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Study of 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.

Purpose of Study

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.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

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

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)

Conditions:

COVID-19

Status:

Not yet recruiting

Phase:

Phase 2

Study ID

NCT04992247

Read Detailed Summary

Start Date / End Date:

01/07/2022 -

Enrollment:

60

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04992247

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