There is one clinical trial.

Clinical Trials

1 A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19

This randomized, double-blind, placebo-controlled trial will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing. Eligible subjects will be randomized to either CAP-1002 or placebo in a 1:1 ratio. Intravenous administration of CAP-1002 or placebo will occur at the clinical site on Day 1 and Day 7 (± 1 day) for a maximum of 2 doses, based on clinical course. Subjects will complete Screening, a Treatment Phase and a Follow-up Phase. The Treatment Phase is variable based on each subject's clinical status while the subject remains in the hospital and will contain either one or two treatment periods. Baseline safety and efficacy assessments will be conducted prior to the first infusion. Follow-up will be conducted on Day 15 and Day 30 from the first infusion in Treatment Period 1. Subjects will be observed during the index hospitalization and monitored for outcome and safety. Transthoracic echocardiograms will be performed when indicated by clinical or laboratory evidence of cardiac involvement during the index hospitalization. Use of any concomitant medications to treat COVID-19 will be documented. Stopping rules on the subject-level and study-level have been defined to ensure subjects are not exposed to significant risk. Oversight of the trial will be provided by independent Clinical Event Committee (CEC), Data Safety Monitoring Board (DSMB), and Medical Monitor.

NCT04338347 COVID-19 Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells

No related HPO nodes (Using clinical trials)