Covid-19 Living Data

Trial NCT04288102
Publication Shi L, eBioMedicine (2022) (published paper)
Dates: 2020-03-05 to 2021-03-31
Funding: Public/non profit (The National Key R&D Program of China; The Innovation Groups of the National Natural Science Foundation of China; The National Science and Technology Major Project)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / China Follow-up duration (days): 90
Inclusion criteria	severe COVID-19 diagnosed after onset of disease chest computed tomography (CT) imaging confirmed pneumonia combined with lung damage. The illness severity of COVID-19 was evaluated in accordance with Guidelines issued by the National Health Commission of China (version 7.0). Briefly, patients with any of the following conditions but without invasive ventilation, shock or other organ failure (need organ support therapy) were considered as severe cases: dyspnoea (respiratory rate ≥ 30 times/min) oxygen saturation of 93% or lower on room air arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) ≤ 300 mmHg pulmonary imaging showing that the foci progressed by > 50% in 24-48 hours.
Exclusion criteria	Shock or COVID-19 combined with any one of other organ failures, those who received invasive ventilation, or patients with any malignant tumour, pregnancy or breastfeeding, or co-infection of other pathogens
Interventions
	Treatment hUC-MSC 4.0x10^7 MSCs in a volume of 100 mL, infused on days 0, 3 and 6.
	Control Placebo
Participants
	Randomized participants : hUC-MSC=66 Placebo=35
	Characteristics of participants N= 101 Mean age : NR 56 males Severity : Mild: n=24 / Moderate: n=75 / Severe: n=1 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Change in lesion proportion (%) of full lung volume from baseline to day 28
	In the report change in the total lesion proportion (%) of the whole lung volume from baseline to day 28, as measured by chest CT
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	Some concerns
General comment	In addition to the published/pre-print article, the trial registry, study protocol, supplementary materials and statistical analysis plan were used in data extraction and assessment of risk of bias. Originally planned as a Phase 1 study, the study progressed to Phase 2 with an expanded sample size due to satisfactory assessment of safety. The study exceeded its original and amended sample sizes. Changes were made to primary outcome measure in the trial registry both during and after study conduct, but this is reported along with the reasons in the pre-print article. Some outcomes from the registry/protocol are not reported in the paper (e.g., time to clinical improvement). This study was updated on March 19th, 2021 using data from the published manuscript (Signal Transduction). This study was updated on March 22nd, 2022 using 1-year follow-up data from the published manuscript (eBioMedicine)