Covid-19 Living Data

Trial NCT04350580; EudraCT2020-001570-30
Publication ICAR - Mazeraud A, Lancet Respir Med (2021) (published paper)
Dates: 2020-04-03 to 2020-10-20
Funding: Public/non profit (Programme Hospitalier de Recherche Clinique; French ministry of Health; Laboratoire Français du fractionnement et des Biotechnologies)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / France Follow-up duration (days): 90
Inclusion criteria	Critically ill patients ≥18 years With COVID-19 confirmed by a positive PCR test Admitted to the intensive care unit Required invasive mechanical ventilation for moderate-to-severe ARDS, according to the Berlin Definition criteria Enrolled in the study within 72 h after starting invasive mechanical ventilation Written informed consent, in accordance with local legislation, was obtained from all patients or their surrogates. If written informed consent could not be obtained, patients were included because the study was considered an emergency research by the institutional review board, consent was obtained as soon as the patients were able to provide it.
Exclusion criteria	Acute renal failure at admission, defined as plasma creatinine above 354 μmol/L, an increase in plasma creatinine baseline concentration by three-times or more, a diuresis of less than 0·3 mL/kg over the last 24 h, or anuria over the last 12 h Pregnancy Immunoglobulin A deficit Allergy to IVIG Participation in another intervention trial
Interventions
	Treatment IV Ig Four intravenous perfusions of 0.5g/kg each given over at least 8 h over 4 days
	Control Placebo
Participants
	Randomized participants : Placebo=77 IV Ig=69
	Characteristics of participants N= 146 Mean age : NR 103 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=146 Number of vaccinated participants: NR
Primary outcome
	In the register Ventilator-free days [ Time Frame: 28 days ]
	In the report Number of ventilator-free days at day 28, defined as the number of days between the last extubation day and day 28.
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 protocol, statistical analysis plan, supplementary material and study registry were used in data extraction and risk of bias assessment. The study (n=146) achieved the target sample size specified in the trial registry (n=138). There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. This study was updated on March 16th, 2022 with data extracted after contact with authors.