Covid-19 Living Data

Trial NCT04328012
Publication COVID MED - Freilich D, medRxiv (2022) (preprint)
Dates: 2021-04-06 to 2021-05-27
Funding: Public/non profit (Bassett Research Institute and Bassett Medical Center’s Department of Internal Medicine)
Conflict of interest: No

Methods
	RCT Blinding: quadruple blinding
	Location : Single center / USA Follow-up duration (days): 60
Inclusion criteria	Hospitalized >18 years-old laboratory-confirmed SARS-CoV-2 infection randomization within 72 hours of admission able to provide consent
Exclusion criteria	End-stage renal disease severe hepatic insufficiency nausea/vomiting/aspiration risk precluding oral medications unless can be given by nasogastric tube use of another SARS-CoV-2 medication pregnancy/breast feeding no contraception inability to obtain consent ARB allergy/intolerance taking ACEi/ARB hypotension hyperkalemia severe renal dysfunction severe volume depletion/AKI ascites aortic/mitral stenosis renal artery stenosis co-administration of CYP3A interacting drugs
Interventions
	Treatment Losartan Initially 25 mg orally twice daily; changed to 25 mg orally once daily (after other treatment arms stopped) for up to 14 days
	Control Placebo
Participants
	Randomized participants : Losartan =9 Placebo=4
	Characteristics of participants N= 13 Mean age : NR 8 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS) [Time Frame: 60 days]
	In the report Improvement in the 7-point COVID-19 Ordinal Scale Score (COSS)
Documents available	Protocol NR Statistical plan NR 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 preprint article, the study registry was used in data extraction and risk of bias assessment. Neither the protocol nor the statistical analysis plan was available. The sample size is very low; the study stopped early due to low enrollment and did not reach the target sample size (n=100)."