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

NCT04909892 | Withdrawn Phase 2 FDA Drug

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

Brief Summary

This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

Conditions

Covid19

Keywords

covid-19; 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 (4)

• Change in 6MWD at Day 30

  Baseline to Day 30

• Change in Pulmonary Function Tests (PFTs)

  Baseline to Day 30 and Day 60

• Change in oxygenation

  Baseline to Day 30 and Day 60

• Change in biomarker levels

  Baseline through Day 30

Study Arms (2)

COVI-MSC 1 vial

EXPERIMENTAL

Subjects will receive intravenous infusions of COVI-MSC (one vial, \~18.5 million cells) on Day 0, Day 2, and Day 4.

Biological: COVI-MSC

COVI-MSC 2 vials

EXPERIMENTAL

Subjects will receive intravenous infusions of COVI-MSC (two vials, \~37 million cells) on Day 0, Day 2, and Day 4.

Biological: COVI-MSC

Interventions

COVI-MSC BIOLOGICAL

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

COVI-MSC 1 vial; COVI-MSC 2 vials

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
• 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 2, 2021
• Study Start: August 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09