A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)
Stopped: strategic reprioritization
Israel12 participantsStarted 2021-09-01
Plain-language summary
This is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of intravenous (IV) Allocetra-OTS 10x10\^9 cells vs placebo (1:1) in adult hospitalized patients with severe or critical Coronavirus Disease 2019 (COVID-19) with associated acute respiratory distress syndrome (ARDS). Patients will be followed for efficacy and safety for 6 months. The trial will include periodic and ad-hoc DSMB review during the study period.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Male and female \>18 and \<85 years of age.
✓. Laboratory confirmation of SARS-CoV-2 infection by RT-PCR from any diagnostic sampling source.
✓. Patient hospitalized due to COVID-19 within 7 days prior to enrollment, meeting the criteria for severe or critical COVID-19 as follows:
✓. Severe COVID-19 - defined as shortness of breath at rest, or respiratory distress, or RR ≥30 per minute, or SpO2≤93% on room air at sea level.
✓. Critical COVID-19 - defined as respiratory failure, requiring at least one of the following: oxygen delivered by high-flow nasal cannula or noninvasive positive pressure ventilation.
✓. Patient with mild to moderate ARDS:
✓. 100\< PaO2/FiO2 ≤300; based on the Berlin Definition of ARDS
✓. 148\< SpO2/FiO2 ≤315; based on the Kigali modification for ARDS
✕. Patient with weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
✕. Patient with stage 4 or 5 chronic kidney disease or estimated glomerular filtration rate \<30 mL/min.
✕. Patient with an active malignant tumor (diagnosed or on active treatment for the past 6 months).
✕. Patient who is participating in other concurrent interventional clinical trials or has been treated with any experimental agents within 30 days prior to enrollment.
✕. Patient who based on their medical history and receipt of therapies that would suggest infection, has suspected serious, active bacterial (including a suspected clinical diagnosis of current active tuberculosis \[TB\] or, if known, latent TB treated for less than 4 weeks with appropriate anti-TB therapy per institutional guidelines), fungal, or viral (including, but not limited to, active HBV, HCV, or HIV/AIDS) infection.
✕. Patient with known immunocompromised state or immunosuppressive medications taken for indications other than SARS-CoV-2 as follows: