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.
This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
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
Change in Pulmonary Function Tests (PFTs)
Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)
Time frame: Baseline to Day 30 and Day 60
Change in oxygenation
Change in oxygenation at Days 30 and 60, as measured using 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 through Day 30
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