Covid-19 Living Data

Trial NCT04311177
Publication Puskarich M, EClinicalMedicine (2021) (published paper)
Dates: 2020-04-09 to 2020-11-30
Funding: Public/non profit (Minnesota Partnership for Biotechnology and Medical Genomics)
Conflict of interest: No

Methods
	RCT Blinding: Participants, outcome assessor and health care pro
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Positive clinical SARS-CoV-2 result at least 18 years old symptomatic within 24 hours of informed consent (any CDC recognized symptom)
Exclusion criteria	More than 7 days of symptoms already taking an ACE-inhibitor or ARB prior adverse reactions to those medications pregnant or breastfeeding unwilling to use contraception or abstain from sex history of dialysis stage IV chronic kidney disease estimated eGFR <30 ml/min/1.73 m2 potassium >5.0 mmol/L reported severe dehydration or reduced urine output over the prior 72 hours history of cirrhosis, hepatitis B or C, or other severe liver disease expected to impair study drug metabolism prescribed aliskiren measured systolic blood pressure of <110 mmHg at randomization enrolled in another blinded randomized clinical trial for COVID-19 unable to provide informed consent
Interventions
	Treatment Losartan 25 mg orally twice daily (eGFR >60 mL/min/1.73 m2) or once daily (eGFR 30-60 mL/min/1.73 m2) for 10 days
	Control Placebo
Participants
	Randomized participants : Losartan =58 Placebo=59
	Characteristics of participants N= 117 Mean age : NR 59 males Severity : Mild: n= 117/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Hospital Admission [ Time Frame: 15 days ]
	In the report All-cause hospitalization within 15 days
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	Low
General comment	In addition to the pre-print article, the prospective trial registry was used in data extraction and risk of bias assessment. The trial was terminated early by the investigators due to low event rates, logistical challenges, and concern of more equitable allocation of potential study participants into larger national outpatient trial efforts more likely to identify an effective therapy. Consequently, the trial did not achieve the target sample size specified in the trial registry and several outcomes listed in the registry were not reported in the pre-print. However, the primary outcome (hospital admission) is the same in registry and report, and so are participant eligibility criteria and intervention- and control treatments. This trial was updated on July 1st, 2021 with data from the published journal report.