CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D011024: Pneumonia, Viral NIH

(Synonyms: Pneumonia, Viral)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (73)


Name (Synonyms) Correlation
drug552 Nitric Oxide Wiki 0.24
drug264 Discontinuation of ACEi/ARB Wiki 0.17
drug166 CYNK-001 Wiki 0.17
drug294 Examine the impact of COVID-19 during pregnancy Wiki 0.17
drug365 Hydroxychloroquine + azithromycin + / - tocilizumab Wiki 0.17
drug258 Dexamethasone Wiki 0.17
drug961 hydroxychloroquine + azithromycin Wiki 0.17
drug389 Hydroxychloroquine and Azithromycin Wiki 0.17
drug666 Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) Wiki 0.17
drug205 Clopidogrel Wiki 0.17
drug1030 standardized Lung Ultrasound (LUS) examination Wiki 0.17
drug792 Sterile Normal Saline for Intravenous Use Wiki 0.17
drug923 alveolar recruitment Wiki 0.17
drug367 Hydroxychloroquine + placebo Wiki 0.17
drug887 VC Wiki 0.17
drug183 Centricyte 1000 Wiki 0.17
drug119 Biological collection (patients co infected HIV Sras-CoV-2) Wiki 0.17
drug143 CAStem Wiki 0.17
drug607 Pembrolizumab (MK-3475) Wiki 0.17
drug299 Exposure (not intervention) - SARS-CoV-2 infection Wiki 0.17
drug81 Azinc Wiki 0.17
drug315 Fondaparinux Wiki 0.17
drug735 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.17
drug1038 turkish physicians Wiki 0.17
drug951 eculizumab Wiki 0.17
drug874 UNIKINON (Chloroquine phosphate) 200mg tablets Wiki 0.17
drug623 Placebo for Hydroxychloroquine Wiki 0.17
drug581 Oral placebo Wiki 0.17
drug682 Ravulizumab Wiki 0.17
drug622 Placebo for Azithromycin Wiki 0.17
drug121 Biological test Wiki 0.17
drug567 Normal saline Wiki 0.17
drug409 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.17
drug715 SARS-CoV-2 IgG Antibody Testing Kit Wiki 0.17
drug31 Acetylsalicylic acid Wiki 0.17
drug463 Liberase Enzyme (Roche) Wiki 0.17
drug500 Mefloquine + azithromycin + / - tocilizumab Wiki 0.17
drug377 Hydroxychloroquine Sulfate + Azithromycin Wiki 0.17
drug426 Injective placebo Wiki 0.17
drug588 Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki 0.17
drug798 Study Group Wiki 0.17
drug83 Azithromycin (Azithro) Wiki 0.17
drug74 Auto-questionnaires (patients co infected HIV Sras-CoV-2) Wiki 0.17
drug561 No special intervention Wiki 0.17
drug229 Convalescent anti-SARS-CoV-2 plasma Wiki 0.17
drug499 Mefloquine Wiki 0.17
drug967 iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki 0.17
drug114 Best Supportive Care Wiki 0.17
drug339 Halo Oral Spray Wiki 0.17
drug217 Continuation of ACEi/ARB Wiki 0.17
drug793 Sterile Water for Injection Wiki 0.17
drug851 Tirofiban Injection Wiki 0.17
drug509 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.17
drug340 Halo Placebo Wiki 0.17
drug107 Baricitinib Wiki 0.12
drug555 Nivolumab Wiki 0.12
drug752 SivoMixx (200 billion) Wiki 0.12
drug364 Hydroxychloroquine + azithromycin Wiki 0.12
drug648 Prednisone Wiki 0.12
drug313 Follow up Wiki 0.12
drug361 Hydroxychloroquine (HCQ) Wiki 0.10
drug960 hydroxychloroquine Wiki 0.10
drug484 Lung ultrasound Wiki 0.10
drug222 Control group Wiki 0.10
drug872 UC-MSCs Wiki 0.09
drug208 Colchicine Wiki 0.08
drug732 Sarilumab Wiki 0.07
drug46 Anakinra Wiki 0.06
drug360 Hydroxychloroquine Wiki 0.06
drug558 No intervention Wiki 0.06
drug375 Hydroxychloroquine Sulfate Wiki 0.05
drug854 Tocilizumab Wiki 0.04
drug82 Azithromycin Wiki 0.04

Correlated MeSH Terms (34)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.45
D008171 Lung Diseases, NIH 0.26
D053717 Pneumonia, Ventilator-Associated NIH 0.19
D017563 Lung Diseases, Interstitial NIH 0.17
D001261 Pulmonary Atelectasis NIH 0.17
D011251 Pregnancy Complications, Infectious NIH 0.17
D011248 Pregnancy Complications NIH 0.17
D054990 Idiopathic Pulmonary Fibrosis NIH 0.17
D007154 Immune System Diseases NIH 0.17
D011649 Pulmonary Alveolar Proteinosis NIH 0.17
D016769 Embolism and Thrombosis NIH 0.17
D004617 Embolism NIH 0.17
D045169 Severe Acute Respiratory Syndrome NIH 0.17
D055370 Lung Injury NIH 0.16
D055371 Acute Lung Injury NIH 0.14
D018352 Coronavirus Infections NIH 0.13
D012127 Respiratory Distress Syndrome, Newborn NIH 0.13
D030341 Nidovirales Infections NIH 0.12
D012327 RNA Virus Infections NIH 0.12
D012128 Respiratory Distress Syndrome, Adult NIH 0.11
D003333 Coronaviridae Infections NIH 0.10
D011658 Pulmonary Fibrosis NIH 0.10
D004417 Dyspnea NIH 0.10
D008173 Lung Diseases, Obstructive NIH 0.09
D003141 Communicable Diseases NIH 0.08
D013577 Syndrome NIH 0.08
D007239 Infection NIH 0.07
D013927 Thrombosis NIH 0.07
D012140 Respiratory Tract Diseases NIH 0.06
D007251 Influenza, Human NIH 0.06
D014777 Virus Diseases NIH 0.06
D002318 Cardiovascular Diseases NIH 0.05
D012141 Respiratory Tract Infections NIH 0.04
D016638 Critical Illness NIH 0.04

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0002098 Respiratory distress HPO 0.12
HP:0002090 Pneumonia HPO 0.11

There are 34 clinical trials

Clinical Trials


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

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

NCT04260308 Virus; Pneumonia
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

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

Time: 2 weeks

Secondary Outcomes

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

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

Time: 2 weeks

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

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

NCT04264533 Vitamin C Pneumonia, Viral Pneumonia, Ventilator-Associated Drug: VC Drug: Sterile Water for Injection
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Ventilation-free days

Time: on the day 28 after enrollment

Secondary Outcomes

Description: wether the patient survives

Measure: 28-days mortality

Time: on the day 28 after enrollment

Description: days of the patients staying in the ICU

Measure: ICU length of stay

Time: on the day 28 after enrollment

Description: the rate of CPR

Measure: Demand for first aid measuments

Time: on the day 28 after enrollment

Description: days of using vasopressors

Measure: Vasopressor days

Time: on the day 28 after enrollment

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

Measure: Respiratory indexes

Time: on the day 10 and 28 after enrollment

Description: Ecmo or ventilator

Measure: Ventilator parameters

Time: on the day 10 and 28 after enrollment

Description: Acute Physiology and Chronic Health Evaluation

Measure: APACHE II scores

Time: on the day 10 after enrollment

Description: Sepsis-related Organ Failure Assessment

Measure: SOFA scores

Time: on the day 10 after enrollment

3 Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

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

NCT04269525 Pneumonia, Viral Pneumonia, Ventilator-Associated Biological: UC-MSCs
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Oxygenation index

Time: on the day 14 after enrollment

Secondary Outcomes

Description: whether the patient survives

Measure: 28 day mortality

Time: on the day 28 after enrollment

Description: days of the patients in hospital

Measure: Hospital stay

Time: up to 6 months

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

Measure: 2019-nCoV nucleic acid test

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

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

Measure: Improvement of lung imaging examinations

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

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

Measure: White blood cell count

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

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

Measure: Lymphocyte count

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

Description: percentage of lymphocyte in white blood cell

Measure: Lymphocyte percentage

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

Description: procalcitonin in microgram(ug)/L

Measure: Procalcitonin

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

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

Measure: interleukin(IL)-2

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

Description: IL-4 in pg/mL

Measure: IL-4

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

Description: IL-6 in pg/mL

Measure: IL-6

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

Description: IL-8 in pg/mL

Measure: IL-8

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

Description: IL-10 in pg/mL

Measure: IL-10

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

Description: TNF-α in nanogram(ng)/L

Measure: tumor necrosis factor(TNF)-α

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

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

Measure: γ-interferon(IFN)

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

4 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

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

NCT04290858 Coronavirus Infections Pneumonia, Viral Dyspnea Drug: Nitric Oxide
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea
HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

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

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

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

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

Time: 7 days

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

Measure: Time to clinical recovery

Time: 28 days

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

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

NCT04305457 Coronavirus Infections Pneumonia, Viral Acute Respiratory Distress Syndrome Drug: Nitric Oxide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

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

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

Time: 28 days

Secondary Outcomes

Description: Proportion of deaths from all causes

Measure: Mortality

Time: 28 days

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

Measure: Time to clinical recovery

Time: 28 days

Other Outcomes

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

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

Time: 7 days

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

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

NCT04313946 COVID-19 Pneumonia, Viral Influenza With Pneumonia Flu Symptom Flu Like Illness Pneumonia, Interstitial Pneumonia, Ventilator-Associated Pneumonia Atypical Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, V Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

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

Measure: COVID-19 positive X-Rays

Time: 6 months

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

Measure: COVID-19 negative X-Rays

Time: 6 months

7 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - Severely-ill Patients

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

NCT04321278 Coronavirus Infections Pneumonia, Viral Drug: Hydroxychloroquine + azithromycin Drug: Hydroxychloroquine
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

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

Measure: All-cause mortality

Time: 29 days after randomization

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

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

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

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

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

Measure: Duration of mechanical ventilation

Time: 7, 15 and 29 days after randomization

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 7, 15 and 29 days after randomization

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 7, 15 and 29 days after randomization

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 7, 15 and 29 days after randomization

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 7, 15 and 29 days after randomization

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 7, 15 and 29 days after randomization

Description: Occurrence of laboratory albnormalities in red blood cell count, creatinine and bilirubin

Measure: Laboratory albnormalities

Time: 7, 15 and 29 days after randomization

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

Measure: Adverse events

Time: 7, 15 and 29 days after randomization

8 Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method

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

NCT04322487 Coronavirus Epidemic Disease Pneumonia, Viral Diagnostic Test: Lung ultrasound
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Lung ultrasound grading system for COVID-19 pneumonia

Time: At enrollment.

9 COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA

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

NCT04322565 Coronavirus Infections Pneumonia, Viral Drug: Colchicine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Clinical improvement

Time: Day 28

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

Measure: Hospital discharge

Time: Day 28

Secondary Outcomes

Description: Number of death patients

Measure: Death

Time: Day 28

Description: 7-category ordinal scale

Measure: Clinical status

Time: Day 7, Day 14

Description: Number of patients with mechanical ventilhation

Measure: Mechanical ventilhation

Time: Day 28

Description: Days of hospitalization

Measure: Hospitalization

Time: Day 28

Description: Days to death from treatment initiation

Measure: Time from treatment initiation to death

Time: Day 28

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

Measure: Time to Negativization COVID 19

Time: Day 21

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

Measure: Fever

Time: Day 1,4,7,14,21,28

10 Time of Recovery and Prognostic Factors of Covid19 Pneumonia

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

NCT04324684 Pneumonia, Viral Hypertension Diabetes Mellitus Obesity Cardiovascular Diseases Obstructive Lung Disease
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive Cardiovascular Diseases
HPO:Abnormal lung morphology Abnormality of the cardiovascular system Obstructive lung disease Pneumonia

Primary Outcomes

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

Measure: rate of recovery

Time: 3 weeks

Secondary Outcomes

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

Measure: time to improvement

Time: 3 weeks

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

Measure: efficacy of treatments

Time: 3 weeks

Description: liver, kidney or multiorgan failure, cardiac failure

Measure: organ failure

Time: 3 weeks

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

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

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

Primary Outcomes

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

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

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

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

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

Measure: Digital Oximetry

Time: 3 months, 6 months

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

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

NCT04327401 Coronavirus Infection Pneumonia, Viral Acute Respiratory Distress Syndrome Drug: Dexamethasone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

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

Measure: Ventilator-free days

Time: 28 days after randomization

Secondary Outcomes

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

Measure: Evaluation of the clinical status

Time: 15 days after randomization

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

Measure: All-cause mortality

Time: 28 days after randomization

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

Measure: Mechanical ventilation duration

Time: 28 days after randomization

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

Measure: Sequential Organ Failure Assessment (SOFA) Score

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

Other Outcomes

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

Measure: Intensive Care Unit free days

Time: 28 days after randomization

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

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

NCT04330261 COVID-19 SARS-CoV-2 Infection Pediatric ALL Pneumonia, Viral Pandemic Response Other: Exposure (not intervention) - SARS-CoV-2 infection
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

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

Time: 18 months

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

Measure: Factors associated with severe COVID-19 outcomes

Time: 18 months

Secondary Outcomes

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

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

Time: 18 months

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

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

Time: 18 months

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

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

NCT04331613 COVID-19 Acute Respiratory Distress Syndrome Virus; Pneumonia Acute Lung Injury Biological: CAStem
MeSH:Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Syndrome
HPO:Pneumonia

Primary Outcomes

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

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

Time: Within 28 days after treatment

Description: Evaluation by chest CT

Measure: Changes of lung imaging examinations

Time: Within 28 days after treatment

Secondary Outcomes

Description: Marker for SARS-CoV-2

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

Time: Within 28 days after treatment

Description: The duration of a fever above 37.3 degrees Celsius

Measure: Duration of fever (Celsius)

Time: Within 28 days after treatment

Description: Marker for efficacy

Measure: Changes of blood oxygen (%)

Time: Within 28 days after treatment

Description: Marker for efficacy

Measure: Rate of all-cause mortality within 28 days

Time: Within 28 days after treatment

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

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

Time: Within 28 days after treatment

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

Measure: Alanine aminotransferase (U/L)

Time: Within 28 days after treatment

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

Measure: Creatinine (umol/L)

Time: Within 28 days after treatment

Description: Creatine kinase in U/L

Measure: Creatine kinase (U/L)

Time: Within 28 days after treatment

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

Measure: C-reactive protein (mg/L)

Time: Within 28 days after treatment

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

Measure: Procalcitonin (ng/L)

Time: Within 28 days after treatment

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

Measure: Lactate (mmol/L)

Time: Within 28 days after treatment

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

Measure: IL-1beta (pg/mL)

Time: Within 28 days after treatment

Description: IL-2 in pg/mL

Measure: IL-2 (pg/mL)

Time: Within 28 days after treatment

Description: IL-6 in pg/mL

Measure: IL-6 (pg/mL)

Time: Within 28 days after treatment

Description: IL-8 in pg/mL

Measure: IL-8 (pg/mL)

Time: Within 28 days after treatment

15 A Multicenter, Randomized, Open-Label, Phase II Trial to Evaluate the Efficacy and Safety of Checkpoint Blockade in Patients With Coronavirus Disease 2019 (COVID-19)-Related Mild Acute Respiratory Syndrome Nonresponsive to Frontline Therapy

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

NCT04335305 COVID-19 Pneumonia, Viral Drug: Tocilizumab Biological: Pembrolizumab (MK-3475)
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Assessed by hospital records

Measure: Percentage of patients with normalization of oxygen saturation by pulse oximetry (SpO2) ≥96%

Time: through day 14 after study treatment initiation

Secondary Outcomes

Description: Assessed by hospital records

Measure: Proportion of patients with temperature < 37,5 °C armpit.

Time: through day 14 after study treatment initiation

Description: Assessed by hospital records

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

Time: In less than 28 days

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

Measure: Change from baseline in organ failure parameters

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

Description: Determined as percentage of dead patients

Measure: Proportion of mortality rate

Time: Day 28

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

Measure: Analysis of the remission of respiratory symptoms

Time: Up to 3 months after last dose of treatment

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

Measure: Evaluation of the radiological response

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

Description: determined using oropharyngeal or anal swabs

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

Time: within 28 days from study inclusion

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

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

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

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

Measure: Change from baseline of hemoglobin

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

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

Measure: Change from baseline of platelets

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

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

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

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

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

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

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

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

Measure: Change from baseline of creatinine

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

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

Measure: Change from baseline of glucose

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

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

Measure: Change from baseline of total bilirubin

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

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

Measure: Change from baseline of albumin

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

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

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

Time: Up to 28 days after last dose of treatment

16 Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

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

NCT04336345 Coronavirus Infections COVID-19 Viral Pneumonia Human Coronavirus
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Mortality 30 days following hospital admission

Measure: Hospital mortality

Time: 30 days

Secondary Outcomes

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

Measure: Length of stay in the intensive care unit

Time: Through study completion, an average of 30 days

17 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

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

NCT04340466 Pneumonia, Viral Critically Ill Corona Virus Infection Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness Virus Diseases
HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

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

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28

18 Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19

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

NCT04341766 Pneumonia, Viral COVID-19 Other: No special intervention
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day one

Secondary Outcomes

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day 3

Description: description of ultrasound abnormalities for Covid-19 patients

Measure: Characteristics of pulmonary ultrasound for Covid-19 patients

Time: Day 14

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

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

Time: Day 1

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

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

Time: Day 3

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

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

Time: Day 14

19 Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection

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

NCT04344288 Viral Pneumonia Human Coronavirus COVID-19 Drug: Prednisone Other: Control group
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

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

Time: 7 days

Secondary Outcomes

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

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

Time: 7 days

Measure: number of patients with a supplemental oxygen use

Time: 7 days

Description: Reduction of radiological signs on chest imaging

Measure: radiological signs on chest imaging

Time: 7 days

Measure: number of patients transferred to intensive care unit

Time: 21 days

Measure: number of patients requiring invasive ventilation

Time: 21 days

Description: duration on days

Measure: Duration of oxygen therapy

Time: 21 days

Measure: number of adverse events induced by corticosteroid treatment

Time: 21 days

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

Time: 21 days

Measure: number of deaths

Time: 21 days

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

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

NCT04344951 Pneumonia, Viral Covid-19 Drug: UNIKINON (Chloroquine phosphate) 200mg tablets
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

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

Time: Day 8 visit from study initiation

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

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

Time: Day 8 visit from study initiation

Secondary Outcomes

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

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

Time: Day 14 visit from study initiation

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

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

Time: Day 14 visit from study initiation

Description: Frequency of AEs and SAEs

Measure: Frequency of AEs and SAEs

Time: Day 14 visit from study initiation

21 Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multi-stage, 6-armed Placebo-controlled Trial in the Framework of an Adaptive Trial Platform

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT04345289 COVID Corona Virus Infection Viral Pneumonia Biological: Convalescent anti-SARS-CoV-2 plasma Drug: Sarilumab Drug: Baricitinib Drug: Hydroxychloroquine Other: Injective placebo Other: Oral placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Virus Diseases
HPO:Pneumonia

Primary Outcomes

Description: Composite outcome

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

Time: 28 days

Secondary Outcomes

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

Measure: Frequency of adverse events

Time: 90 days

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

Measure: Frequency of severe adverse events

Time: 90 days

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

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

Time: 90 days

Description: Number of days without mechanical ventilation

Measure: Ventilator-free days

Time: 28 days

Description: Number of days without organ-failure

Measure: Organ failure-free days

Time: 28 days

Description: Number of days in ICU

Measure: Duration of ICU stay

Time: 90 days

Description: Number of deaths by any cause

Measure: Mortality rate

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

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

Measure: Length of hospital stay

Time: 90 days

Description: Days requiring supplement oxygen

Measure: Duration of supplemental oxygen

Time: 90 days

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

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

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

Primary Outcomes

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

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

Time: up to Day 11

Secondary Outcomes

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

Measure: Clinical status assessed by ordinal scale

Time: up to Day 29

Description: Necessity for transfer to Intensive care unit

Measure: transfer to ICU

Time: up to Day 29

Description: days from admission to hospital discharge

Measure: Length of hospital day

Time: up to Day 29

Description: incidence of all-cause mortality

Measure: Hospital Mortality

Time: Day 29

Description: Need to mechanical ventilation

Measure: Need to Mechanical Ventilation

Time: up to Day 29

Description: adverse reactions

Measure: Occurence of grade 3-4 adverse event

Time: up to Day 29

Description: ECG

Measure: QTc Lengthening

Time: up to Day 11

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

Measure: Evolution of pulmonary CT scan images

Time: up to Day 11

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

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

NCT04347031 Pneumonia, Viral Respiratory Failure Drug: Mefloquine Drug: Hydroxychloroquine Combination Product: Mefloquine + azithromycin + / - tocilizumab Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

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

Measure: 1st primary endpoint for group 1

Time: up to 3 months

Description: The period of clinical recovery.

Measure: 2nd primary endpoint for group 1

Time: through study completion, an average of 3 months

Description: The period of clinical recovery.

Measure: 1st primary endpoint for group 2

Time: through study completion, an average of 3 months

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

Measure: 2nd primary endpoint for group 2

Time: through study completion, an average of 3 months

Secondary Outcomes

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

Measure: 1st secondary endpoint for group 1

Time: on days 5, 10 and 90

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

Measure: 2nd secondary endpoint for group 1

Time: on day 10

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

Measure: 3d secondary endpoint for group 1

Time: up to 3 months

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

Measure: 4th secondary endpoint for group 1

Time: up to 3 months

Description: Respiratory index.

Measure: 5th secondary endpoint for group 1

Time: up to 3 months

Description: Frequency of adverse events and serious adverse events

Measure: 6th secondary endpoint for group 1

Time: through study completion, an average of 3 months

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

Measure: 1st secondary endpoint for group 2

Time: on days 5, 10 and 90

Description: Respiratory index.

Measure: 2nd secondary endpoint for group 2

Time: up to 3 months

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

Measure: 3d secondary endpoint for group 2

Time: up to 3 months

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

Measure: 4th secondary endpoint for group 2

Time: up to 3 months

Description: Number of patients required transition to alternative therapy schedule

Measure: 5th secondary endpoint for group 2

Time: through study completion, an average of 3 months

Description: Frequency of adverse events and serious adverse events

Measure: 6th secondary endpoint for group 2

Time: through study completion, an average of 3 months

24 A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic

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

NCT04353141 COVID Pregnancy Complications, Infectious Pregnancy Related Pregnancy, High Risk Pregnancy Disease Pneumonia Pneumonia, Viral Diagnoses Disease Diagnostic Test: standardized Lung Ultrasound (LUS) examination
MeSH:Pregnancy Complications, Infectious Pneumonia, Viral Pneumonia Pregnancy Complications
HPO:Pneumonia

Primary Outcomes

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

Measure: Diagnostic performance of LUS to predict poor outcome

Time: outcome one week after enrollment into the study

25 SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

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

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


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

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

NCT04356508 COVID-19 SARS-CoV-2 2019-nCoV Pneumonia, Viral Drug: Nivolumab
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Measure: Viral clearance kinetics

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

Secondary Outcomes

Description: Incidence and severity of treatment-related adverse events

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

Time: Up to 1 year after nivolumab dosing

Description: Changes in lymphocyte counts

Measure: Lymphocyte kinetics

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

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

Measure: Cytokine kinetics

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

Measure: Length of inpatient stay due to COVID-19

Time: From hospital admission to discharge, assessed up to 6 months

27 Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

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

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


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

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

NCT04359706 Sars-CoV2
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: relative abundances and diversity indices

Measure: Composition of the fecal bacterial and fungal microbiota

Time: At 28 days

Secondary Outcomes

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

Measure: Analysis of the faecal microbiota from rectal swab

Time: at baseline and every 7 days during 28 days

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

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

Time: at baseline and every 7 days during 28 days

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

Measure: Serum inflammatory markers changes

Time: at 28 days,

Description: changes in Cytokine/ chemokine from baseline

Measure: Inflammatory markers changes

Time: at 28 days,

Description: death

Measure: Mortality

Time: at 28 days,

Description: Number of days alive without mechanical ventilation

Measure: mechanical ventilation free days

Time: at 28 days,

29 PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)

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

NCT04360837 COVID-19 Virus; Pneumonia Atelectasis Procedure: alveolar recruitment
MeSH:Pneumonia, Viral Pneumonia Pulmonary Atelectasis
HPO:Atelectasis Pneumonia

Primary Outcomes

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

Measure: Changes in lung compliance

Time: 20 minutes

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

Measure: Change in global impedance

Time: 20 minutes

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

Measure: Change in recruitability

Time: 7 days

Secondary Outcomes

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

Measure: Gas exchange

Time: 20 minutes and 7 days

Description: Change in plateau pressure (cmH2O) following recruitment

Measure: Plateau pressure

Time: 20 minutes and 7 days

Description: Change in end expiratory lung impedance (%)

Measure: End expiratory lung impedance (EELI)

Time: 20 minutes and 7 days

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

Measure: Antero-to-posterior ventilation ratio

Time: 20 minutes and 7 days

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

Measure: Center of ventilation

Time: 20 minutes and 7 days

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

Measure: Global inhomogeneity index

Time: 20 minutes and 7 days

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

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

NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovir Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

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

Time: Up to 12 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR

Measure: Time to Clearance of SARS-CoV-2

Time: Up to 12 months

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

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 12 months

Description: Time from the date of randomization to the first date of clinical improvement of cough.

Measure: Time to Clinical Improvement of cough

Time: Up to 28 days

Description: Time from the date of randomization to the first date of clinical improvement of fever

Measure: Time to Clinical Improvement of fever

Time: Up to 28 days

Description: Time from the date of randomization to the first date of clinical improvement of radiological evaluation of disease related chest x-ray

Measure: Time to Clinical Improvement in radiological evaluation of disease related chest x-ray

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of fever

Measure: Rate of Clinical Improvement of fever

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of cough

Measure: Rate of Clinical Improvement of cough

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of radiological evaluation of disease related chest x-ray

Measure: Rate of Clinical Improvement of radiological evaluation of disease related chest x-ray

Time: Up to 28 days

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

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

Description: Proportion of subjects who achieve pulmonary clearance

Measure: Rate of Pulmonary Clearance

Time: Up to 28 days

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

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

Time: Up to 28 days

Secondary Outcomes

Description: Number and severity of adverse events

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

Time: up to 12 months

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

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 12 months

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

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 12 months

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

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 12 months

31 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

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

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

Primary Outcomes

Description: Comparison between the two groups

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

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

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

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

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

Time: 21 days

Description: Comparison between the two groups

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

Time: 21 days

Description: Comparison between the two groups

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

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days

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

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

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

Primary Outcomes

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

Measure: P/F ratio

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

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

Measure: PaO2 difference

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

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

Measure: A-a O2 difference

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

Secondary Outcomes

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

Measure: CPAP duration

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

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

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

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

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

Measure: PaCO2 difference

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

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

Measure: HCO3- difference

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

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

Measure: Lactate difference

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

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

Measure: Hb difference

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

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

Measure: Plt difference

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

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

Measure: Adverse effects

Time: From the first day of study drugs administration until day 30 post study drugs administration

33 A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

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

NCT04369469 COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome Pneumonia, Viral Biological: Ravulizumab Other: Best Supportive Care
MeSH:Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Syndrome
HPO:Pneumonia

Primary Outcomes

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

Time: Baseline, Day 29

Secondary Outcomes

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

Time: Baseline, Day 29

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

Time: Baseline, Day 29

Measure: Duration of intensive care unit stay at Day 29

Time: Baseline, Day 29

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

Time: Baseline, Day 29

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

Time: Baseline, Day 60, Day 90

Measure: Duration of hospitalization

Time: Baseline, Day 29

34 Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia: a Multicenter Study in the Italian Outbreak

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

NCT04370275 COVID-19 Pneumonia, Viral
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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

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

Time: 30 days

Secondary Outcomes

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

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

Time: 30 days

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

Time: 30 days


HPO Nodes