Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

Phase 2

Withdrawn

• Conditions: Covid19
• Interventions: Biological: Placebo; Biological: COVI-MSC

• Registration Number: NCT04992247
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief Summary

This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

Detailed Description

This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-05
• Study Start: 2024-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-07
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
• Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
• Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
• Willing to follow contraception guidelines

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Exclusion Criteria

• Clinically improving pulmonary status over the month prior to screening
• Undergone a previous stem cell infusion unrelated to this trial
• Pregnant or breast feeding or planning for either during the study
• Suspected uncontrolled active bacterial, fungal, viral, or other infection
• Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
• History of a splenectomy, lung transplant or lung lobectomy
• Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Excipient
COVI-MSC	COVI-MSC	Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)

Primary Outcome Measures

Name	Time	Method
Change in 6-Minute Walk Distance (6MWD) at Day 60	Baseline to Day 60	Change in 6MWD at Day 60

Secondary Outcome Measures

Name	Time	Method
Change in 6MWD at Day 30	Baseline to Day 30	Change in 6MWD at Day 30
Change in Pulmonary Function	Baseline to Day 30 and Day 60	Change in pulmonary function at Days 30 and 60, as measured by the single-breath test
Change in biomarker levels	Baseline to Day 60	Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
Relief of symptoms on Day 30 and Day 60	Baseline to Day 30 and Day 60	Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit
Change in oxygenation	Baseline to Day 30 and Day 60	Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio