Covid-19 Living Data

Trial NCT04264533
Publication Zhang J, Ann. Intensive Care (2021) (published paper)
Dates: 14/02/2020 to 29/03/2020
Funding: Public/non profit (Science and Technology Department of Hubei Province; Fundamental Research Funds for the Central Universities)
Conflict of interest: No

Methods
	RCT Blinding: Participants, outcome assessor and health care pro
	Location : Multicenter / China Follow-up duration (days): 28
Inclusion criteria	(1) age ≥18 and <80 years (2) RT-PCR positive for SARS-CoV-2 (3) pneumonia confirmed by chest imaging and admission to the ICU within 48 hours of ICU admission, informed consent was obtained from the patients or their family members.
Exclusion criteria	Allergy to vitamin C, pregnancy or breastfeeding, expected survival duration <24 hours, and previous history of glucose-PaO2/FiO2(P/F)>300 mmHg allergy to vitamin C, pregnancy or breastfeeding, expected survival duration <24 hours, and previous history of glucose-6-phosphate dehydrogenase deficiency or end-stage pulmonary disease. Patients who were already enrolled in other clinical trials were excluded as well. When the patients actual treatment time was less than 3 days due to death or discharge from the ICU, they were removed from this trial.
Interventions
	Treatment Vitamin C 12 mg diluted in 50 mL of bacteriostatic water IV every 12h at a rate of 12 mL/hour for 7 days
	Control Placebo
Participants
	Randomized participants : Vitamin C=27 Placebo=29
	Characteristics of participants N= 56 Mean age : NR 37 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=* Number of vaccinated participants: NR
Primary outcome
	In the register Ventilation-free days [ Time Frame: on the day 28 after enrollment ]
	In the report IMV- free days in 28 days
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 study report, the study protocol, the pre-print article and the study registry were used in data extraction and risk of bias assessment. The study was terminated early. Quote: "With the control of the epidemic, this trial was stopped early, and the number of qualifying COVID-19 patients did not satisfy the anticipated sample size(140)" There is no change from the trial registration in the intervention and control treatments. The primary outcome in the registry matches that in the report. Some secondary outcomes specified in the registry (Demand for first aid measurements and APACHE II scores) were not specified in the pre-print report. The inverse is also true as some secondary outcomes in the report were not present in the registry (organ functions and inflammatory parameters, patient condition improvement rate, patient condition deterioration rate). This preprint was updated on 23/09/2020 and again on 20/01/2021 using the published report.