Clinical trials: Severe ARDS
Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS)
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis…
- Conditions
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis, Lymphopenia
- Trial name
- NCT07492875
- Testing
- Nogapendekin alfa inbakicept (NAI), agenT-797
- Sponsor
- ImmunityBio, Inc.
Respiratory Infection, Pneumonia
Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired…
- Conditions
- Respiratory Infection, Pneumonia, Community-acquired Pneumonia, Acute Respiratory Distress Syndrome
- Trial name
- TRICOVID (NCT05531149)
- Testing
- Trimodulin
- Where
- 64 sites in Argentina, Austria and 12 more
- Volunteers
- 107 people
- Sponsor
- Biotest
ARDS (Moderate or Severe), AHRF
STimulation to Activate RespIration
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute…
- Conditions
- ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients
- Trial name
- STARI (NCT06832306)
- Testing
- Phrenic Nerve Stimulation
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Lungpacer Medical Inc.
COVID-19
Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
Study of ANA001 in Moderate and Severe COVID-19 Patients
- Trial name
- NCT04603924
- Testing
- Niclosamide
- Where
- 8 sites in United States
- Volunteers
- 49 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
COVID-19, Acute Respiratory Distress Syndrome (ARDS)
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID)…
- Trial name
- RESCUE (NCT04511650)
- Testing
- Razuprotafib Subcutaneous Solution
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- EyePoint Pharmaceuticals, Inc.
Covid19
COVID-19 Soliris Expanded Access Protocol
This protocol provides participants with COVID-19 access to Soliris.
- Trial name
- NCT04802083
- Testing
- Eculizumab
- Sponsor
- Alexion Pharmaceuticals, Inc.
Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).
- Trial name
- NCT04366830
- Testing
- Remestemcel-L
- Where
- United States
- Sponsor
- Mesoblast International Sàrl
COVID-19, ARDS
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of…
- Conditions
- COVID-19, ARDS, Acute Respiratory Distress Syndrome
- Trial name
- NCT04452097
- Testing
- Human umbilical cord mesenchymal stem cells + best supportive care
- Sponsor
- Baylx Inc.
Covid19, Corona Virus Infection
Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS
ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC)…
- Conditions
- Covid19, Corona Virus Infection, SARS-CoV Infection, ARDS
- Trial name
- ULSC (NCT04494386)
- Testing
- Umbilical Cord Lining Stem Cells (ULSC)
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Restem, LLC.
Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum
Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)
This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired…
- Conditions
- Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis, Lymphopenia / Immunoparalysis in Critically Ill Adults
- Trial name
- NCT07492888
- Testing
- Nogapendekin Alfa-Inbakicept (NAI), Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
- Sponsor
- ImmunityBio, Inc.
Covid19 Pneumonia
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
- Trial name
- NCT04569227
- Testing
- EC-18
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Enzychem Lifesciences Corporation
Acute Respiratory Distress Syndrome
A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study.
- Trial name
- TRISTARDS (NCT04640194)
- Testing
- Standard of care, Alteplase low dose, Alteplase high dose
- Where
- 37 sites in Austria, Belgium and 11 more
- Volunteers
- 104 people
- Sponsor
- Boehringer Ingelheim
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.
Covid19, Corona Virus Infection
Expanded Access to Zofin for Patients With COVID-19
This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider…
- Conditions
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), Acute Respiratory Distress Syndrome
- Trial name
- NCT04657406
- Testing
- Zofin
- Sponsor
- ZEO ScientifiX, Inc.
COVID, Covid-19
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen…
- Conditions
- COVID, Covid-19, Coronavirus, Coronavirus Infection
- Trial name
- NCT04402060
- Testing
- APL-9, Vehicle Control
- Where
- 24 sites in United States, Brazil
- Volunteers
- 72 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Acute Respiratory Distress Syndrome, ARDS
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with…
- Trial name
- NCT05354141
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 32 sites in United States
- Volunteers
- 970 people
- Sponsor
- Direct Biologics, LLC
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.
Acute Respiratory Distress Syndrome
Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works.
- Trial name
- NCT04609943
- Testing
- BAY1211163
- Where
- 4 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Bayer
Severe COVID-19 Disease
RAPA-501-Allo Therapy of COVID-19-ARDS
The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects.
- Trial name
- NCT04482699
- Testing
- RAPA-501-Allo off-the-shelf Therapy of COVID-19
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Rapa Therapeutics LLC
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.