A Phase 2 interventional study of COVI-MSC and Placebo in Covid19, sponsored by Sorrento Therapeutics, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Sorrento Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →Sorrento Therapeutics, Inc. is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
Biological: COVI-MSC
Excipient
Biological: Placebo
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
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
Change in 6-Minute Walk Distance (6MWD) at Day 60
Change in 6MWD at Day 60
Time frame: Baseline to Day 60
Change in 6MWD at Day 30
Change in 6MWD at Day 30
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Day 30 and Day 60
Change in biomarker levels
Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
Time frame: Baseline to Day 60
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Sorrento Therapeutics, Inc.