CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D055370: Lung Injury NIH

(Synonyms: Lung In, Lung Injury)

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


Correlated Drug Terms (55)


Name (Synonyms) Correlation
drug2422 TD-0903 Wiki 0.30
drug1948 Pulmonary and Motor Rehabilitation Wiki 0.21
drug425 CAStem Wiki 0.21
drug224 Assessment of Dietary Changes in Adults in the Quarantine Wiki 0.21
drug1394 Lung CT scan analysis in COVID-19 patients Wiki 0.21
drug254 Aviptadil by intravenous infusion + standard of care Wiki 0.21
drug2438 Tacrolimus Wiki 0.21
drug1841 Placebo for Hydroxychloroquine Wiki 0.21
drug2036 Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid Wiki 0.21
drug2079 Respiratory Exercise Training Wiki 0.21
drug783 Dociparastat sodium Wiki 0.21
drug1644 Normal Saline Infusion + standard of care Wiki 0.21
drug191 Antibody Test Wiki 0.21
drug1393 Lucinactant Wiki 0.21
drug2281 Sodium Nitrite Wiki 0.21
drug1839 Placebo capsules Wiki 0.21
drug161 Anakinra 100Mg/0.67Ml Inj Syringe Wiki 0.21
drug432 CERC-002 Wiki 0.21
drug1837 Placebo Tablet Wiki 0.21
drug1362 Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki 0.21
drug157 Ampion Wiki 0.21
drug1840 Placebo for Azithromycin Wiki 0.21
drug137 Airway pressure release ventilation Wiki 0.21
drug1301 Knowledge, Attitude, Practice, Awareness, Preference Wiki 0.21
drug2119 Ruxolitinib administration Wiki 0.21
drug1769 Patient Education Wiki 0.21
drug282 BCG Wiki 0.21
drug2022 Ramelteon 8mg Wiki 0.21
drug263 Azithromycin (Azithro) Wiki 0.21
drug1579 Nebulized administration of RLF-100 or Placebo Wiki 0.21
drug128 Aerobic Exercise Training Wiki 0.21
drug204 Apple Watch Series 5 Wiki 0.21
drug112 Access to training facility Wiki 0.21
drug998 Gimsilumab Wiki 0.21
drug8 0.9% Sodium-chloride Wiki 0.21
drug2807 eculizumab Wiki 0.21
drug262 Azithromycin Wiki 0.18
drug2031 Ravulizumab Wiki 0.15
drug1642 Normal Saline Wiki 0.15
drug335 Best Supportive Care Wiki 0.15
drug1047 Heparin Wiki 0.15
drug1303 L-ascorbic acid Wiki 0.15
drug2129 SARS-CoV-2 Wiki 0.15
drug2003 RLF-100 (aviptadil) Wiki 0.15
drug2256 Siltuximab Wiki 0.15
drug1163 Ibrutinib Wiki 0.15
drug1822 Placebo Wiki 0.11
drug1087 Hydroxychloroquine (HCQ) Wiki 0.11
drug2612 Usual Care Wiki 0.10
drug1086 Hydroxychloroquine Wiki 0.08
drug159 Anakinra Wiki 0.08
drug2527 Tocilizumab Wiki 0.08
drug1484 Methylprednisolone Wiki 0.06
drug1860 Placebos Wiki 0.05
drug2319 Standard of Care Wiki 0.04

Correlated MeSH Terms (15)


Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.34
D012128 Respiratory Distress Syndrome, Adult NIH 0.31
D063806 Myalgia NIH 0.21
D012127 Respiratory Distress Syndrome, Newborn NIH 0.21
D014947 Wounds and Injuries NIH 0.19
D004417 Dyspnea NIH 0.16
D011024 Pneumonia, Viral NIH 0.08
D013577 Syndrome NIH 0.07
D011014 Pneumonia NIH 0.06
D007249 Inflammation NIH 0.04
D018352 Coronavirus Infections NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D016638 Critical Illness NIH 0.03
D014777 Virus Diseases NIH 0.03
D007239 Infection NIH 0.01

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0003326 Myalgia HPO 0.21
HP:0002098 Respiratory distress HPO 0.16
HP:0002090 Pneumonia HPO 0.06

There are 22 clinical trials

Clinical Trials


1 Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.

NCT04311697 Critical COVID-19 With Respiratory Failure Acute Respiratory Distress Syndrome (ARDS) Corona Virus Infection Acute Lung Injury Drug: Aviptadil by intravenous infusion + standard of care Drug: Normal Saline Infusion + standard of care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Mortality

Measure: Mortality

Time: 5 Days with followup through 30 days

Description: Index of Respiratory Distress

Measure: PaO2:FiO2 ratio

Time: 5 Days with followup through the end of telemetry monitoring

Secondary Outcomes

Description: TNF alpha levels as measured in hospital laboratory

Measure: TNF alpha

Time: 5 Days

Description: Multi-system organ failure free days

Measure: Multi-system organ failure free days

Time: 5 days with followup through 30 days

2 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

3 Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19

The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.

NCT04341038 COVID-19 Lung Injury Drug: Tacrolimus Drug: Methylprednisolone
MeSH:Lung Injury Wounds and Injuries

Primary Outcomes

Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpm

Measure: Time to reach clinical stability

Time: 28 days

Secondary Outcomes

Description: days

Measure: Time to reach an afebrile state for 48 hours.

Time: 56 days

Description: days

Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300

Time: 56 days

Description: days

Measure: Time to reach FR ≤ 24 rpm for 48 hours

Time: 56 days

Description: days

Measure: Time to normalization of D-dimer (<250 ug / L)

Time: 56 days

Description: days

Measure: Time until PCR normalization (<5mg / L).

Time: 56 days

Description: days

Measure: Time until normalization of ferritin (<400ug / L)

Time: 56 days

Description: viral load

Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR

Time: 56 days

Description: days

Measure: Time until hospital discharge

Time: 56 days

Description: days

Measure: Need for ventilatory support devices

Time: 56 days

Description: days

Measure: Duration that it is necessary to maintain ventilatory support.

Time: 56 days

Description: days

Measure: COVID-19 mortality

Time: 56 days

Description: days

Measure: all-cause mortality

Time: 56 days

Description: cytokines quantification technique by Luminex

Measure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission

Time: 56 days

Description: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance

Measure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone.

Time: 56 days

4 Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (EVICT-CORONA-ALI)

This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.

NCT04344184 COVID-19 Lung Injury, Acute Drug: L-ascorbic acid Other: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Description: Documented days free off mechanical ventilation the first 28 days post enrollment

Measure: Number of ventilator-free days

Time: Up to 28 days

Secondary Outcomes

Description: Mortality at 28-days by all causes

Measure: All-cause-mortality

Time: Up to 28 days

Description: Number of days free of acute inflammation (defined as CRP >= 10 mg/L)

Measure: Acute-inflammation-free days

Time: Up to 28 days

Description: Number of days that the participant is free of organ failure in ALL of the following organ systems: Cardiovascular, Respiratory, Neurological, Liver, Bone marrow organ, Renal

Measure: Organ-failure-free days

Time: Up to 1 year

5 A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.

NCT04350736 Acute Lung Injury (ALI) Associated With COVID-19 Inflammatory Lung Conditions Associated With COVID-19 Drug: TD-0903 Drug: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Number and severity of treatment emergent adverse events

Measure: Safety and Tolerability of SAD of TD-0903: Adverse Events

Time: Day 1 to Day 8

Description: Number and severity of treatment emergent adverse events

Measure: Safety and Tolerability of MAD of TD-0903: Adverse Events

Time: Day 1 to Day 14

Secondary Outcomes

Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC

Time: Day 1 through Day 4

Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax

Time: Day 1 through Day 4

Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax

Time: Day 1 through Day 4

Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC

Time: Day 1 through Day 9

Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax

Time: Day 1 through Day 9

Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax

Time: Day 1 through Day 9

6 A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)

Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

NCT04351243 COVID-19 Drug: Gimsilumab Drug: Placebo
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury

Primary Outcomes

Measure: Incidence of mortality

Time: Day 43

Secondary Outcomes

Measure: Incidence of subjects who are alive and not on mechanical ventilation

Time: Day 29

Description: Subjects who die will be assigned "0" ventilator-free days

Measure: Number of ventilator-free days

Time: Baseline to Day 29

Measure: Time to hospital discharge

Time: Baseline to Day 43

7 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


8 Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS A Single-arm, Open-label, Proof of Concept Study

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.

NCT04359290 ARDS, Human COVID Drug: Ruxolitinib administration
MeSH:Lung Injury Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: To determine the efficacy of ruxolitinib measured by overall survival

Measure: Overall survival

Time: 28 days after registration into trial

Secondary Outcomes

Description: Assessment of the duration of ventilation support

Measure: Assessment of the duration of ventilation support

Time: registration until 90 days after registration into trial

Description: Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)

Measure: cytokine storm

Time: registration until 90 days after registration into trial

Description: To assess time on ICU

Measure: time on ICU

Time: registration until 90 days after registration into trial

Description: To assess toxicity and safety of ruxolitinib treatment

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time: registration until 90 days after registration into trial

Description: To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

Measure: time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

Time: registration until 90 days after registration into trial

Description: To assess pulmonary function (time point discharge from hospital) by CT scan

Measure: pulmonary function assessed by a CT scan

Time: registration until 90 days after registration into trial

Description: To determine the efficacy of ruxolitinib measured by overall survival

Measure: overall survival

Time: 90 days after registration into trial

9 Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19

Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.

NCT04360096 SARS-CoV 2 COVID ARDS ALI Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Dyspnea Drug: RLF-100 (aviptadil) Drug: Placebo Device: Nebulized administration of RLF-100 or Placebo
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Dyspnea Lung Injury
HPO:Dyspnea Respiratory distress

Primary Outcomes

Description: Progression to ARDS is defined as the need for mechanical ventilation

Measure: Progression to ARDS

Time: 28 days

Secondary Outcomes

Description: Blood PO2 as measured by pulse oximetry

Measure: Blood oxygenation

Time: 28 days

Description: 0 = no shortness of breath at all 0.5 = very, very slight shortness of breath = very mild shortness of breath = mild shortness of breath = moderate shortness of breath or breathing difficulty = somewhat severe shortness of breath = strong or hard breathing 7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity

Measure: RDP Dsypnea Scale

Time: 28 days

Description: Distance walked in six minutes

Measure: Distance walked in six minutes

Time: 28 days

10 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 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: Duration of intensive care unit stay at Day 29

Time: Baseline, Day 29

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

Time: Baseline, Day 29

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

Time: Baseline, Day 29

Measure: Duration of hospitalization at Day 29

Time: Baseline, Day 29

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

Time: Baseline, Day 60, Day 90

11 IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

NCT04375397 CoronaVirus Induced Disease-2019 (COVID-19) Drug: Ibrutinib Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Lung Injury

Primary Outcomes

Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

Measure: Percentage of Participants Alive and Without Respiratory Failure

Time: Day 28

Secondary Outcomes

Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).

Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline

Time: Day 14

Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.

Measure: Median Reduction in Days Spent on Supplemental Oxygen

Time: Up to Day 28

Description: Percentage of participants with mortality from any cause.

Measure: All-Cause Mortality

Time: Up to Day 28

Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

Measure: Percentage of Participants Experiencing Respiratory Failure or Death

Time: Up to Day 28

Description: Percentage of participants alive and not requiring mechanical ventilation.

Measure: Mechanical Ventilation-Free Survival

Time: Up to Day 56

Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.

Measure: Days on Mechanical Ventilation

Time: Up to Day 56

Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.

Measure: Duration of hospitalization

Time: Up to Day 56

Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.

Measure: Time to Discharge

Time: Up to Day 56

Description: PaO2:FiO2 ratio is an index of respiratory distress.

Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio

Time: Up to Day 56

Description: Oxygenation Index is a parameter of pulmonary function of participants.

Measure: Oxygenation Index

Time: Up to Day 56

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Measure: Number of Participants With Adverse Events

Time: Up to Day 56

Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Measure: Number of Participants With Abnormal Laboratory Findings

Time: Up to Day 56

12 Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital

COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.

NCT04381338 Corona Virus Disease 19 (COVID-19) COVID Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Critical Illness Other: Pulmonary and Motor Rehabilitation
MeSH:Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Critical Illness Virus Diseases

Primary Outcomes

Description: days of ICU stay

Measure: Length of ICU stay

Time: up to 60 days

Secondary Outcomes

Description: days of hospital stay

Measure: Length of hospital stay

Time: up to 90 days

13 Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2

Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ ________________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. A study demonstrated that the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure. pretreatment of B38-CAP markedly down regulated a massive increase of plasma Ang II levels at 5 min after Ang II injection In addition to the currently used drugs to inhibit Ang II generation or signaling, such as ACE inhibitors or Angiotensin receptor blockers, direct down-modulation of Ang II levels by rhACE2 protein is one of the promising candidates for new therapeutic strategy in cardiovascular disease and other Ang II-related diseases, e.g. ARDS. On the other hand, although mass production of rhACE2 as a protein drug costs due to requirement of mammalian cell expression systems, B38-CAP is easily prepared with E. coli expression system and is cost effective. Therapeutic efficacy and less toxicity in mouse heart failure models would warrant further investigation of B38-CAP or other microbial carboxypeptidases in disease models. Finally the principal investigator expects that treatment with ACE2-like enzyme of bacteria B38-CAP expected to work efficiently Like human ACE2 and it will save the lung cells from COVID - 19 inhibitory effect and down regulation of ACE2 because COVID-19 binds to human ACE2 and down regulates it and this receptors is very important for lung cells survival and function So ,the principal investigator also expects that B38-CAP ACE2 like enzyme may be not recognized by COVID -19 spike protein because evolutionary it is too far away from human ace2 and human ACE2 is a real receptor of COVID -19 not ACE2 like enzyme but in the same time it will make the same function of human ACE2 In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening . So, the principal investigator expects strong inhibition of COVID - 19 infection And rescuing the lung cells from its serious attack by treating with ACE2 like enzyme and Isotretinoin Keywords: COVID 2019 , Isotretinoin,B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.

NCT04382950 COVID Combination Product: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid
MeSH:Lung Injury

Primary Outcomes

Description: Compare the time course of body temperature (fever) between two groups over time.

Measure: Time course of body temperature (fever)

Time: at 14 days

Secondary Outcomes

Description: Compare viral load between two groups over time.

Measure: Viral load over time

Time: 14 days

Description: PaO2/FiO2 ratio

Measure: P/F ratio over time

Time: 14 days

Description: SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.

Measure: Sequential organ failure assessment score(SOFA score) over time

Time: 14 days

Measure: Pulmonary Severity Index (PSI)

Time: 14 days

Description: Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.

Measure: Image examination of chest over time

Time: 14 days

Measure: Proportion of subjects who progressed to critical illness or death

Time: at 14 days

Measure: Time from first dose to conversion to normal or mild pneumonia

Time: 14 days

Measure: T-lymphocyte counts over time

Time: 14 days

Measure: C-reactive protein levels over time

Time: 14 days

Measure: Angiotensin II (Ang II) changes over time

Time: 14 days

Measure: Angiotensin 1-7 (Ang 1-7) changes over time

Time: 14 days

Measure: Angiotensin 1-5 (Ang 1-5) changes over time

Time: 14 days

Measure: Renin changes over time

Time: 14 days

Measure: Aldosterone changes over time

Time: 14 days

Measure: Angiotensin-converting enzyme (ACE) changes over time

Time: 14 days

Measure: Interleukin 6 (IL-6) changes over time

Time: 14 days

Measure: Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time

Time: 14 days

Measure: Plasminogen activator inhibitor type-1 (PAI-1) changes over time

Time: 14 days

Measure: Von willebrand factor (vWF) changes over time

Time: 14 days

Measure: Tumor necrosis factor-α (TNF-α) changes over time

Time: 14 days

Measure: Soluble receptor for advanced glycation end products (sRAGE) changes over time

Time: 14 days

Measure: Surfactant protein-D (SP-D) changes over time

Time: 14 days

Measure: Frequency of adverse events and severe adverse events

Time: 14 days

14 A Multicenter, Single-Treatment Study to Assess the Safety and Preliminary Efficacy of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury

This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.

NCT04389671 COVID-19 Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Drug: Lucinactant
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury

Primary Outcomes

Description: The AUC for OI through 12 hours measured using the trapezoidal method, where OI is defined as mean airway pressure (Paw)×fraction of inspired oxygen (FiO2)×100/arterial pressure of oxygen (PaO2)

Measure: Oxygenation index (OI) area under the curve (AUC)0-12

Time: 12 hours post initiation of dosing

Secondary Outcomes

Description: FiO2 change from baseline

Measure: FiO2

Time: 24 hours post initiation of dosing

Description: PaO2 change from baseline

Measure: PaO2

Time: 24 hours post initiation of dosing

Description: SpO2 change from baseline

Measure: Oxygenation from pulse oximetry (SpO2)

Time: 24 hours post initiation of dosing

Description: Change from baseline in P/F ratio, defined as PaO2/FiO2

Measure: P/F ratio

Time: 24 hours post initiation of dosing

Description: Change from baseline in VI, defined as [respiration rate (RR)×(peak inspriatory pressure [PIP] − peak expiratory end pressure [PEEP])× arterial pressure of carbon dioxide (PaCO2)]/1000

Measure: Ventilation Index (VI)

Time: 24 hours post initiation of dosing

Description: Change from baseline in lung compliance, as measured by the ventilator

Measure: Lung compliance

Time: 24 hours post initiation of dosing

15 A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

NCT04389840 COVID-19 Acute Lung Injury SARS-CoV-2 Drug: Dociparastat sodium Drug: Placebo
MeSH:Respiratory Insufficiency Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Alive and free of invasive mechanical ventilation

Measure: Proportion of participants who are alive and free of invasive mechanical ventilation

Time: Through Day 28

Secondary Outcomes

Description: Time to all-cause mortality

Measure: All-cause mortality

Time: Through Day 28

16 Lung CT Scan Analysis of SARS-CoV2 Induced Lung Injury by Machine Learning: a Multicenter Retrospective Cohort Study.

This is a multicenter observational retrospective cohort study that aims to study the morphological characteristics of the lung parenchyma of SARS-CoV2 positive patients identifiable in patterns through artificial intelligence techniques and their impact on patient outcome.

NCT04395482 covid19 Other: Lung CT scan analysis in COVID-19 patients
MeSH:Lung Injury

Primary Outcomes

Description: Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT through artificial intelligence techniques.

Measure: A qualitative analysis of parenchymal lung damage induced by COVID-19

Time: Until patient discharge from the hospital (approximately 6 months)

Description: Describe the parenchymal lung damage induced by COVID-19 through a quantitative analysis with chest CT through artificial intelligence techniques.

Measure: A quantitative analysis of parenchymal lung damage induced by COVID-19

Time: Until patient discharge from the hospital (approximately 6 months)

Secondary Outcomes

Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as intensive care mortality.

Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure.

Time: Until patient discharge from the hospital (approximately 6 months)

Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as hospital mortality.

Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure.

Time: Until patient discharge from the hospital (approximately 6 months)

Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as days free from mechanical ventilation.

Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure.

Time: Until patient discharge from the hospital (approximately 6 months)

Description: The hypothesis is that the uso of deep neural network models for lung segmentation in Acute Respiratory Distress Syndrome (ARDS) in animal models and Chronic Obstructive Pulmonary Disease (COPD) in patients that could be applied to self-segment the lungs of COVID-19 patients through a learning transfer mechanism with artificial intelligence.

Measure: Automated segmentation of lung scans of patients with COVID-19 and ARDS.

Time: Until patient discharge from the hospital (approximately 6 months)

Description: Expand the knowledge of chest CT features in COVID-19 patients and their detail through the use of machine learning and other quantitative techniques comparing CT patterns of COVID-19 patients to those of patients with ARDS.

Measure: Knowledge of chest CT features in COVID-19 patients and their detail through the use of machine learning and other quantitative techniques.

Time: Until patient discharge from the hospital (approximately 6 months)

Description: Determine the capacity within which the artificial intelligence analysis that uses deep learning models can be used to predict clinical outcomes from the analysis of the characteristics of the chest CT obtained within 7 days of hospital admission; combining quantitative CT data with clinical data.

Measure: The ability within which the analysis of artificial intelligence that uses deep learning models can be used to predict clinical outcomes

Time: Until patient discharge from the hospital (approximately 6 months)

17 Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury

Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19

NCT04397510 Covid-19 ARDS, Human Acute Lung Injury Drug: Heparin Drug: 0.9% Sodium-chloride
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Measure: Mean daily PaO2 to FiO2 ratio

Time: 10 days

Secondary Outcomes

Measure: Duration of mechanical ventilation

Time: 30 days

Measure: ICU length of stay

Time: 30 days

Measure: Mortality Rate

Time: 30 days

Measure: Incidence of adverse drug events

Time: 10 days

18 Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

NCT04401527 COVID-19 Acute Respiratory Distress Syndrome Acute Respiratory Failure Drug: Sodium Nitrite Drug: Normal Saline
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Proportion of study subjects who are alive and free of respiratory failure at Day 28

Measure: Survival with Unassisted Breathing

Time: Day 28

Secondary Outcomes

Description: Number of days alive without mechanical ventilation from start of study through Day 28

Measure: Survival without Mechanical Ventilation

Time: Day 28

Description: Number of days alive and not in the intensive care unit from start of study through Day 28.

Measure: Survival without Intensive Care

Time: Day 28

Description: Number of days alive and not in hospital from start of study through Day 28.

Measure: Survival without Hospitalization

Time: Day 28

Description: Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.

Measure: Survival without ECMO

Time: Day 28

Description: Alive on Day 28

Measure: Survival

Time: Day 28

Other Outcomes

Description: Oxygenation index (PaO2/FIO2) at Day 14

Measure: Lung Status

Time: Day 14

Description: Blood urea nitrogen (BUN) at Day 14

Measure: Kidney Status (1)

Time: Day 14

Description: Creatinine at Day 14

Measure: Kidney Status (2)

Time: Day 14

Description: Liver function tests (ALT and AST) at Day 14

Measure: Liver Status

Time: Day 14

19 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19

This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

NCT04402866 Acute Lung Injury (ALI) Associated With COVID-19 Lung Inflammation Associated With COVID-19 Drug: TD-0903 Drug: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Change from baseline in SaO2/FiO2 ratio

Measure: Part 2: SaO2/FiO2 ratio

Time: Baseline, Day 7

Description: Number of days the subject was not using invasive mechanical ventilation or non-invasive positive pressure ventilation

Measure: Part 2: Ventilator-free Days (VFDs)

Time: Baseline through Day 28

Secondary Outcomes

Description: Number of days the subject was not in the ICU

Measure: Part 2: Intensive Care Unit Free Days (ICU-free)

Time: Baseline through Day 28

Description: Area under the plasma concentration-time curve (AUC) in SaO2/FiO2 ratio

Measure: Part 2: AUC in SaO2/FiO2 ratio

Time: Baseline through Day 7

Description: Change from baseline in SaO2/FiO2 ratio

Measure: Part 2: SaO2/FiO2 ratio

Time: Baseline, Day 5

Description: Proportion of subjects with a SaO2/FiO2 ratio > 315

Measure: Part 2: SaO2/FiO2 ratio > 315

Time: Day 5, Day 7

Description: Proportion of subjects discharged

Measure: Part 2: Subjects Discharged

Time: Day 7, 14, 21 and 28

Description: Time to hospital discharge

Measure: Part 2: Hospital Discharge

Time: Baseline through up to Day 28

Description: The subject mortality rate (all causes)

Measure: Part 2: Mortality Rate

Time: Day 28

Description: Change from baseline in the modified Borg Dyspnea Score. The modified Borg Dyspnea Score is based on a 10-point scale that measures shortness of breath. Scores range from 0 (nothing at all, no shortness of breath) to 10 (maximal shortness of breath).

Measure: Part 2: Modified Borg Dyspnea Score

Time: Baseline through Day 7

Description: Proportion of subjects in each category of the Clinical Status scale. The Clinical Status scale contains 6 different categories that are each assigned a numeric score. The values range from 1 (representing 'Not hospitalized'), 2 (hospitalized, not requiring supplemental oxygen), 3 (hospitalized, requiring low-flow oxygen supplementation), 4 (hospitalized, on non-invasive positive pressure ventilation or high-flow oxygen supplementation), 5 (hospitalized, on invasive mechanical ventilation, 6 (Death).

Measure: Part 2: Clinical Status Scale

Time: Day 7, 14, 21 and 28

Description: Proportion of subjects in each category of Vital Status, where the categories are defined as death, discharge, or hospitalized.

Measure: Part 2: Vital Status

Time: Day 7, 14, 21 and 28

20 A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID 19 Pneumonia and Acute Lung Injury

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT, for the treatment of patients with COVID-19 pneumonia who have mild to moderate ARDS. LIGHT is a cytokine in the TNF super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.

NCT04412057 COVID-19 Pneumonia Acute Lung Injury ARDS Drug: CERC-002 Drug: Placebo
MeSH:Pneumonia Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries
HPO:Pneumonia

Primary Outcomes

Description: Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation, Extracorporeal membrane oxygenation

Measure: Proportion of patient alive and free of respiratory failure

Time: Baseline to Day 28

Secondary Outcomes

Description: 1-month mortality

Measure: Proportion of subjects who are alive

Time: Baseline to Day 28

21 Knowledge, Attitude and Practice About COVID-19 and Awareness of Infection Control to Prevent COVID-19 Transmission in Clinics and Perception About Online Learning During Lock Down Period: A Cross-sectional Study

Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.

NCT04449081 Acute Respiratory Distress Syndrome Corona Virus Infection Acute Lung Injury Fever Myalgia Cough Dyspnea Septic Shock Bleeding Behavioral: Knowledge, Attitude, Practice, Awareness, Preference
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Myalgia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Dyspnea Lung Injury
HPO:Dyspnea Myalgia Respiratory distress

Primary Outcomes

Description: KAP towards COVID-19 was assessed using validated questionnnaire

Measure: Knowledge, Attitude, Practice of dental students towards COVID-19

Time: 4 months

Secondary Outcomes

Description: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire

Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics

Time: 4 months

Description: Preference towards online learning. was assessed using a standard questionnaire

Measure: Preference towards online learning.

Time: 4 months

22 Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19

COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. The investigators proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.

NCT04470297 Covid19 Lung Injury Drug: Ramelteon 8mg
MeSH:Lung Injury

Primary Outcomes

Description: Defined as a National Early Warning Score 2 (NEWS2) of 0 maintained for 24 hours [Time Frame: Assessed daily (enrollment is day 0)] The NEWS consists of a simple aggregate scoring system based on physiological measurements, regularly registered in inpatient settings, including six parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and temperature.

Measure: Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0]

Time: enrollment is day 0

Secondary Outcomes

Description: Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death

Measure: Clinical worsening to critical COVID-19 illness

Time: until Day 30

Description: Measured by duration of use of supplemental oxygen (if applicable)

Measure: Duration of supplemental oxygen therapy

Time: until day 14

Description: Measured by duration of use of mechanical ventilation

Measure: Duration of mechanical ventilation (if applicable)

Time: until day 30

Description: Measured by duration of hospitalization

Measure: Duration of hospitalisation

Time: until day 30

Description: Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions

Measure: Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR

Time: Day 14

Description: Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission

Measure: C-reactive protein (CRP) level's reduction

Time: Days 3, 5 and 8

Description: Incidence of new onset lymphopenia during hospitalization measured by blood draw

Measure: Incidence of New Onset Lymphopenia

Time: Through study completion, average of 15 days

Description: Reduction of mean direct bilirubin levels in comparison with levels at the admission

Measure: Direct bilirubin level's reduction

Time: Measured in study Days 3, 5, and 8

Description: Differences in number of patients in study arms who experienced side effects

Measure: Side Effects

Time: until day 14


HPO Nodes