blood cell count, Glasgow coma scale.

Measure: APACHE II score

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.
61 Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study

During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et al. proposed the combination regimen with azithromycin. However only one study reported the interest of azithromycin alone. Retrospective study reporting the impact of the anti-infective agents used during the pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.

NCT04453501
Conditions
  1. COVID
  2. Pn
  3. Pneumonia, Viral
Interventions
  1. Drug: favorable outcome
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: After being admitted, patient was monitored whether he does not required to be transferred in ICU or died because of a severe COVID-19 pneumonia within 7 days. The outcome was purely clinical. If patient was discharged at home after admission and/or was transferred into a rehabilitation center he was considered as a favorable outcome independently of any biological marker.

Measure: Favorable outcome

Time: Assessed within 7 days after admission

Secondary Outcomes

Description: Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome

Measure: Risk factors 1

Time: Assessed at day 1

Description: Studying if comorbidities were associated with an unfavorable outcome

Measure: Risk factors 2

Time: Assessed at day 1

Description: Studying whether any regimen was associated with a favorable outcome (including azithromycin)

Measure: Interest of anti-infective agents

Time: From date of inclusion until the date of first documented progression to ICU or date of death from any cause, whichever came first, assessed up to 2 months
62 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2

The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04456088
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Corona Virus Infection
Interventions
  1. Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System
  2. Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration as measured by any one of the following: need for non-invasive ventilation need for high flow nasal cannula (HFNC) or need for intubation Death from any cause

Measure: Time to deterioration

Time: up to 14 days

Secondary Outcomes

Description: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air

Measure: Time to stable oxygen saturation

Time: up to 14 days

Other Outcomes

Description: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment

Measure: Treatment Emergent Adverse Events and SAEs

Time: 30 days after last inhalation treatment
63 COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study

Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) . Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.

NCT04474340
Conditions
  1. Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia
  2. Pneumonia, Viral
Interventions
  1. Drug: COVID-19 Convalscent Plasma
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to clinical improvement is defined as a time frame from CCP administration till 30 days or discharge, defined as a 2-grade decrease on an ordinal WHO clinical scale . The WHO clinical scale based on the following 7-grade ordinal levels: 1= ambulatory, independent; 2= ambulatory with assistance; 3=hospitalised, not requiring supplemental oxygen; 4= hospitalised, requiring supplemental oxygen; 5= hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6= hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7= death.

Measure: Time to clinical improvement

Time: 30 days

Secondary Outcomes

Measure: All cause mortality

Time: 30 days
64 A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients

Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).

NCT04476992
Conditions
  1. Hypoxemia
  2. Pneumonia, Viral
  3. Coronavirus Infection
Interventions
  1. Drug: Nitric Oxide-Sessions
  2. Drug: Nitric Oxide-Continuous and Sessions
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Hypoxia
HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.

Measure: Change in Methemoglobin level at 48 hours

Time: 48 hours

Secondary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.

Measure: Change in Methemoglobin level at 96 hours

Time: 96 hours

Description: The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours

Time: 48 hours

Description: The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours

Time: 96 hours

Description: The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.

Measure: Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days

Time: 28 days

Description: The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.

Measure: Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge

Time: 28 days

Description: The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.

Measure: Reduction in the inflammatory markers among groups

Time: 7 days

Description: The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.

Measure: Rate of Acute Kidney Disease (AKI) between groups during hospitalization

Time: 28 days

Description: The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.

Measure: Difference in Katz score between groups

Time: 28 days

Other Outcomes

Description: 1. The exploratory outcome "Effect of nitric oxide on heart function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in heart ultrasound at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in heart ultrasound during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on cardiovascular hemodynamics assessed using cardiac ultrasound in COVID-19 hypoxemic patients

Time: 96 hours

Description: 2. The secondary outcome "Effect of NO gas on lung function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in spirometry at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in spirometry during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on lung function evaluated with serial spirometry in COVID-19 hypoxemic patients

Time: 96 hours
65 Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease

The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die. The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients. To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause. The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.

NCT04479540
Conditions
  1. Pneumonia, Viral
Interventions
  1. Radiation: Angiography scanner
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Pulmonary Embolism Embolism
HPO:Abnormal lung morphology Pneumonia Pulmonary embolism

Primary Outcomes

Description: Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner

Measure: Rate of patients with pulmonary embolism

Time: up to Day 12

Secondary Outcomes

Description: Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Prothrombin level measurement

Time: up to Day 12

Description: Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: activated partial thromboplastin time measurement

Time: up to Day 12

Description: Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Fibrinogen measurement

Time: up to Day 12

Description: Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: D-dimers measurement

Time: up to Day 12

Description: Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Protein C measurement

Time: up to Day 12

Description: Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Willebrand antigen measurement

Time: up to Day 12

Description: Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Soluble tissue factor measurement

Time: up to Day 12

Description: Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Soluble thrombomodulin measurement

Time: up to Day 12

Description: Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: E-selectin measurement

Time: up to Day 12

Description: Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

Measure: Thrombin-antithrombin complex measurement

Time: up to Day 12

Description: Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

Measure: Assessment of clot formation curve

Time: Day 1

Description: Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

Measure: Assessment of thrombin generation

Time: Day 1

Description: Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

Measure: Assessment of fibrinolysis

Time: Day 1

Description: Determine patient mortality

Measure: Mortality

Time: Day 30
66 Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.

The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

NCT04480034
Conditions
  1. Bariatric Surgery Candidate
  2. Covid19
  3. Complication of Surgical Procedure
  4. Pneumonia, Viral
  5. Viral Infection
  6. Obesity, Morbid
  7. Safety Issues
  8. Readmission
Interventions
  1. Procedure: Bariatric procedures
MeSH:Virus Diseases Pneumonia, Viral Pneumonia Obesity Obesity, Morbid
HPO:Obesity Pneumonia

Primary Outcomes

Description: Postbariatric surgery COVID-19 infection, mortality and complications

Measure: Postoperative COVID-19 infection

Time: 30 postoperative days

Secondary Outcomes

Description: Complications, reoperations for any reason related to bariatric surgery.

Measure: Complications related to bariatric surgery

Time: 30 postoperative days
67 Extracellular Vesicle Infusion Treatment for Severe COVID-19

To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.

NCT04493242
Conditions
  1. Covid19
  2. ARDS
  3. Pneumonia, Viral
Interventions
  1. Biological: DB-001
MeSH:Pneumonia, Viral Pneumonia Blister
HPO:Pneumonia

Primary Outcomes

Description: all-cause mortality

Measure: all-cause mortality

Time: 28 days

Description: median days to recovery

Measure: median days to recovery

Time: 28 days
68 A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

The primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.

NCT04513314
Conditions
  1. Covid19
  2. Hyperactive Delirium
  3. Pneumonia, Viral
Interventions
  1. Drug: Valproate
  2. Drug: Quetiapine
  3. Other: Standard of Care
MeSH:Pneumonia, Viral Pneumonia Delirium
HPO:Pneumonia

Primary Outcomes

Description: Richmond Agitation Sedation Scale (RASS) score ranges from +4 (combative) to 0 (alert & calm) to -5 (unarousable).

Measure: Change from baseline RASS score of +3 or greater

Time: Baseline, Day 7

Secondary Outcomes

Description: Total dose of dexmedetomidine administered will be reported from baseline RASS score of +3 or greater.

Measure: Total dose of dexmedetomidine administered

Time: Day 7

Description: Incidence of Treatment Emergent Adverse Events will include: QTc duration > 470 msecs. Increase in Liver Function Tests to a Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Suicidality reported as having a score of moderate or high risk using the Columbia-Suicide Severity Rating Scale Screening (C-SSRS). C-SSRS is a calculated risk assessment tool that scores suicidality from no risk to high risk.

Measure: Incidence of Treatment Emergent Adverse Events

Time: Day 7
69 Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study

The overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (COVID-19) pneumonia.

NCT04517123
Conditions
  1. Covid19
  2. Pneumonia, Viral
Interventions
  1. Other: Prone Positioning
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Participants will be assessed for the occurrence of an escalation in respiratory related care (Yes or No). Escalation in respiratory related care is clinically defined as any of the following: intubation any increase in flow of supplemental oxygen transition to high flow nasal cannula increase in fraction of inspired oxygen transfer from a lower to a higher level acuity of care (e.g. medical floor to intermediate care unit (IMC) or intensive care unit (ICU); IMC to ICU).

Measure: Occurrence of an escalation in respiratory related care (yes vs no)

Time: During hospitalization, up to 30 days

Secondary Outcomes

Description: Oxygen Saturation measured in percent oxygen over a 24-hour period.

Measure: Oxygen Saturation

Time: Over a consecutive 24-hour period after randomization

Description: Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period.

Measure: Respiratory Effort as assessed by Respiratory Rate

Time: Over a consecutive 24-hour period after randomization
70 Toclizumam Versus Dexamethasone in Severe Covid-19 Cases

randomized controlled trial comparing survival benefit of Tocilizumab therapy with dexamethasone in patients with severe COVID 19

NCT04519385
Conditions
  1. Pneumonia, Viral
Interventions
  1. Drug: Tocilizumab
  2. Drug: Dexamethasone
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: survival 14 days from admission date

Measure: Proportion of participants with Overall Survival at 14 days

Time: 14 days

Secondary Outcomes

Description: Change in Fio2/Pao2

Measure: Fio2/Pao2

Time: 2 days
71 Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design

SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.

NCT04528888
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Pneumonia, Viral
  4. Coagulopathy
Interventions
  1. Drug: Enoxaparin
  2. Drug: Methylprednisolone
  3. Drug: unfractionated heparin
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.

Measure: All-cause mortality at day 28

Time: Day 28 from randomization

Secondary Outcomes

Description: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.

Measure: All-cause mortality at ICU discharge

Time: from randomization to ICU discharge, censored at day 30

Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge

Measure: All-cause mortality at hospital discharge

Time: from randomization to ICU discharge, censored at day 90

Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs

Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.

Measure: New organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.

Measure: Grade of organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.

Measure: ICU free days at day 28

Time: From randomization to day 28

Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus

Measure: Occurrence of new infections

Time: from randomization to day 28

Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.

Measure: Ventilation free days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.

Measure: Vasopressors free-days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Occurrence of switch from non-invasive to invasive mechanical ventilation

Measure: Switch from non-invasive to invasive mechanical ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation

Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.

Measure: Occurrence of protocol related adverse events

Time: From randomization to day 28

Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction

Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)

Measure: Occurrence of major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.

Measure: Occurrence of clinically relevant non-major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Other Outcomes

Description: Mean arterial pressure will be measured in millimeters of mercury

Measure: Mean arterial pressure

Time: Daily from inclusion until ICU discharge, censored day 28

Description: hearth rate will be measured in beats per minute

Measure: hearth rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: respiratory rate will be measured in breaths per minute

Measure: respiratory rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours

Measure: diuresis

Time: Daily from inclusion until ICU discharge, censored day 28

Description: systemic body temperature will be measured in celsius degrees

Measure: systemic body temperature

Time: Daily from inclusion until ICU discharge, censored day 28

Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours

Measure: fluid balance

Time: Daily from inclusion until ICU discharge, censored day 28

Description: Haemoglobin will be measured in mg/dl

Measure: Haemoglobin concentration

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: platelets count will be measured in U 10^3/mm^3

Measure: platelets count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: white blood cells count will be measured in U per 10^9/L

Measure: white blood cells count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: troponin will be measured in µg/L

Measure: troponin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: coagulative function will be measured with parameters INR, PT, aPTT

Measure: coagulative function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: D-dimer will be measured in µg/ml

Measure: D-dimer

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: anti-thrombin will be measured as a percentage

Measure: anti-thrombin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: liver function will be assessed through measurement of AST, ALT in U/L

Measure: Liver function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Bilirubin will be measured in mg/dL

Measure: Bilirubin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Creatinine will be measured in mg/dL

Measure: Creatinine

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Blood cells count will be measured in Units per x 10^9/L of blood

Measure: Blood cells count

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: C-reactive protein (CRP) will be measured in mg/dl

Measure: C-reactive protein (CRP)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: procalcitonin(PCT) wiull be measured in ng/ml

Measure: procalcitonin(PCT)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: interleukin 6 (IL-6) will be measured in pg/ml

Measure: interleukin 6 (IL-6)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation

Measure: Ventilation mode

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air

Measure: inspired oxygen fraction

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis

Measure: Gas exchanges

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: lactates will be measured in mMol/L

Measure: lactates

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: pH will be measured in pH scale

Measure: pH

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values

Measure: oxygen saturation in blood

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: New blood, respiratory and urinary-tract infections will be recorded

Measure: New infections

Time: From randomization to day 28

Description: Viral reactivation measured by CMV DNA titres will be recorded.

Measure: Viral reactivation

Time: From randomization to day 28

Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.

Measure: Need of new renal replacement therapy

Time: from randomization to day 28

Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded

Measure: Adjunctive treatments

Time: from randomization to ICU discharge (censored at day 28);
72 A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia

Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia

NCT04550325
Conditions
  1. Covid19
  2. Pneumonia, Viral
Interventions
  1. Biological: Kamada Anti-SARS-CoV-2
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Record adverse events, serious adverse events, and deaths

Measure: Adverse events, serious adverse events, and deaths

Time: 14 days

Description: Record adverse events, serious adverse events, and deaths

Measure: Adverse events, serious adverse events, and deaths

Time: 28 days

Secondary Outcomes

Description: Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin

Measure: AUC0-7 of Anti SARS CoV-2 antibodies

Time: 7 days

Description: Evaluate virus neutralization activity of patient's plasma

Measure: Neutralization activity

Time: 7 days

Other Outcomes

Description: Time patient spent in hospital

Measure: Duration of Hospitalization

Time: 84 days

Description: Score on the 6 point ordinate scale

Measure: Clinical status on the 6 point ordinate scale

Time: 84 days
73 Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.

NCT04561219
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Pneumonia, Viral
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage.

Measure: Orotracheal intubation rate

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed free of mechanical ventilation, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Mechanical ventilation free days

Time: 14 days

Secondary Outcomes

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Hospitalisation days

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: ICU days

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Intranasal oxygen support days

Time: 14 days

Description: Compare the mortality rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Mortality rate

Time: 14 days

Description: Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with fever

Time: 14 days

Description: Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with cough

Time: 14 days

Description: Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with dyspnea

Time: 14 days

Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.

Measure: Radiologic findings

Time: Day1

Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.

Measure: Radiologic findings

Time: Day7

Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.

Measure: Cardiologic findings

Time: Day1

Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.

Measure: Cardiologic findings

Time: Day7

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein - absolute number

Time: Day 1

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein serum levels

Time: Day 3

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein serum levels

Time: Day 7

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 1

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 3

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 7

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 1

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 3

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 7

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 1

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 3

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 7

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 1

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 3

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 7

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 1

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 3

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 7

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 1

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 3

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 7

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 1

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 3

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 7

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 1

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 3

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 7

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 1

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 3

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 7

Description: To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Blood cell count

Time: 7 days

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 1

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 3

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 7

Other Outcomes

Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage.

Measure: Adverse events - percentage

Time: Day 14

Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number.

Measure: Adverse events - absolute number

Time: Day 14

Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.

Measure: Treatment discontinuation rate - absolute number

Time: Day 14

Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.

Measure: Treatment discontinuation rate - percentage

Time: Day 14
74 Open Clinical Trial of the Use of Antioxidants and Pentoxifylline as Adjuvant Therapy to Standard Therapy in Patients With and Without Septic Shock Secondary to COVID-19 Severe Pneumonia

Introduction: SARS-CoV2 infection produces severe pneumonia with pulmonary alveolar collapse. There is no specific treatment to date. In experimental models and humans with septic shock, there is a high production of nitric oxide (NO) and reactive nitrogen species (RNS) and can cause multiple organ failure. The administration of antioxidants such as n-acetylcysteine (NAC), vitamin C, melatonin, and vitamin E participate in increasing the intracellular content of GSH, ROS sequestration, protection of the lipids of cell membranes, cytosol proteins, nuclear DNA, mitochondrial and decrease LPO. Justification: as there is no specific antiviral therapy, the therapeutic options are limited, complications and mortality are high; It is intended to evaluate the effect of antioxidants on the storm outcome of the dysregulation of oxidative stress. Hypothesis: It is postulated that adjuvant therapy with antioxidants and Pentoxifylline reduces the use of ventilators in patients with or without septic shock secondary to severe SARS-COV2 pneumonia as decreases lipoperoxidation, and corrects dysregulation of oxidative stress by increasing the antioxidant capacity. Objectives: To evaluate whether it is possible to avoid intubation or decrease assisted mechanical ventilation days, improve oxidative stress dysregulation in patients with SARS-COV2 infection with severe pneumonia with or without septic shock. Methodology: Quasi-experimental, open analytical, prospective, and longitudinal study (before-after). In patients over 18 years of age who are admitted to the CITIBANAMEX Center with or without septic shock secondary to severe SARS-COV2 pneumonia. There will be two groups: 1) patients without septic shock and 2) patients with septic shock secondary to severe pneumonia due to SARS-COV2. A single antioxidant will be applied following the clinical decision tree (NAC, Vit C, Vit E, melatonin) more Pentoxifylline orally or by orogastric tube for a total of 5 days from the start of the protocol. APACHE II will calculate the risk, SOFA, MEXSOFA, measurements of IL-8, vitamin C, NO3 / NO2, LOP, total antioxidant capacity will be carried out at baseline and 48 hours. SOFA will be calculated for seven days, in addition to days of hospitalization, days of mechanical ventilation. It was evaluated 28 days after discharge by telephone.

NCT04570254
Conditions
  1. Pneumonia, Viral
  2. Covid19
  3. ARDS
  4. Oxidative Stress
Interventions
  1. Drug: Vitamin C
  2. Drug: Vitamin E
  3. Drug: Melatonin
  4. Drug: N-acetyl cysteine
  5. Drug: Pentoxifylline
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: It will be evaluated whether secondary to SARS-COV2 pneumonia, the outcome of the patient is dead.

Measure: Death from any cause

Time: From admission to discharge, up to 30 days.

Description: The percentage of patients with SARS-COV2 pneumonia in whom orotracheal intubation was avoided will be evaluated.

Measure: Percentage of patients who required orotracheal intubation

Time: From admission to discharge, up to 1 week

Description: It will be evaluated if it is possible to reduce the days of mechanical ventilation

Measure: Assisted mechanical ventilation

Time: From admission to discharge, up to 1 week

Description: The number of days of stay in the intensive care unit will be evaluated.

Measure: Stay in an intensive care unit

Time: From admission to discharge, up to 1 week

Secondary Outcomes

Description: For the measurement of lipid peroxidation, 50 µL of CH3-OH with 4% BHT plus a phosphate buffer pH 7.4 was added to 100 µL of plasma. The mixture was vigorously vortexed for 5 seconds and subsequently incubated in a water bath at 37 ° C for 30 minutes. 1.5 mL of 0.8 M tribarbituric acid was added to the sample, which was incubated in a water bath with boiling temperature for one hour. After this time and to stop the reaction, the sample was placed on ice; 1 mL 5% KCl was added to each sample, as was 4 mL of n-butanol; The sample was vortexed for 30 seconds and centrifuged at 4000 rpm at room temperature for 2 min. Subsequently, the butanol phase was extracted, and the absorbance at 532 nm was measured. The calibration curve was obtained using tetra ethoxy propane as a standard.

Measure: Measure lipoperoxidation in basal and post-therapy samples

Time: Baseline and 5 days post-dose

Description: 100 mL of plasma was suspended in 1.5 mL of a reaction mixture prepared as follows: 300 mM of acetate buffer with pH 3.6, 20 mM of ferric chloride hexahydrate, and 10 mM of 2,4,6-Tris-2- Pyridyl-s-triazine dissolved in 40 mM hydrochloric acid in a ratio 10: 1: 1 v / v, respectively. The mixture was vigorously vortexed for 5 seconds. It was incubated at 37 ° C for 15 min in the dark. The absorbance was measured at 593 nm. The calibration curve was obtained using Trolox

Measure: Evaluation of the total antioxidant capacity

Time: Baseline and 5 days post-dose

Description: For the measurement of NO3- / NO2-, 100 µl of plasma were added 100 µL of a 10% solution of ZnSO4, 100 µL of 0.5 N NaOH and 700 µl of tridestated water. It was shaken vigorously and centrifuged at 10,000 rpm for 5 minutes. To the resulting supernatant, Griess reagent (200 µL of 1% sulfanilamide and 200 µL of 1% N- (1-naphthyl) ethylenediamine hydrochloride) was added and incubated for 10 min protected from light at room temperature. The coloration developed after incubation was measured at an analytical wavelength of 540 nm in a double beam UV-Vis spectrometer (DW2000, SLM-Aminco, Urbana, Illinois, USA). The calibration curve was performed with a KNO3 stock solution (Spectrum Quality Products, Inc., Gardena CA) in a concentration range from 0.001 nM to 10 nM.

Measure: Oxidative and antioxidant stress

Time: Baseline and 5 days post-dose

Description: Measurements will be made using the Sequential Organ Failure Assessment (SOFA) every 24 hours. With a minimum score of 0-1 which translates a mortality in initial score and the highest of 0%. The maximum score of more than 14 translates a mortality of 95.2% in the initial evaluation and 89.7% in the highest evaluation.

Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2

Time: From day 0 to day 7 post antioxidant dose.

Description: Measurements will be made using the Mexico Sequential Organ Failure Assessment (MEXSOFA) every 24 hours. highest evaluation. Patients with an initial MEXSOFA score of 9 points or less calculated during the first 24 hours after admission to the ICU had a mortality rate of 14.8%, while those with an initial MEXSOFA score of 10 points or more had a mortality rate. 40% mortality rate. The MEXSOFA score at 48 h was also associated with mortality: patients with a score of 9 points or less had a mortality rate of 14.1%, while those with a score of 10 points or more had a rate of 50% mortality.

Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2

Time: From day 0 to day 7 post antioxidant dose.
75 Risk Factors, Prognosis and Findings by Computed Tomography in Patients Infected by COVID-19 and Its Association With Severity.

In the SARS-CoV2 pandemic, imaging studies proved its diagnostic utility to determine the severity of lung involvement. Computed tomography (CT) is a state-of-the-art study proven to be a highly sensitive diagnostic test complemented by RT-PCR testing to determine the disease and the degree of severity. In March 2020, the Dutch Society of Radiology developed a standardized assessment scheme for COVID-19 lung disease, called CO-RADS. This system proposes a level of suspicion of pulmonary involvement of COVID-19, based on the simple chest tomography findings. The level of suspicion ranges from very low (CO-RADS 1) to very high (CO-RADS 5), with two additional categories involving a technically deficient study (CO-RADS 0) and a positive RT-PCR test for SARS -CoV-2 known before tomography (CO-RADS 6). For its part, acute respiratory damage secondary to SARS-COV2 pneumonia causes acute respiratory distress syndrome, which warrants immediate medical attention. During the evaluation and triage of patients with suspected or confirmed SARS-COV2 infection, it is a challenge for health personnel given that the severity and clinical presentation is highly variable. The patient's risk stratification is carried out using previously established and validated risk scales and is a fundamental tool for making clinical decisions. Some of the risk indices and scales have been developed and used in the pandemic epicenters, such as China and Europe. Useful for the clinician is the national early warning scale (NEWS 2), severe disease risk assessment score (COVID-GRAM), the rapid severity index for COVID-19 (qCSI), evaluation score of Modified sequential organ failure (mSOFA), the sepsis-induced coagulopathy score (SIC), the ROX index as a predictor of success to the high-flow nasal cannula. The evaluation of the risk of thrombotic complications such as the Padua risk, of cardiac complications such as QT segment prolongation, through the Tisdale risk score. Risk stratification is essential in the current COVID-19 pandemic situation; upon admission, the clinician will discern if the patient requires in-hospital medical treatment, the risk of severe disease, and progression to assisted mechanical ventilation. This work aims to establish whether the severity of the findings identified by cardiac tomography upon admission and the risk established by the different established prognostic indices.

NCT04577105
Conditions
  1. Covid19
  2. ARDS
  3. Pneumonia, Viral
  4. Computed Tomography
Interventions
  1. Diagnostic Test: Simple chest tomography
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: CO-RADS will categorize the level of suspicion of COVID-19. Very low (CO-RADS 1) to very high (CO-RADS 5), with two additional categories involving a technically deficient study (CO-RADS 0) and a positive RT-PCR test for SARS-CoV- 2 known before tomography (CO-RADS 6).

Measure: Assessment of the level of suspicion of SARS-CoV2 infection

Time: At hospital admission

Description: It will be a semi-quantitative assessment of lung lobe lesions' extent considering five lobes (upper right lobes, middle lobe, lower right lobe, upper left lobe, and lower left lobe). Each of these lobes, depending on their condition, is scored from 1 to 5, with 1 <5%, 2 from 5 to 25%, 3> 25 to 50%, 4 from> 50 to 75% and the number 5 greater than 75%. With this, it is grouped into mild affection from 1 to 5 points, moderate from 5 to 15 points, and greater than 15 points as severe affection

Measure: Evaluate the severity degree of pulmonary affection by chest computed tomography

Time: At hospital admission

Description: The requirement for orotracheal intubation and the start of assisted mechanical ventilation after admission will be evaluated

Measure: Percentage of patients requiring endotracheal intubation

Time: From admission to discharge, up to 1 week

Description: Patients who present fatal descent during hospitalization will be evaluated.

Measure: Death from any cause

Time: From admission to discharge, up to 1 week

Secondary Outcomes

Description: The evaluation of multiple organ failure secondary to sepsis will be carried out using the mSOFA scale, which can predict in-hospital mortality and 30 days, with a minimum score of 0-7 that translates mortality of 0% and a score greater than 11 translates mortality of 58%.

Measure: Modified Sequential Organ Failure Assessment (mSOFA)

Time: At hospital admission

Description: The sepsis-induced coagulopathy score scale (SIC) refers to the diagnosis of coagulopathy when the score is greater than 4 or the INR is greater than or equal to 3.

Measure: Sepsis-induced coagulopathy (SIC)

Time: At hospital admission

Description: A score of 0-4 confers a low risk; on the contrary, a score of more than 7 gives a high risk.

Measure: National Early Warning Scale (NEWS 2)

Time: At hospital admission

Description: It establishes three risk groups: the mild one with a risk of critical illness of less than 1.7% and the high risk of more than 40.4%.

Measure: COVID-GRAM severe illness risk score

Time: At hospital admission

Description: A score less than or equal to 3 gives a low risk with a critical illness risk of 4%, while a score of 10-12 gives a high risk and a critical illness probability of 57%.

Measure: Rapid Severity Index for COVID-19 (qCSI)

Time: At hospital admission

Description: A ratio of 6-8 translates mild physiological stress, while a ratio of more than 18 a severe physiological stress level.

Measure: Neutrophil-Lymphocyte Ratio (NLR)

Time: At hospital admission

Description: The gradient Aa O2 = [(FiO2) × (Atmospheric pressure - Pressure of H2O) - (PaCO2 / 0.8)] - PaO2 of ABG is calculated and a normal gradient with age is estimated with the following formula: Estimate of normal gradient = (Age / 4) + 4. The gradient is increased in conditions such as ARDS, PE, and cardiac failure.

Measure: Alveolar-arterial gradient of oxygen

Time: At hospital admission

Description: Required criteria (must have all three of the following): Timing within 1 week of clinical insult or new/worsening respiratory symptoms, Chest XR shows bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules Respiratory failure not fully explained by cardiac failure/fluid overload Risk factor (one of the following): Risk factor for ARDS present (e.g. pneumonia, trauma, sepsis, pancreatitis). Objective assessment (Echo) excludes hydrostatic edema. Severity (based on oxygenation, select one of the following): Mild: PaO₂/FiO₂ >200 to ≤300 mmHg with PEEP OR CPAP ≥5 cm H₂O, Moderate: PaO₂/FiO₂ >100 to ≤200 mmHg with PEEP ≥5 cm H₂O and Severe: PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O

Measure: Berlin Criteria for Acute Respiratory Distress Syndrome

Time: At hospital admission
76 Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia

The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia

NCT04606407
Conditions
  1. Viral Pneumonia
  2. Nitric Oxide
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Inhaled Nitric Oxide
  6. Covid19
  7. SARS-CoV Infection
Interventions
  1. Device: LungFit™
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Measure: incidence of Serious Adverse Events

Time: 30 days

Secondary Outcomes

Description: Time to fever resolution

Measure: fever resolution

Time: Baseline to 30 days

Description: Number of patients requiring admission to ICU

Measure: ICU admission

Time: Baseline to 30 days

Description: Time until patient no longer requires supportive oxygen

Measure: Oxygen support

Time: Baseline to 30 days

Description: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Measure: Stable room air saturation

Time: Baseline to 30 days
77 Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia. The secondary objectives are to describe and compare between groups: - The number of days without mechanical ventilation - The need for mechanical ventilation - 28-day mortality - Progression towards acute respiratory distress syndrome (ARDS) - Change in the qSOFA score - Length of hospitalization - The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if

NCT04619693
Conditions
  1. Pneumonia, Viral
  2. SARS-Cov-2
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Treatment failure is defined as the need to transfer the patient to intensive care for mechanical ventilation.

Measure: Treatment failure (yes/no)

Time: Hospital discharge (expected maximum of 28 days)

Secondary Outcomes

Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

Measure: Human Plasma BAK-125 proteomics profile

Time: Baseline (day 0)

Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

Measure: Human Plasma BAK-125 proteomics profile

Time: Day 7

Measure: Circulating blood interferon level

Time: Baseline (day 0)

Measure: Circulating blood interferon level

Time: Day 7

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of SpO2

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of FiO2

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of temperature (°C)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of respiratory rate (cycles per minute)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of pulse (bpm)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of systolic blood pressure (mmHg)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of diastolic blood pressure (mmHg)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: Capillary glycemia will be measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of capillary glycemia (g/L)

Time: Throughout initial hospitalization (expected maximum of 28 days)

Description: The Quick Sequential Organ Failure Assessment (qSOFA) score will be assessed at least twice per day throughout the initial hospitalization period. The quick Sepsis-related organ failure assessment (qSOFA) score ranges from 0 to 3 points, with '3' indicating the worst health state. It uses three criteria, assigning one point for low blood pressure (systolic blood pressure ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation.

Measure: A vector of repeated measures of the qSOFA score

Time: Throughout initial hospitalization (expected maximum of 28 days)

Measure: Hemoglobin

Time: Baseline (day 0)

Measure: Hemoglobin

Time: Day 2

Measure: Hemoglobin

Time: Day 4

Measure: Hemoglobin

Time: Day 7 (or day of discharge if before day 7)

Measure: Platelet count

Time: Baseline (day 0)

Measure: Platelet count

Time: Day 2

Measure: Platelet count

Time: Day 4

Measure: Platelet count

Time: Day 7 (or day of discharge if before day 7)

Measure: White blood cell count

Time: Baseline (day 0)

Measure: White blood cell count

Time: Day 2

Measure: White blood cell count

Time: Day 4

Measure: White blood cell count

Time: Day 7 (or day of discharge if before day 7)

Measure: Neutrophil percentage

Time: Baseline (day 0)

Measure: Neutrophil percentage

Time: Day 2

Measure: Neutrophil percentage

Time: Day 4

Measure: Neutrophil percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Eosinophil percentage

Time: Baseline (day 0)

Measure: Eosinophil percentage

Time: Day 2

Measure: Eosinophil percentage

Time: Day 4

Measure: Eosinophil percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Basophil percentage

Time: Baseline (day 0)

Measure: Basophil percentage

Time: Day 2

Measure: Basophil percentage

Time: Day 4

Measure: Basophil percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Lymphocyte percentage

Time: Baseline (day 0)

Measure: Lymphocyte percentage

Time: Day 2

Measure: Lymphocyte percentage

Time: Day 4

Measure: Lymphocyte percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Monocyte percentage

Time: Baseline (day 0)

Measure: Monocyte percentage

Time: Day 2

Measure: Monocyte percentage

Time: Day 4

Measure: Monocyte percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Prothrombin rate (%)

Time: Baseline (day 0)

Measure: Prothrombin rate (%)

Time: Day 2

Measure: Prothrombin rate (%)

Time: Day 4

Measure: Prothrombin rate (%)

Time: Day 7 (or day of discharge if before day 7)

Measure: Activated partial thromboplastin time ratio

Time: Baseline (Day 0)

Measure: Activated partial thromboplastin time ratio

Time: Day 2

Measure: Activated partial thromboplastin time ratio

Time: Day 4

Measure: Activated partial thromboplastin time ratio

Time: Day 7 (or day of discharge if before day 7)

Measure: Fibrinogen (g/L)

Time: Baseline (Day 0)

Measure: Fibrinogen (g/L)

Time: Day 2

Measure: Fibrinogen (g/L)

Time: Day 4

Measure: Fibrinogen (g/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: D-Dimers (μg/mL)

Time: Baseline (Day 0)

Measure: D-Dimers (μg/mL)

Time: Day 2

Measure: D-Dimers (μg/mL)

Time: Day 4

Measure: D-Dimers (μg/mL)

Time: Day 7 (or day of discharge if before day 7)

Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Baseline (Day 0)

Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 2

Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 4

Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Baseline (Day 0)

Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 2

Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 4

Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Glucose (mmol/L)

Time: Baseline (Day 0)

Measure: Glucose (mmol/L)

Time: Day 2

Measure: Glucose (mmol/L)

Time: Day 4

Measure: Glucose (mmol/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Glycated haemoglobin (HbA1c; %)

Time: Baseline (Day 0)

Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 2

Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 4

Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 7 (or day of discharge if before day 7)

Measure: Urea (mmol/L)

Time: Baseline (Day 0)

Measure: Urea (mmol/L)

Time: Day 2

Measure: Urea (mmol/L)

Time: Day 4

Measure: Urea (mmol/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Creatinine (µmol/L)

Time: Baseline (Day 0)

Measure: Creatinine (µmol/L)

Time: Day 2

Measure: Creatinine (µmol/L)

Time: Day 4

Measure: Creatinine (µmol/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Baseline (Day 0)

Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 2

Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 4

Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 7 (or day of discharge if before day 7)

Measure: Albumin (g/L)

Time: Baseline (Day 0)

Measure: Albumin (g/L)

Time: Day 2

Measure: Albumin (g/L)

Time: Day 4

Measure: Albumin (g/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: C reactive protein (CRP, mg/L)

Time: Baseline (Day 0)

Measure: C reactive protein (CRP, mg/L)

Time: Day 2

Measure: C reactive protein (CRP, mg/L)

Time: Day 4

Measure: C reactive protein (CRP, mg/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Baseline (Day 0)

Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 2

Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 4

Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Hypersensitive troponin T (µg/L)

Time: Baseline (Day 0)

Measure: Hypersensitive troponin T (µg/L)

Time: Day 2

Measure: Hypersensitive troponin T (µg/L)

Time: Day 4

Measure: Hypersensitive troponin T (µg/L)

Time: Day 7 (or day of discharge if before day 7)

Measure: Ferritin (µg/L)

Time: Baseline (Day 0)

Measure: Ferritin (µg/L)

Time: Day 2

Measure: Ferritin (µg/L)

Time: Day 4

Measure: Ferritin (µg/L)

Time: Day 7 (or day of discharge if before day 7)

Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Baseline (Day 0)

Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 2

Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 4

Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 7 (or day of discharge if before day 7)

Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Baseline (Day 0)

Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 2

Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 4

Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 7 (or day of discharge if before day 7)

Measure: Natural killer cell count

Time: Baseline (Day 0)

Measure: Natural killer cell count

Time: Day 2

Measure: Natural killer cell count

Time: Day 4

Measure: Natural killer cell count

Time: Day 7 (or day of discharge if before day 7)

Measure: Activated T cell percentage

Time: Baseline (Day 0)

Measure: Activated T cell percentage

Time: Day 2

Measure: Activated T cell percentage

Time: Day 4

Measure: Activated T cell percentage

Time: Day 7 (or day of discharge if before day 7)

Measure: Change in SARS-CoV-2 real-time polymerase chain reaction cycle threshold

Time: Baseline to day 7 (or day of discharge if before day 7)

Measure: Change in SARS-CoV-2 IgG serology (% of control signal = PCS)

Time: Baseline to day 7 (or day of discharge if before day 7)

Measure: Change in SARS-CoV-2 IgM serology (% of control signal = PCS)

Time: Baseline to day 7 (or day of discharge if before day 7)

Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 real time polymerase chain reaction

Time: Day 7 (or day of discharge if before day 7)

Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgG serology

Time: Day 7 (or day of discharge if before day 7)

Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgM serology

Time: Day 7 (or day of discharge if before day 7)

Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for grand glass opacities

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for consolidation

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for total lesions

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

Measure: Requirement for low flow oxygen therapy during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Requirement for high flow oxygen therapy during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Requirement for non-invasive ventilation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Requirement for invasive ventilation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Requirement for dialysis during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Requirement for extracorporeal membrane oxygenation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Classification of acute respiratory distress syndrome (ARDS) according to the Berlin criteria during initial hospitalization: absent, mild, moderate or severe

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Length of stay (hours) in intensive care

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Length of stay (hours) in hospital

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Days alive and without low flow oxygen therapy

Time: Day 28

Measure: Days alive and without high flow oxygen therapy

Time: Day 28

Measure: Days alive and without any oxygen therapy

Time: Day 28

Measure: Days alive and without non-invasive ventilation

Time: Day 28

Measure: Days alive and without invasive ventilation

Time: Day 28

Measure: Days alive and without extracorporeal membrane oxygenation

Time: Day 28

Measure: Days alive and without intensive care

Time: Day 28

Measure: Days alive and without hospitalisation

Time: Day 28

Measure: Mortality

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Mortality

Time: Day 28

Measure: Club cell secrectory protein polymorphism A38G

Time: Between day 0 and day 28

Other Outcomes

Measure: Presence/absence of incident hyperglycemia during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Presence/absence of secondary infection during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Presence/absence of cardiovascular event (ischemic, stroke, other) during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Presence/absence of digestive hemorrhage during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Presence/absence of neuro-psychiatric event (acute delirium, depressive syndrome, decompensation of an underlying psychiatric pathology) during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Adverse events

Time: Day of hospital discharge (expected maximum of 28 days)

Measure: Adverse events

Time: Day 28
78 Epidemiological and Clinical Characteristics of COVID-19 Patients in Kazakhstan in Early 2020: a Retrospective, Observational Cohort Study

The aim of this study is to assess the epidemiological and clinical features of patients diagnosed with COVID-19 in Kazakhstan at the onset of the pandemic.

NCT04627194
Conditions
  1. Covid19
  2. Pneumonia, Viral
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Risk factors associated with disease severity and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.

Measure: Clinical and demographic predictors of disease severity among hospitalized COVID-19 patients.

Time: approximately 70 days

Description: Risk factors associated with death and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.

Measure: Clinical and demographic predictors of mortality among hospitalized COVID-19 patients.

Time: approximately 70 days
79 Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

The study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

NCT04629703
Conditions
  1. Covid19
  2. SARS (Severe Acute Respiratory Syndrome)
  3. SARS Pneumonia
  4. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  5. Pneumonia
  6. Pneumonia, Viral
Interventions
  1. Drug: Fostamatinib
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Progression to severe/critical disease within 29 days of first dose of study treatment

Measure: Progression to severe/critical disease within 29 days of first dose of study treatment

Time: 29 days

Secondary Outcomes

Description: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29

Measure: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29

Time: 29 days

Description: Total number of calendar days hospitalized through Day 29

Measure: Total number of calendar days hospitalized through Day 29

Time: 29 days
80 Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial)

Low-dose glucocorticoid treatment is the only intervention shown to significantly reduce mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. In particular, a large UK randomized controlled trial (RECOVERY trial) demonstrated the efficacy of dexamethasone at a dosage of 6mg/day for 10 days in reducing mortality compared to usual therapy, with a greater impact on patients requiring mechanical ventilation (36% reduction) or oxygen therapy (18% reduction) than on those who did not need respiratory support (doi: 10.1056/NEJMoa2021436). However, there is still paucity of information guiding glucocorticoid administration in severe pneumonia/ARDS and no evidence of the superiority of a steroid drug -nor of a therapeutic scheme- compared to the others, which led to a great heterogeneity of treatment protocols and misinterpretation of available findings. In a recent longitudinal observational study conducted in Italian respiratory high-dependency units, a protocol with prolonged low-dose methylprednisolone demonstrated a 71% reduction in mortality and the achievement of other secondary endpoints such as an increase in ventilation-free days by study day 28 in a subgroup of patients with severe pneumonia and high levels of systemic inflammation (doi: 10.1093/ofid/ofaa421). The treatment was well tolerated and did not affect viral shedding from the airways. In light of these data, the present study aims to compare the efficacy of a methylprednisolone protocol and that of a dexamethasone protocol based on previous evidence in increasing survival by day 28, as well as in reducing the need and duration for mechanical ventilation, among hospitalized patients requiring noninvasive respiratory support (oxygen supplementation and/or noninvasive ventilation).

NCT04636671
Conditions
  1. Covid19
  2. Viral Pneumonia Human Coronavirus
  3. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Methylprednisolone
  2. Drug: Dexamethasone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Survival proportion at 28 days in both arms

Measure: Survival

Time: 28 days

Secondary Outcomes

Description: Number of days free from mechanical ventilation (either noninvasive or invasive) by study day 28 in both arms

Measure: Reduction in the need for mechanical ventilation

Time: 28 days

Description: Number of days of hospitalization for patients discharged alive in both arms

Measure: Length of hospitalization

Time: From date of randomization until the date of hospital discharge, assessed up to 60 days

Description: Proportion of patients requiring tracheostomy in both arms

Measure: Need for tracheostomy

Time: Day 28

Description: C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms

Measure: Reduction in systemic inflammation markers

Time: Day 3, 7 and 14

Description: PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms

Measure: Amelioration of oxygenation

Time: Day 3, 7 and 14

Description: WHO clinical progression scale at study day 3, 7 and 14 in both arms

Measure: Disease progression

Time: Day 3, 7 and 14
81 Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study

This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course

NCT04644302
Conditions
  1. Viral Pneumonia
  2. Sepsis
Interventions
  1. Diagnostic Test: microcirculation recording
MeSH:Sepsis Toxemia Pneumonia, Viral Pneumonia
HPO:Pneumonia Sepsis

Primary Outcomes

Description: PPV describes microcirculation dysfunction

Measure: change in Proportion of Perfused Vessels (PPV) parameter

Time: 1st, 2nd and 3rd day

Description: Syndecan-1 is a marker of endothelial glycocalyx

Measure: change in Syndecan-1 serum concentration

Time: 1st, 2nd and 3rd day

Secondary Outcomes

Description: albuminuria is a marker of glomerular endothelial cells dysfunction

Measure: change in albuminuria

Time: 1st, 2nd and 3rd day

Description: mortality in 28 days from ICU admission

Measure: mortality in 28 days

Time: 30 days
82 A Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP, an Alpha-1 Antitrypsin Infusion Therapy With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection

This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.

NCT04675086
Conditions
  1. Covid19
  2. Pneumonia, Viral
Interventions
  1. Drug: alpha1-proteinase inhibitor
  2. Drug: Antiviral Agents
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Duration of new non-invasive ventilation or high flow oxygen use (measured by days)

Time: 365 Days

Secondary Outcomes

Measure: Clinical status on a 7-point ordinal scale (from 1=death to 7=not hospitalized

Time: 1 Year

Measure: The percentage change in cytokine levels from screening through day 10, Day 17 and Day 24

Time: 10 Days, 17 Days, & 24 Days

Measure: The percentage change in oxygen requirements including PEEP and FiO2 from screening through day 10.

Time: 10 Days

Measure: The percentage of subjects that required mechanical ventilation during the treatment period.

Time: 1 Year

Measure: The percent of patients with a SOFA score between 0-6 during treatment period.

Time: 1 Year

Measure: The percent of mortality during the treatment period.

Time: 1 Year

Measure: Evaluate the need, dosage and duration of vasopressors (number of days and average daily dose).

Time: 1 Year

Measure: Number of Days fever free (defined by temperature of <100°F (oral) for 24 hours)

Time: 1 Year

Measure: To evaluate the average number of days in the ICU

Time: 1 Year

Measure: To evaluate the average number of days in the hospital

Time: 1 Year

Measure: To evaluate the number of days with a PO2/FiO2 <300 or other parameters decided on with oxygen

Time: 1 Year

Measure: The risk of coagulopathy by measuring Prothrombin time & Partial Thromboplastin time

Time: 1 Year

Measure: The risk of coagulopathy by measuring D-Dimer

Time: 1 Year

Measure: The risk of coagulopathy by measuring Platelet Counts

Time: 1 Year

Other Outcomes

Measure: The percentage of patients with lung fibrosis or worsening of lung fibrosis from screening to Day 10 and Day 24 (as assessed by CT).

Time: 10 Days, 17 Days, & 24 Days

Measure: Maximal inspiratory pressure (MIP) at Day 10, Day 17 and Day 24.

Time: 10 Days, 17 Days, & 24 Days

Measure: Maximal expiratory pressure (MEP) at Day 10, Day 17, and Day 24.

Time: 10 Days, 17 Days, & 24 Days

Measure: Muscle strength assessment at Day 10, Day 17 and Day 24.

Time: 10 Days, 17 Days, & 24 Days

Description: Pharmacokinetics of Aralast NP levels will be drawn to determine if there is a correlation between that and the other endpoints listed above.

Measure: Correlation between plasma exposure of Aralast NP (Pharmacokinetics) and the other listed clinical endpoints at Days 1, 3, 5, 7, 9 and 17.

Time: 1 Day, 3 Days, 5 Days, 7 Days, 9 Days, & 17 Days

Measure: Correlation between plasma exposure of Aralast NP (Pharmacokinetics) and biomarker endpoints (Pharmacodynamics) at Days 1, 6, 10 and 17

Time: 1 Day, 6 Days, 10 Days, & 17 Days

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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