CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
CAP-1002 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04623671
NCT04623671Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)

Capricor Inc.·interventional·Posted Nov 10, 2020·Updated Feb 20, 2025

In Brief

A Phase 2 clinical trial evaluating CAP-1002 and Placebo for Covid19. Completed, enrolled 55 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 10, 2020
Enrollment StartNov 15, 2020
Primary CompletionFeb 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.6 years ago

Interventions

CAP-1002biological

Peripheral infusion of 150 million cardiosphere-derived cells (CDCs)

Placebobiological

Matching placebo solution