Name (Synonyms) | Correlation | |
---|---|---|
drug1386 | Low molecular weight heparin Wiki | 0.18 |
drug2257 | Silymarin Wiki | 0.13 |
drug456 | COVID-19 Convalscent Plasma Wiki | 0.13 |
drug425 | CAStem Wiki | 0.13 |
drug1971 | Quantitative IgG Test Wiki | 0.13 |
drug2619 | VC Wiki | 0.13 |
drug967 | Fourth Trimester Mobile Tool Wiki | 0.13 |
drug1002 | Glycine Wiki | 0.13 |
drug820 | Echo-Doppler Wiki | 0.13 |
drug3015 | standardized Lung Ultrasound (LUS) examination Wiki | 0.13 |
drug1340 | Liberase Enzyme (Roche) Wiki | 0.13 |
drug2205 | Scanning Chest X-rays and performing AI algorithms on images Wiki | 0.13 |
drug1093 | Hydroxychloroquine + placebo Wiki | 0.13 |
drug581 | Clinical assessment Wiki | 0.13 |
drug963 | Fondaparinux Wiki | 0.13 |
drug1621 | No special intervention Wiki | 0.13 |
drug671 | Corticosteroid injection Wiki | 0.13 |
drug2696 | Withings ScanWatch Wiki | 0.13 |
drug2934 | online survey Wiki | 0.13 |
drug3043 | ventilatory support with oxygen therapy Wiki | 0.13 |
drug1391 | Low-dose radiotherapy Wiki | 0.13 |
drug2079 | Respiratory Exercise Training Wiki | 0.13 |
drug146 | Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Wiki | 0.13 |
drug325 | Bedside lung ultrasound Wiki | 0.13 |
drug1460 | Mefloquine Wiki | 0.13 |
drug572 | Ciclesonide Inhalation Aerosol Wiki | 0.13 |
drug1461 | Mefloquine + azithromycin + / - tocilizumab Wiki | 0.13 |
drug2237 | Serological testing Wiki | 0.13 |
drug1719 | Oxygen supply Wiki | 0.13 |
drug2832 | high flow nasal cannula device Wiki | 0.13 |
drug1397 | Lung Ultrasound Wiki | 0.13 |
drug1904 | Prevalence of COVID-19 Wiki | 0.13 |
drug2535 | Tocilizumab Injection [Actemra] Wiki | 0.13 |
drug2737 | alveolar recruitment Wiki | 0.13 |
drug1160 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.13 |
drug161 | Anakinra 100Mg/0.67Ml Inj Syringe Wiki | 0.13 |
drug678 | Covid-19 Rapid Test Kit (RAPG-COV-019) Wiki | 0.13 |
drug1487 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.13 |
drug2586 | Ultra-Low-dose radiotherapy Wiki | 0.13 |
drug2103 | Ritonavir/lopinavir Wiki | 0.13 |
drug1720 | Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki | 0.13 |
drug1821 | Piperacillin/tazobactam Wiki | 0.13 |
drug2277 | Snorkel-based improvised personal protective equipment Wiki | 0.13 |
drug1464 | Melphalan Wiki | 0.13 |
drug567 | Chloroquine or hydroxychloroquine Wiki | 0.13 |
drug2362 | Sterile Water for Injection Wiki | 0.13 |
drug1396 | Lung Low Dose Radiation Wiki | 0.13 |
drug2462 | Telephone survey Wiki | 0.13 |
drug1573 | Nasopharyngeal (NP) swab Wiki | 0.13 |
drug2944 | patients receiving nasal high flow Wiki | 0.13 |
drug2841 | hydroxychloroquine + azithromycin Wiki | 0.13 |
drug2962 | predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? Wiki | 0.13 |
drug2349 | Standard treatment according to the Clinical protocols Wiki | 0.13 |
drug1164 | Ibudilast Wiki | 0.13 |
drug1722 | Ozanimod Wiki | 0.13 |
drug2475 | Test: Favipiravir 200 mg (LOQULAR) Wiki | 0.13 |
drug2887 | meplazumab for injection Wiki | 0.13 |
drug2821 | favorable outcome Wiki | 0.13 |
drug1043 | Helmet Continuous Positive Airway Pressure (CPAP) Wiki | 0.13 |
drug1769 | Patient Education Wiki | 0.13 |
drug2361 | Sterile Normal Saline for Intravenous Use Wiki | 0.13 |
drug505 | CYNK-001 Wiki | 0.13 |
drug2051 | Reference: Favipiravir 200 mg (Avigan) Wiki | 0.13 |
drug1091 | Hydroxychloroquine + azithromycin + / - tocilizumab Wiki | 0.13 |
drug1607 | Nitric Oxide delivered via LungFit™ system Wiki | 0.13 |
drug537 | Centricyte 1000 Wiki | 0.13 |
drug48 | 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.13 |
drug1203 | Infusion placebo Wiki | 0.13 |
drug188 | Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients Wiki | 0.13 |
drug657 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.13 |
drug124 | Additional biological samples Wiki | 0.13 |
drug128 | Aerobic Exercise Training Wiki | 0.13 |
drug2971 | pulmonary anomalies 4 months after documented COVID-19 pneumonia Wiki | 0.13 |
drug204 | Apple Watch Series 5 Wiki | 0.13 |
drug893 | Exposure (not intervention) - SARS-CoV-2 infection Wiki | 0.13 |
drug2582 | UNIKINON (Chloroquine phosphate) 200mg tablets Wiki | 0.13 |
drug899 | Extra blood sample Wiki | 0.13 |
drug1054 | High Flow Nasal Oxygen (HFNO) Wiki | 0.13 |
drug2850 | iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki | 0.13 |
drug1787 | Pembrolizumab (MK-3475) Wiki | 0.13 |
drug2847 | hyperimmune plasma Wiki | 0.13 |
drug15 | 150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.13 |
drug115 | Acetylsalicylic acid Wiki | 0.13 |
drug2241 | Serology for Covid-19 Wiki | 0.13 |
drug2522 | Tirofiban Injection Wiki | 0.13 |
drug2807 | eculizumab Wiki | 0.13 |
drug1604 | Nitric Oxide Wiki | 0.13 |
drug1399 | Lung ultrasound Wiki | 0.11 |
drug1090 | Hydroxychloroquine + azithromycin Wiki | 0.09 |
drug2191 | Sample collection Wiki | 0.09 |
drug107 | Acalabrutinib Wiki | 0.09 |
drug2031 | Ravulizumab Wiki | 0.09 |
drug1022 | HB-adMSCs Wiki | 0.09 |
drug2665 | Vitamin Super B-Complex Wiki | 0.09 |
drug335 | Best Supportive Care Wiki | 0.09 |
drug2271 | SivoMixx (200 billion) Wiki | 0.09 |
drug588 | Clopidogrel Wiki | 0.09 |
drug670 | Corticosteroid Wiki | 0.09 |
drug1610 | Nivolumab Wiki | 0.07 |
drug748 | Dexamethasone Wiki | 0.07 |
drug1444 | Mavrilimumab Wiki | 0.07 |
drug641 | Control group Wiki | 0.07 |
drug262 | Azithromycin Wiki | 0.06 |
drug2840 | hydroxychloroquine Wiki | 0.06 |
drug2326 | Standard of care Wiki | 0.06 |
drug1822 | Placebo Wiki | 0.06 |
drug2187 | Saliva collection Wiki | 0.06 |
drug2580 | UC-MSCs Wiki | 0.06 |
drug1898 | Prednisone Wiki | 0.06 |
drug2765 | blood sample Wiki | 0.05 |
drug1086 | Hydroxychloroquine Wiki | 0.05 |
drug2527 | Tocilizumab Wiki | 0.05 |
drug1598 | Nitazoxanide Wiki | 0.04 |
drug601 | Colchicine Wiki | 0.04 |
drug852 | Enoxaparin Wiki | 0.04 |
drug2116 | Ruxolitinib Wiki | 0.04 |
drug1372 | Lopinavir/ritonavir Wiki | 0.04 |
drug1484 | Methylprednisolone Wiki | 0.04 |
drug1103 | Hydroxychloroquine Sulfate Wiki | 0.03 |
drug1613 | No intervention Wiki | 0.03 |
drug923 | Favipiravir Wiki | 0.03 |
drug1978 | Questionnaire Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D011014 | Pneumonia NIH | 0.45 |
D008171 | Lung Diseases, NIH | 0.16 |
D017563 | Lung Diseases, Interstitial NIH | 0.16 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.15 |
D016769 | Embolism and Thrombosis NIH | 0.15 |
D030341 | Nidovirales Infections NIH | 0.13 |
D011251 | Pregnancy Complications, Infectious NIH | 0.13 |
D001261 | Pulmonary Atelectasis NIH | 0.13 |
D001469 | Barotrauma NIH | 0.13 |
D011649 | Pulmonary Alveolar Proteinosis NIH | 0.13 |
D018410 | Pneumonia, Bacterial NIH | 0.13 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.13 |
D053717 | Pneumonia, Ventilator-Associated NIH | 0.13 |
D018352 | Coronavirus Infections NIH | 0.12 |
D053120 | Respiratory Aspiration NIH | 0.10 |
D001987 | Bronchiectasis NIH | 0.09 |
D012140 | Respiratory Tract Diseases NIH | 0.09 |
D004646 | Emphysema NIH | 0.09 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.09 |
D008173 | Lung Diseases, Obstructive NIH | 0.08 |
D055370 | Lung Injury NIH | 0.08 |
D004617 | Embolism NIH | 0.08 |
D012120 | Respiration Disorders NIH | 0.07 |
D003333 | Coronaviridae Infections NIH | 0.06 |
D012327 | RNA Virus Infections NIH | 0.06 |
D055371 | Acute Lung Injury NIH | 0.06 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
D013927 | Thrombosis NIH | 0.06 |
D011658 | Pulmonary Fibrosis NIH | 0.06 |
D003141 | Communicable Diseases NIH | 0.05 |
D011248 | Pregnancy Complications NIH | 0.05 |
D007154 | Immune System Diseases NIH | 0.05 |
D007239 | Infection NIH | 0.05 |
D004417 | Dyspnea NIH | 0.05 |
D013577 | Syndrome NIH | 0.04 |
D020141 | Hemostatic Disorders NIH | 0.04 |
D007251 | Influenza, Human NIH | 0.04 |
D001778 | Blood Coagulation Disorders NIH | 0.04 |
D002318 | Cardiovascular Diseases NIH | 0.03 |
D012141 | Respiratory Tract Infections NIH | 0.03 |
D007249 | Inflammation NIH | 0.03 |
D016638 | Critical Illness NIH | 0.02 |
D014777 | Virus Diseases NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002090 | Pneumonia HPO | 0.45 |
HP:0002088 | Abnormal lung morphology HPO | 0.16 |
HP:0006515 | Interstitial pneumonitis HPO | 0.16 |
HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.13 |
HP:0100750 | Atelectasis HPO | 0.13 |
HP:0002110 | Bronchiectasis HPO | 0.09 |
HP:0006536 | Pulmonary obstruction HPO | 0.08 |
HP:0001907 | Thromboembolism HPO | 0.06 |
HP:0002206 | Pulmonary fibrosis HPO | 0.06 |
HP:0002098 | Respiratory distress HPO | 0.05 |
HP:0001928 | Abnormality of coagulation HPO | 0.04 |
HP:0011947 | Respiratory tract infection HPO | 0.03 |
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.03 |
There are 63 clinical trials
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.
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 weeksDescription: 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 weeks2019 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.
Description: days without ventilation support during 28 days after patients' enrollment
Measure: Ventilation-free days Time: on the day 28 after enrollmentDescription: wether the patient survives
Measure: 28-days mortality Time: on the day 28 after enrollmentDescription: days of the patients staying in the ICU
Measure: ICU length of stay Time: on the day 28 after enrollmentDescription: the rate of CPR
Measure: Demand for first aid measuments Time: on the day 28 after enrollmentDescription: days of using vasopressors
Measure: Vasopressor days Time: on the day 28 after enrollmentDescription: P O2/Fi O2 which reflects patients' respiratory function
Measure: Respiratory indexes Time: on the day 10 and 28 after enrollmentDescription: Ecmo or ventilator
Measure: Ventilator parameters Time: on the day 10 and 28 after enrollmentDescription: Acute Physiology and Chronic Health Evaluation
Measure: APACHE II scores Time: on the day 10 after enrollmentDescription: Sepsis-related Organ Failure Assessment
Measure: SOFA scores Time: on the day 10 after enrollmentSerious 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.
Description: partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
Measure: Oxygenation index Time: on the day 14 after enrollmentDescription: whether the patient survives
Measure: 28 day mortality Time: on the day 28 after enrollmentDescription: days of the patients in hospital
Measure: Hospital stay Time: up to 6 monthsDescription: whether or not the 2019-nCoV antibody is positive
Measure: 2019-nCoV antibody test Time: on the day 7,14,28 after enrollmentDescription: 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 enrollmentDescription: whether lung imaging examinations show the improvement of the pneumonia
Measure: Improvement of lung imaging examinations Time: on the day 7,14,28 after enrollmentDescription: counts of white blood cell in a litre of blood
Measure: White blood cell count Time: on the day 7,14,28 after enrollmentDescription: counts of lymphocyte in a litre (L) of blood
Measure: Lymphocyte count Time: on the day 7,14,28 after enrollmentDescription: procalcitonin in microgram(ug)/L
Measure: Procalcitonin Time: on the day 7,14,28 after enrollmentDescription: IL-2 in picogram(pg)/millilitre(mL)
Measure: interleukin(IL)-2 Time: on the day 7,14,28 after enrollmentDescription: IL-4 in pg/mL
Measure: IL-4 Time: on the day 7,14,28 after enrollmentDescription: IL-6 in pg/mL
Measure: IL-6 Time: on the day 7,14,28 after enrollmentDescription: IL-10 in pg/mL
Measure: IL-10 Time: on the day 7,14,28 after enrollmentDescription: TNF-α in nanogram(ng)/L
Measure: tumor necrosis factor(TNF)-α Time: on the day 7,14,28 after enrollmentDescription: γ-IFN in a thousand unit (KU)/L
Measure: γ-interferon(IFN) Time: on the day 7,14,28 after enrollmentDescription: CRP in microgram(μg)/L
Measure: C-reactive protein(CRP) Time: on the day 7,14,28 after enrollmentDescription: counts of CD4+ T-Lymphocytopenia in litre
Measure: CD4+ T-Lymphocytopenia Time: on the day 7,14,28 after enrollmentDescription: counts of CD8+ T-Lymphocytopenia in a litre
Measure: CD8+ T-Lymphocytopenia Time: on the day 7,14,28 after enrollmentDescription: counts of NK in a litre
Measure: natural killer cell(NK) Time: on the day 7,14,28 after enrollmentThe 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.
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 daysDescription: Mortality from all causes
Measure: Mortality Time: 28 daysDescription: 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 daysDescription: 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 daysThe 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.
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 daysDescription: Proportion of deaths from all causes
Measure: Mortality Time: 28 daysDescription: 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 daysDescription: 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 daysThis 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
Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive
Measure: COVID-19 positive X-Rays Time: 6 monthsDescription: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative
Measure: COVID-19 negative X-Rays Time: 6 monthsThe 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.
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 randomizationDescription: All-cause mortality rates at 29 days after randomization
Measure: All-cause mortality Time: 29 days after randomizationDescription: 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 randomizationDescription: Number of days free from mechanical ventilation at 29 days after randomization
Measure: Number of days free from mechanical ventilation Time: 29 days after randomizationDescription: Number of days that the patient was on mechanical ventilation after randomization
Measure: Duration of mechanical ventilation Time: 29 days after randomizationDescription: Length of hospital stay on survivors
Measure: Duration of hospitalization Time: 29 days after randomizationDescription: Presence of other secondary infections
Measure: Other secondary infections Time: 29 days after randomizationDescription: Time from treatment start to death
Measure: Time from treatment start to death Time: 29 days after randomizationDescription: 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 monthsDescription: Leucocyte transcriptome
Measure: Assess whether the tested therapies may be affected by leucocyte phenotype Time: BaselineDescription: Occurrence of QT interval prolongation
Measure: QT interval prolongation Time: 29 days after randomizationDescription: Occurrence of gastrointestinal intolerance
Measure: Gastrointestinal intolerance Time: 29 days after randomizationDescription: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin
Measure: Laboratory abnormalities Time: 29 days after randomizationDescription: Occurrence of adverse events related to the use of the investigational products
Measure: Adverse events Time: 29 days after randomizationGrowing 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.
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.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].
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 28Description: Live discharge from the hospital (whatever comes first)
Measure: Hospital discharge Time: Day 28Description: Number of death patients
Measure: Death Time: Day 28Description: 7-category ordinal scale
Measure: Clinical status Time: Day 7, Day 14Description: Number of patients with mechanical ventilhation
Measure: Mechanical ventilhation Time: Day 28Description: Days of hospitalization
Measure: Hospitalization Time: Day 28Description: Days to death from treatment initiation
Measure: Time from treatment initiation to death Time: Day 28Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Time to Negativization COVID 19 Time: Day 21Description: Time to remission of fever in patients with T>37.5°C at enrollment
Measure: Fever Time: Day 1,4,7,14,21,28It 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.
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 weeksDescription: 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 weeksDescription: the efficacy of different pharmaceutical treatment against Covid-19
Measure: efficacy of treatments Time: 3 weeksDescription: liver, kidney or multiorgan failure, cardiac failure
Measure: organ failure Time: 3 weeksCOVID-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.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: 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 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsThe 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.
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 randomizationDescription: 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 randomizationDescription: All-cause mortality rates at 28 days after randomization.
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days of mechanical ventilation from randomization to day 28.
Measure: Mechanical ventilation duration Time: 28 days after randomizationDescription: 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 randomizationDescription: 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 randomizationRationale: 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsA 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.
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 treatmentDescription: Evaluation by chest CT
Measure: Changes of lung imaging examinations Time: Within 28 days after treatmentDescription: Marker for SARS-CoV-2
Measure: Time to SARS-CoV-2 RT-PCR negative Time: Within 28 days after treatmentDescription: The duration of a fever above 37.3 degrees Celsius
Measure: Duration of fever (Celsius) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Changes of blood oxygen (%) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Rate of all-cause mortality within 28 days Time: Within 28 days after treatmentDescription: Counts of lymphocyte in a litre (L) of blood
Measure: Lymphocyte count (*10^9/L) Time: Within 28 days after treatmentDescription: Alanine aminotransferase in unit (U)/litre(L)
Measure: Alanine aminotransferase (U/L) Time: Within 28 days after treatmentDescription: Creatinine in micromole (umol)/litre(L)
Measure: Creatinine (umol/L) Time: Within 28 days after treatmentDescription: Creatine kinase in U/L
Measure: Creatine kinase (U/L) Time: Within 28 days after treatmentDescription: C-reactive in microgram (mg)/litre(L)
Measure: C-reactive protein (mg/L) Time: Within 28 days after treatmentDescription: Procalcitonin in nanogram (ng)/litre(L)
Measure: Procalcitonin (ng/L) Time: Within 28 days after treatmentDescription: Lactate in millimole(mmol)/litre(L)
Measure: Lactate (mmol/L) Time: Within 28 days after treatmentDescription: IL-1beta in picogram(pg)/millilitre(mL)
Measure: IL-1beta (pg/mL) Time: Within 28 days after treatmentDescription: IL-2 in pg/mL
Measure: IL-2 (pg/mL) Time: Within 28 days after treatmentDescription: IL-6 in pg/mL
Measure: IL-6 (pg/mL) Time: Within 28 days after treatmentDescription: IL-8 in pg/mL
Measure: IL-8 (pg/mL) Time: Within 28 days after treatmentThis is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial
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 initiationDescription: 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 entryDescription: Assessed by hospital records
Measure: Number of days of patient hospitalization Time: through End of Study, defined as 90 ± 14 days after study entryDescription: 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 entryDescription: 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 entryDescription: 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 inclusionDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 drugDescription: 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 entryThe 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.
Description: Mortality 30 days following hospital admission
Measure: Hospital mortality Time: 30 daysDescription: 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 daysSince 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.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28Clinical 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.
Description: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day oneDescription: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day 3Description: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day 14Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 1Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 3Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 14Infection 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.
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 daysDescription: level1: not hospitalized no limited activities, level 7: death
Measure: disease severity assessed on a 7-level ordinal scale Time: 7 daysDescription: Reduction of radiological signs on chest imaging
Measure: radiological signs on chest imaging Time: 7 daysDescription: duration on days
Measure: Duration of oxygen therapy Time: 21 daysThis 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.
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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: Frequency of AEs and SAEs
Measure: Frequency of AEs and SAEs Time: Day 14 visit from study initiationCCAP 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.
Description: Composite outcome
Measure: All-cause mortality or need of invasive mechanical ventilation Time: 28 daysDescription: Number of participants with adverse events with possible relation to study drug
Measure: Frequency of adverse events Time: 90 daysDescription: 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 daysDescription: 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 daysDescription: Number of days without mechanical ventilation
Measure: Ventilator-free days Time: 28 daysDescription: Number of days without organ-failure
Measure: Organ failure-free days Time: 28 daysDescription: Number of days in ICU
Measure: Duration of ICU stay Time: 90 daysDescription: Number of deaths by any cause
Measure: Mortality rate Time: 7, 14, 21, 28 and 90 daysDescription: Days from the date of hospital admission for COVID-19 to the date of discharge
Measure: Length of hospital stay Time: 90 daysDescription: Days requiring supplement oxygen
Measure: Duration of supplemental oxygen Time: 90 daysDouble 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.
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 11Description: 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 29Description: Necessity for transfer to Intensive care unit
Measure: transfer to ICU Time: up to Day 29Description: days from admission to hospital discharge
Measure: Length of hospital day Time: up to Day 29Description: incidence of all-cause mortality
Measure: Hospital Mortality Time: Day 29Description: Need to mechanical ventilation
Measure: Need to Mechanical Ventilation Time: up to Day 29Description: adverse reactions
Measure: Occurence of grade 3-4 adverse event Time: up to Day 29Description: ECG
Measure: QTc Lengthening Time: up to Day 11Description: 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 11Study 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.
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 daysDescription: The period of clinical recovery.
Measure: 2nd primary endpoint for group 1 Time: up to 10 daysDescription: The period of clinical recovery.
Measure: 1st primary endpoint for group 2 Time: up to 10 daysDescription: 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 monthsDescription: A change in viral load by conducting PCR assay through different timeframes
Measure: 1st secondary endpoint for group 1 Time: on days 5 and 10Description: Frequency of clinical cure on day 10 from the start of therapy
Measure: 2nd secondary endpoint for group 1 Time: on day 10Description: The retention time of the reaction temperature from the start of the treatment.
Measure: 3d secondary endpoint for group 1 Time: up to 10 daysDescription: Concentration of C-reactive protein in blood plasma.
Measure: 4th secondary endpoint for group 1 Time: up to 10 daysDescription: Respiratory index.
Measure: 5th secondary endpoint for group 1 Time: up to 10 daysDescription: Frequency appearance unwanted phenomena and serious unwanted phenomena
Measure: 6th secondary endpoint for group 1 Time: up to 10 daysDescription: A change in viral load by conducting PCR assay through different timeframes
Measure: 1st secondary endpoint for group 2 Time: on days 5 and 10Description: Respiratory index.
Measure: 2nd secondary endpoint for group 2 Time: up to 10 daysDescription: The retention time of the reaction temperature from the start of treatment.
Measure: 3d secondary endpoint for group 2 Time: up to 10 daysDescription: Concentration of C-reactive protein in blood plasma.
Measure: 4th secondary endpoint for group 2 Time: up to 10 daysDescription: Number of patients required transition to alternative therapy schedule
Measure: 5th secondary endpoint for group 2 Time: up to 10 daysDescription: Frequency of adverse events and serious adverse events
Measure: 6th secondary endpoint for group 2 Time: up to 10 daysCurrently 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.
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 studyThis protocol provides access to eculizumab treatment for participants with severe COVID-19.
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.
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 monthsDescription: 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 dosingDescription: Changes in lymphocyte counts
Measure: Lymphocyte kinetics Time: On days 1, 4, 6, 8, 10 and 28 from study enrollmentDescription: 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 enrollmentThe 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.
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.
Description: relative abundances and diversity indices
Measure: Composition of the fecal bacterial and fungal microbiota Time: At 28 daysDescription: 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 daysDescription: 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 daysDescription: 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,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.
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 minutesDescription: 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 minutesDescription: Estimation of change in global impedance (%) on a daily manner.
Measure: Change in recruitability Time: 7 daysDescription: Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
Measure: Gas exchange Time: 20 minutes and 7 daysDescription: Change in plateau pressure (cmH2O) following recruitment
Measure: Plateau pressure Time: 20 minutes and 7 daysDescription: Change in end expiratory lung impedance (%)
Measure: End expiratory lung impedance (EELI) Time: 20 minutes and 7 daysDescription: Change in antero-to-posterior ventilation ratio (%) following intervention
Measure: Antero-to-posterior ventilation ratio Time: 20 minutes and 7 daysDescription: Change in center of ventilation (%) following intervention
Measure: Center of ventilation Time: 20 minutes and 7 daysDescription: Change in global inhomogeneity index (%) following intervention
Measure: Global inhomogeneity index Time: 20 minutes and 7 daysThis 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 hospitalized patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: 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 12 monthsDescription: 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 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. 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 daysDescription: 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 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsDescription: 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 daysDescription: 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 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysItaly 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.
Description: Comparison between the two groups
Measure: Delta in the number of patients requiring orotracheal intubation despite treatment Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of crude mortality Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of length of stay for patients in hospital Time: 90 daysDescription: Comparison between the two groups
Measure: delta in the value of interleukin (IL)-1 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-6 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-10 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha Time: 21 daysDescription: 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 daysDescription: Comparison between the two groups
Measure: delta in the value of CD8+ CD38/ HLA-DR Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of fecal calprotectin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of lipopolysaccharide (LPS) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of zonulin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of alpha1-antitrypsin Time: 21 daysThis 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).
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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 administrationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 administrationThis 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.
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.
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 daysDescription: 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 daysThe investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.
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 groupDescription: 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 groupDescription: Number of patients who died in each of the groups
Measure: Mortality Time: 14 days followup for every patient in each groupDescription: 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 groupDescription: LOS in each of the groups
Measure: Length of hospital stay (LOS). Time: 14 days followup for every patient in each groupThis 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.
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 28Description: 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 28Description: 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 28Description: 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 28Description: 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 28Description: 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 28Description: 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 28Description: 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 28Low 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.
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 radiotherapyDescription: 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 radiotherapyDescription: Chest CT
Measure: Change of the radiological image Time: Days 7 and day 30 after interventional radiotherapyDescription: Death of any cause
Measure: Overall mortality Time: Day 15 and Day 30 after interventional radiotherapyDescription: 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 radiotherapyDescription: TGF-β (ng/ml)
Measure: Measure of trasforming growth factor (TGF-b) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: TNF-α (pg/ml)
Measure: Measure of tumor necrosis factor alpha (TNF-a) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: Overexpression of L-, E-, and P-selectin
Measure: Determining overexpression of pro-inflammatory selectin Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: Overexpression of ICAM-1, VCAM
Measure: Determining cell adhesion molecules (CAMs) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: 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 radiotherapyRandomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital Huddinge, 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 time (in days) of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
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 inclusionDescription: Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
Measure: Invasive mechanical ventilation or all-cause death Time: 30 days after study inclusionDescription: Rate of and time to (in days) death of any cause
Measure: All cause death Time: 30 days after study inclusionDescription: Rate of and time to (in days) received invasive mechanical ventilation
Measure: Invasive mechanical ventilation Time: 30 days after study inclusionDescription: Maximum received oxygen therapy during hospitalization in liters per minute
Measure: Maximum oxygen therapy Time: 30 days after study inclusionDescription: Time (in days) from study inclusion to discharge from hospital.
Measure: Duration of hospitalization Time: 30 days after study inclusionDescription: Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Measure: Remaining dyspnea symptoms Time: 3 and 6 months after inclusion. (Only for patients hospitalized at S:t Goran's Hospital)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.
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 daysDescription: Days spent in the ICU and hospital after time of enrollment
Measure: ICU and Hospital Length of Stay Time: 28 daysDescription: Incidence and time to intubation in days after the time of enrollment
Measure: Intubation Time: 28 daysDescription: Incidence of RRT after the time of enrollment
Measure: Renal Replacement Therapy (RRT) Time: 28 daysDescription: Death from any cause during after the time of enrollment
Measure: Mortality Time: 28 days, 90 daysTreatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Description: Number of patients cured, assessed by PCR in addition to chest CT scan
Measure: Number of cured patients Time: 3 weeksDescription: MSC infusion related adverse events assessed by blood count, liver and function tests
Measure: Number of patients with treatment-related adverse events Time: 3 weeksThis 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.
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 evaluationDescription: Duration of Hospitalization (days)
Measure: Length of Stay Time: 28 days from initial evaluationDescription: Descriptive analysis of ultrasound findings in Covid-19
Measure: Characterization of Ultrasound Findings Time: 28 days from initial evaluationNasal 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsMolecular 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.
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 weeksDescription: 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 weeksDescription: the efficacy of different pharmaceutical treatments against Covid-19
Measure: Efficacy of different pharmaceutical treatments Time: 3 weeksCoronavirus 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.
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 daysThe 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.
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 monthsDescription: 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 monthsDescription: Correlate imaging findings to OS
Measure: Ability of imaging to predict disease progression Time: Through study completion, an average of 5 monthsDescription: Correlate imaging findings over time
Measure: Ability of imaging to predict disease evolution Time: Through study completion, an average of 5 monthsDescription: Correlate imaging findings to age and sex
Measure: Imaging findings and demographic data Time: Through study completion, an average of 5 monthsDescription: Correlate imaging findings to laboratory values
Measure: Imaging findings and laboratory exams Time: Through study completion, an average of 5 monthsThe 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.
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 RTDescription: 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 RTDescription: Pa02 / Fi02 > 300 mmHg
Measure: Blood Gas Analysis at Day 2 Time: At 2 days after RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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 deathDescription: COVID-19 negativization test
Measure: COVID-19 status Time: At 7 days after RTDescription: 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 RTDescription: 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 RTA 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
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 daysDescription: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14
Measure: Clinical outcome Time: 7-14 daysDescription: 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 daysDescription: Total days of hospitalization
Measure: Hospitalization Time: Randomization till hospital discharge or death whichever came first, assessed up to 28 daysDescription: number of days patient remained with positive RT-PCR SARS-CoV-2 swab
Measure: Virologic Response Time: Randomization till discharge, up to 28 daysDescription: Any adverse events whether related to medication or not
Measure: Adverse events Time: Randomization till hospital discharge, up to 28 daysThis 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.
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 treatmentDescription: 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 28Description: 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 interventionDescription: 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 28Description: 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 interventionDescription: COVID-19-related death
Measure: Reduction in case fatality Time: Within day 28 of interventionDescription: 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 interventionDescription: 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 firstDescription: Median changes of NEWS2 score from baseline
Measure: Median changes in the National Early Warning Score 2 (NEWS2) Time: At day 7, 14, and 28Description: 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 firstDescription: 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 firstDescription: 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 84Description: 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 interventionDescription: Median changes in serum IL-6
Measure: Changes in serum IL-6 (exploratory biomarker) Time: By day 84Description: Median changes in serum IL-1 receptor antagonist
Measure: Changes in serum IL-1RA (exploratory biomarker) Time: By day 84Description: Median changes in serum TNF-alpha
Measure: Changes in serum TNF-alpha (exploratory biomarker) Time: By day 84Description: Median variations in haemoglobin and leucocyte counts
Measure: Changes in CBC + differential (exploratory biomarker) Time: By day 84Description: Median titres od anti-SARS-CoV2 antibodies
Measure: Level of anti-SARS-CoV2 antibodies (exploratory biomarker) Time: By day 84Description: Proportion of patients with a positive swab for SARS-CoV2 by PCR
Measure: Virus eradication (exploratory biomarker) Time: By day 84Description: Proportion of patients who developed anti-drug antibodies
Measure: Anti-drug antibodies (exploratory biomarker) Time: By day 84The 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.
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysDescription: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 DaysDescription: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 DaysDescription: Time to intubation
Measure: Time to intubation Time: 14 daysDescription: 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 daysDescription: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 daysDescription: Change in viral load
Measure: Change in viral load Time: 30 daysDescription: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 daysDescription: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 daysNovel 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 .
Description: Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19
Measure: Presence of viral pneumonia caused by COVID 19 Time: 3 monthsTo 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 .
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
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 daysDescription: 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 daysDescription: 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 daysThe 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
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 hoursDescription: radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
Measure: Torax X-ray Time: 48 hoursDescription: number of days of hospital stay.
Measure: Hospitalization Time: 2 monthsDescription: Number of days free of assisted mechanical respiration.
Measure: days free of assisted mechanical respiration Time: 3 monthDescription: number of deaths
Measure: Mortality Time: 3 monthsThe 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.
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.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.
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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthIn 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.
Description: 30-day mortality
Measure: Mortality Time: up to 30 daysDescription: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
Measure: Level-of-care Time: up to 7 daysDescription: in days
Measure: In-hospital length of stay Time: Up to 30 daysDescription: in hours
Measure: Emergency department length of stay Time: Within 24 hoursDescription: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.
Measure: Clinical correlation Time: Within 3 dayscoronavirus 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.
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 daysDescription: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg
Measure: blood gases Time: at the admission time and 24th hourThe 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.
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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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, 14Description: 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 daysDescription: 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 daysDescription: 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, 28Description: Proportion of subjects receiving mechanical ventilation or intubation.
Measure: Incidence of mechanical ventilation or intubation Time: Days 7, 14Description: Proportion of subjects requiring submission to the intensive care unit
Measure: Intensive care unit admission Time: 7 daysDescription: Blood sample collection to determine plasma concentrations of ibudilast.
Measure: Plasma concentrations of Ibudilast Time: 7 daysDescription: Number of deaths from any cause
Measure: All cause mortality Time: Days 7, 14, 28Pneumonia 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.
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 dischargeDescription: 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 dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV,%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeThis 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.
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.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.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.
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 admissionDescription: Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome
Measure: Risk factors 1 Time: Assessed at day 1Description: Studying if comorbidities were associated with an unfavorable outcome
Measure: Risk factors 2 Time: Assessed at day 1Description: 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 monthsThe 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.
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 daysDescription: 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 daysDescription: 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 treatmentDue 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.
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