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

A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Biological: COVI-MSC; Biological: Placebo

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mike Royal, MD; Phone Number: 4146 (858)203-4100; Email: mroyal@sorrentotherapeutics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Excipient	Biological: Placebo; 6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
Experimental: COVI-MSC; Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)	Biological: COVI-MSC; 2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-Minute Walk Distance (6MWD) at Day 60	Change in 6MWD at Day 60	Baseline to Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6MWD at Day 30	Change in 6MWD at Day 30	Baseline to Day 30
Relief of symptoms on 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	Baseline to Day 30 and Day 60
Change in Pulmonary Function	Change in pulmonary function at Days 30 and 60, as measured by the single-breath test	Baseline to Day 30 and Day 60
Change in oxygenation	Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio	Baseline to Day 30 and Day 60
Change in biomarker levels	Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor	Baseline to Day 60

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.
• Investigators: Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: covid19; long haul; post-acute covid
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MSC-PLH-201BR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No