Covid-19 Living Data

Trial NCT04252274
Publication Chen J, Open Forum Infect Di, 2020 (published paper)
Dates: 30jan2020 to 06feb2020
Funding: Public/non profit (Ministry of Science and Technology of China; the Shanghai Science and Technology Committee; Shanghai Major Projects on Infectious Diseases; and the Shanghai )
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / China Follow-up duration (days): 14
Inclusion criteria	All the participants had laboratory-confirmed SARS-CoV-2 infection and were willing to participate the study, as evidenced by signing an informed consent.
Exclusion criteria	Participants were excluded if they met any of the following criteria: hypersensitivity to darunavir, cobicistat, or any excipients; patients with severe liver injury (Child-Pugh Class C); patients receiving concomitant medications that are highly dependent on cytochrome P450 3A clearance, and for which the elevated plasma concentrations are associated with serious or life-threatening events; subjects considered to be unable to complete the study (eg, severely and critically ill patients) or not suitable for the study by researchers. Patients who met any of the following criteria were classified as severe cases: respiratory rate 30 times/min, pulse oxygen saturation 93% at resting, or ratio between partial pressure of oxygen in arterial blood and fraction of inspired oxygen (PaO2/ FiO2) 300 mmHg. Critical illness was defined as respiratory failure that needed mechanical ventilation or shock or exacerbation of any comorbidity that required transfer to the intensive care unit.
Interventions
	Treatment Darunavir/cobicistat Darunavir: 800 mg orally once per day for 5 days Cobicistat: 150 mg orally once per day for 5 days
	Control Standard care Definition of Standard care: All the participants received interferon alpha 2b and standard of care as per guideline recommendation in China
Participants
	Randomized 30 participants (n₁=15 / n₂= 15)
	Characteristics of participants N=30 Mean age : 47.2 18 males Severity : Mild: n=0 / Moderate: n=30/ Severe: n=0 Critical: n=0
Primary outcome
	In the register The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
	In the report The primary end point was viral clearance rate at day 7 after randomization.
Documents available	Protocol NR Statistical plan NR Data-sharing stated NR
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	High
General comment	In addition to all available versions of the published/pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size reported in the registry. There is no change from the trial registration in the intervention and control treatments. All outcomes from the registry are reported in the paper. No protocol or pre-specified statistical analysis plan are available. The study claimed both ITT and PP analysis were conducted, but only ITT outcome analysis are reported. Safety analysis was performed. No information on total adverse events. All adverse events were mild.