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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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
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