Covid-19 living Data

Telmisartan vs Standard care (RCT)

Hospitalized patients

FOREST PLOTS -2021-07-02

Studies description

Trial NCT04355936
Publication Duarte M, EClinicalMedicine (2021) (published paper)
Dates: 14/05/2020 to 30/10/2020
Funding: Mixed (School of Medicine, University of Buenos Aires, Argentina; Laboratorio Elea Phoenix S.A.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Argentina Follow-up duration (days): 30
Inclusion criteria	Participants who were 18 years of age or older and who had been hospitalized with PCR-confirmed Covid-19 infection with 4 or fewer days elapsed since symptom onset.
Exclusion criteria	Admission to Intensive Care Unit (ICU) prior to randomization, illness symptoms beginning more than 4 days prior to randomization, pregnancy, breast feeding, major hypersensibility to ARBs, systolic blood pressure < 100mmHg, serum potassium greater than 5.5 mEq/L, AST and/or ALT > 3 times the upper limit of normal, serum creatinine higher than 3 mg/dL, treatment with angiotensin converting enzyme inhibitor (ACEi) or ARB at admission.
Interventions
	Treatment Telmisartan 80 mg orally twice a day for 14 days
	Control Standard care
Participants
	Randomized participants : Telmisartan=80 Standard care=82
	Characteristics of participants N= 162 Mean age : NR 84 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Primary outcome
	In the register C reactive protein [ Time Frame: Days 5 and 8 after enrollment ]
	In the report Reductions of C reactive protein levels at day 5 and 8 after randomization
Documents avalaible	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 published article, all available versions of the pre-print article, the study registry, protocol and supplementary appendix were used in data extraction and risk of bias assessment. The study was stopped early. Quote: "The first patient underwent randomization on May 14, 2020. No patients were enrolled after October 30th because of a sharp reduction in cases in Ciudad Autonoma de Buenos Aires, Argentina; Follow up finished on November 30th. At this stage, a pragmatic decision to end the study was made." There is no change from the trial registration in the intervention and control treatments. There were some changes in the inclusion and exclusion criteria, as well as primary and secondary outcomes between the registry and published report.