Covid-19 Living Data

Trial NCT04333368, EudraCT 2020-001287-28
Publication Monsel A, Crit Care (2022) (published paper)
Dates: 2020-04-06 to 2020-10-29
Funding: Public/non profit (French Ministry of Health and the French National Research Agency)
Conflict of interest: No

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / France Follow-up duration (days): 28
Inclusion criteria	Age > 18 years reverse transcriptase–polymerase chain reaction -confirmed SARS–CoV-2 infection Berlin criteria-defined acute respiratory distress syndrome for < 96 h respiratory support (invasive or non-invasive mechanical ventilation, and/or high-flow nasal oxygenation) with positive end-expiratory pressure equivalent ≥ 5 cm H2O.
Exclusion criteria	Age < 18 years acute respiratory distress syndrome present for > 96 h pulmonary fibrosis pulmonary hypertension (WHO classification class III or IV) pulmonary embolism within the previous 3 months extracorporeal membrane oxygenation or life support immunocompromised status including use of immunosuppressive medications pregnancy or breastfeeding treatment for cancer in the past 2 years underlying medical condition with life expectancy < 6 months moderate-to-severe liver disease (Child–Pugh score > 12) severe chronic lung disease with the use of home oxygen and/or partial arterial pressure of carbon dioxide > 50 mm Hg patients not committed to full support (i.e., had do not resuscitate or limit life support orders) participation in another trial of COVID-19 therapeutics.
Interventions
	Treatment UC-MSC Three intravenous infusions of 10^6 UC-MSCs/kg (maximum dose set at 80 × 10^6 cells per infusion) or placebo on D1, D3 ± 1 and D5 ± 1.
	Control Placebo
Participants
	Randomized participants : UC-MSC=22 Placebo=25
	Characteristics of participants N= 47 Mean age : NR 37 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=14 Critical: n=31 Number of vaccinated participants: 0
Primary outcome
	In the register Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group
	In the report Respiratory improvement assessed as the partial pressure of oxygen to fractional inspired oxygen (PaO2/FiO2)-ratio change between baseline (D0) and D7 post-randomization.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Low
General comment	“In addition to the published article, the supplementary materials including protocol and study registry were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes from the registry are not reported in the paper (but these are not relevant to our review). Adverse events reported separately for before and after Day 14, so only those up to Day 14 were extracted due to potential patient overlap. The study (n=47) did not achieve the target sample size (n=60) specified in the trial registry."