Covid-19 Living Data

Trial ChiCTR2000029757
Publication Li L, JAMA, 2020 (published paper)
Dates: 2020-02-14 to 2020-04-01
Funding: Public/non profit (Chinese Academy of Medical Sciences InnovationFund for Medical Sciences (CIFMS) grants2020-I2M-CoV19-006, 2016-I2M-3-024 (Dr Z. Liu),and 2017-I2M-1-009 (Dr L. Li) and the NonprofitCentral Research Institute Fund of ChineseAcademy of Medical Scie)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / China Follow-up duration (days): 28
Inclusion criteria	(1) signed informed consent; (2) aged at least 18 years; (3) COVID-19 diagnosis based on polymerase chain reaction (PCR) testing; (4) positive PCR result within 72 hours prior to randomization; (5) pneumonia confirmed by chest imaging; (6) clinical symptoms meeting the definitions of severe or life-threatening COVID-19; (7) acceptance of random group assignment; (8) hospital admission; (9)willingness to participate in all necessary research studies and be able to complete the study follow-up; and (10) no participation in other clinical trials, such as antiviral trials, during the study period.
Exclusion criteria	(1) pregnancy or lactation; (2) immunoglobulin allergy; (3) IgA deficiency; (4) preexisting comorbidity that could increase the risk of thrombosis; (5) life expectancy less than 24 hours; (6) disseminated intravascular coagulation; (7) severe septic shock; (8) PaO2/ FIO2 of less than 100; (9) severe congestive heart failure; (10) detection of high titer of S protein–RBD-specific (receptor binding domain) IgG antibody (≥1:640); (11) other contraindications as determined by the patient’s physicians; and (12) participation in any antiviral clinical trials for COVID-19 within 30 days prior to enrollment.
Interventions
	Treatment Convalescent plasma 4-13 mL/kg IV once off at 10 mL for the first 15 minutes, then increased to 100 mL per hour.
	Control Standard care Definition of Standard care: Standard treatment consisted of symptomatic control and supportive care for COVID-19, mostly based on the evolving Chinese national COVID-19 treatment guidelines and hospital practice.12 Possible treatments included antiviral medications, antibacterial medications, steroids, human immunoglobulin, Chinese herbal medicines, and other medications.
Participants
	Randomized 103 participants (n₁=52 / n₂= 51)
	Characteristics of participants N=103 Mean age : NR 60 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=45 Critical: n=58
Primary outcome
	In the register The number of days between randomised grouping and clinical improvement
	In the report Time to clinical improvement within 28 days
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 all available versions of the published/pre-print article, the study registry, protocol, and statistical analysis plan 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 primary outcome in the report reflects the primary outcome indicated in the registry. The containment of the pandemic in Wuhan led to a decrease in new Covid-19 cases. This did not permit the study to reach its recruitment target. After discussion with the expert committee of the Institute of Blood Transfusion, the study was terminated on 1/4/20 by the sponsor (Chinese Academy ofMedical Sciences) and the leading primary investigator on April 1, 2020. Some analyses (e.g., clinical improvement rates) were not pre-specified. Some pre-specified secondary outcomes are not reported in the paper (e.g., duration of ECMO). The authors report only adverse events related to plasma convalescent therapy.