Clinical trials: ARDS, Human
COVID-19, ARDS
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients…
- Trial name
- EXIT-COVID19 (NCT04493242)
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Direct Biologics, LLC
Acute Respiratory Distress Syndrome
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress…
- Trial name
- NCT04502433
- Testing
- CUROSURF® (poractant alfa)
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Acute Respiratory Failure, Coma
EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients
The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.
- Conditions
- Acute Respiratory Failure, Coma, Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- NCT04400643
- Testing
- INTELLiVENT-ASV, Non-automated ventilation
- Where
- Portugal
- Volunteers
- 62 people
- Sponsor
- Hamilton Medical AG
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
COVID-19
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 To evaluate the clinical efficacy of…
- Trial name
- NCT04426695
- Testing
- REGN10933+REGN10987 combination therapy
- Where
- 123 sites in United States, Brazil and 4 more
- Volunteers
- 2,252 people
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Distress Syndrome, Adult
COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22.
- Trial name
- NCT04388826
- Testing
- Veru-111
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Veru Inc.
Sepsis, Acute Lung Injury
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS.
- Conditions
- Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome
- Trial name
- NCT01438853
- Testing
- TNX-832
- Where
- 7 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Altor BioScience
SARS-CoV-2 (COVID-19) Severe Pneumonia
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
- Trial name
- NCT04412668
- Testing
- Efzofitimod 1 mg/kg, Efzofitimod 3 mg/kg
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 36 people
- Sponsor
- aTyr Pharma, Inc.
Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
Efficacy and Safety of Itolizumab in COVID-19 Complications
Randomized, Parallel Group, Active Controlled Trial
- Conditions
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- Trial name
- NCT04475588
- Testing
- Itolizumab IV infusion, Best supportive care (BSC)
- Where
- 4 sites in India
- Volunteers
- 32 people
- Sponsor
- Biocon Limited
Acute Respiratory Distress Syndrome, SARS-CoV-2
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
- Trial name
- NCT04565249
- Testing
- PLN-74809
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Pliant Therapeutics, Inc.
Lung Injury, Acute
SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre study for subjects with trauma (physical injury) who are at risk for developing Acute Lung Injury (ALI) or Acute Respiratory Distress…
- Trial name
- NCT00996840
- Testing
- SB-681323 Intravenous 3mg, SB-681323 Intravenous 7.5 mg, SB-681323 Intravenous 7.5mg
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- GlaxoSmithKline
Coronavirus Disease 2019, Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
Study of Varespladib in Patients Hospitalized With Severe COVID-19
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients…
- Trial name
- STAIRS (NCT04969991)
- Testing
- Varespladib
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ophirex, Inc.
SARS-CoV Infection
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
- Trial name
- VERU-111 (NCT04842747)
- Testing
- VERU-111
- Where
- 58 sites in United States, Argentina and 4 more
- Volunteers
- 204 people
- Sponsor
- Veru Inc.
Acute Respiratory Distress Syndrome, Covid19
Study of Descartes-30 in Acute Respiratory Distress Syndrome
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
- Trial name
- NCT04524962
- Testing
- Descartes 30
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Cartesian Therapeutics
COVID-19, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
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.
- Trial name
- NCT04389671
- Testing
- Lucinactant
- Where
- 11 sites in United States, Argentina
- Volunteers
- 20 people
- Sponsor
- Windtree Therapeutics
COVID, Severe Acute Respiratory Syndrome
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy…
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury
- Trial name
- NCT04402957
- Testing
- LSALT peptide
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 61 people
- Sponsor
- Arch Biopartners Inc.
COVID-19
A 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)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Severe to Critical COVID 19 With Associated ARDS
A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
This is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS.
- Trial name
- NCT04750278
- Testing
- FP-025 100 mg, FP-025 300 mg
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Pneumonia, Viral
Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDS
The goal of this study is to evaluate the effects of Ibudilast (MN-166) versus placebo in hospitalized patients infected with COVID-19 at risk for developing acute respiratory distress syndrome (ARDS) receiving standard of care…
- Trial name
- NCT04429555
- Testing
- Ibudilast
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- MediciNova
Acute Respiratory Distress Syndrome, COVID-19
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
The purpose of this study was to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.
- Trial name
- NCT04537806
- Testing
- Brexanolone
- Where
- 9 sites in United States
- Volunteers
- 29 people
- Sponsor
- Sage Therapeutics