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

Sorrento Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Covid19

Treatments: Biological: COVI-MSC; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04992247

MSC-PLH-201BR

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

COVI-MSC

Experimental group

Description:

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

Treatment:

Biological: COVI-MSC

Placebo

Placebo Comparator group

Description:

Excipient

Treatment:

Biological: Placebo