CAP-1002 in Severe COVID-19 Disease

Summary

This expanded access protocol will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in critical condition as indicated by life support measurements. Eligible subjects will receive open-label intravenous administration of investigational product (CAP-1002) containing 150 million allogeneic Cardiosphere-Derived Cells (CDCs). CAP-1002 administration will be conducted at the investigative site on Day 1 and weekly up to a maximum of 4 doses, based on clinical course. Subjects will complete protocol assessments at Screening; Day 1; Weeks 1-3; and Follow-up by phone 30 and 90 days after the last infusion. Baseline assessments will be conducted prior to first infusion on Day 1. The patient will be observed during the lengths of hospitalization and monitored for outcome and safety. Safety and outcome data will be collected and reported at the conclusion of treatment and follow-up.

Timeline

Start

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Primary completion

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Completion

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Outcome

Met primary endpoint

release “its Phase 2, INSPIRE study evaluating a single-dose intravenous infusion of CAP-1002 as a potential treatment option for hospitalized patients with advanced symptoms of COVID-19 met its primary objective of safety” capricor.com ↗

Drugs

Indications