Phase 2 Completed N=55 Randomized Double-blind Treatment

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

Covid19

Source: ClinicalTrials.gov NCT04623671 ↗

Enrolled (actual)

Serious AEs

29.1%

Results posted

Feb 2025

Primary outcomePrimary: Safety of CAP-1002: Incidence of All-Cause Mortality — 5; 6 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of CAP-1002: Incidence of All-Cause Mortality	5; 6	—

Eligibility Criteria

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 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.

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Data sourced from ClinicalTrials.gov (NCT04623671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.