Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) — RECOVER  

Covid19 Clinical Trial

Official title: A Phase 1 Double-blinded, Randomized, Placebo-controlled Study for COVID-19 and Influenza Virus-Elicited Acute Respiratory Distress Syndrome (ARDS) Using Lomecel-B

Status Active, not recruiting

Clinical Trial Summary

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.

Clinical Trial Description

Double-blinded, randomized, placebo-controlled study with 2 cohorts.

Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 2: 10 subjects treated with up to 3 doses of Placebo.

Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 4: 10 subjects treated with up to 3 doses of Placebo.

Each subject will be intravenously infused with 100 million Lomecel-B (formerly LMSCs) or placebo on Day 0. If no treatment-related AEs are seen after the infusion, a second infusion will be given on Day 3. If no treatment-related AEs are seen after the second infusion, a third infusion will be given Day 6.

Follow-up visits will be conducted: daily until hospital discharge; at Week 4 after treatment (with LMSCs or placebo) for patients already discharged; and at Month 6 after treatment (with LMSCs or placebo). ;

Related Conditions & MeSH terms

• ARDS, Human
• COVID-19
• Covid19
• Respiratory Distress Syndrome

• NCT number: NCT04629105
• Study type: Interventional
• Source: Longeveron Inc.
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 24, 2020
• Completion date: July 2025