COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04623671

Oren Friedman, MD

Tracey S Early, tracey.early@cshs.org (PI email not reported)

2020-11-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: male or female subjects at least 18 years of age at time of consent. diagnosis of sars-cov-2 infection confirmed by real-time reverse transcription polymerase chain reaction (rt-pcr) assay. compromised respiratory status as defined by arterial oxygen saturation < 92% (oxygen saturation measured by pulse oximetry) or cardiomyopathy due to covid-19 (defined as a new drop in ejection fraction to ≤ 50% during covid-19 with no evidence of obstructive coronary artery disease based on medical records review). elevation of at least 1 inflammatory marker (il-1, il-6, il-10, tnf-α, ferritin, crp) defined as ≥ 2x upper limit of laboratory normal reference value. written informed consent provided by subject or legal representative.

currently receiving extracorporeal membrane oxygenation (ecmo) or high frequency oscillatory ventilation (hfov). patients who have been intubated. patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia. patients with untreated human immunodeficiency virus (hiv) infection. creatinine clearance less than 30 ml/minute. liver function tests > 5x normal. current or history (within the previous 5 years) of systemic autoimmune or connective tissue disease. known allergy or hypersensitivity to any of the ip constituents such as dimethyl sulfoxide (dmso) or bovine proteins. treatment with a cell therapy product within 12 months prior to randomization. participation in an ongoing protocol studying an experimental drug or device. pregnant or breastfeeding female subjects, and sexually active female subjects of childbearing potential not willing to use contraceptive methods.

2

Capricor Inc.

18

100

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

63

Safety of CAP-1002: Incidence of All-Cause Mortality

None

Phase 2

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