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

NCT04992247 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MSC-PLH-201BR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

covid19; long haul; post-acute covid

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Distance (6MWD) at Day 60

  Change in 6MWD at Day 60

  Baseline to Day 60

Secondary Outcomes (5)

• Change in 6MWD at Day 30

  Baseline to Day 30

• Relief of symptoms on Day 30 and Day 60

  Baseline to Day 30 and Day 60

• Change in Pulmonary Function

  Baseline to Day 30 and Day 60

• Change in oxygenation

  Baseline to Day 30 and Day 60

• Change in biomarker levels

  Baseline to Day 60

Study Arms (2)

COVI-MSC

EXPERIMENTAL

Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)

Biological: COVI-MSC

Placebo

PLACEBO COMPARATOR

Excipient

Biological: Placebo

Interventions

COVI-MSC BIOLOGICAL

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

COVI-MSC

Placebo BIOLOGICAL

6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04