Intravenous Infusion of CAP-1002 in Patients With COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

This is a randomized, double-blind, placebo-controlled, Pilot, Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures.

Key facts

Study ID

NCT04623671

Run by

Capricor Inc.

People needed

55

Starts

2020-11-15

Expected to finish

2022-02-04

Last updated by the study team

2025-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• Henry Ford Health System — Detroit, Michigan, United States
• PharmaTex Research, LLC — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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