Covid-19 living Data

Tenofovir + Emtricitabine vs Standard care (RCT)

Hospitalized patients

FOREST PLOTS -2022-11-18

Studies description

Trial NCT04359095
Publication Gaitan-Duarte H, eClinicalMedicine (2021) (published paper)
Dates: 2020-08-24 to 2021-03-20
Funding: Public/non profit (Colombian Ministry of Science and Technology, Universidad Nacional de Colombia, and Pontificia Universidad Javeriana)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Colombia Follow-up duration (days): 28
Inclusion criteria	Adults 18 years of age Clinical picture of COVID-19 infection diagnosed by real-time polymerase chain reaction (RT−PCR) or viral antigen testing and with mild, moderate or severe pneumonia requiring inhospital treatment: Mild pneumonia was defined based on chest X-ray findings plus 2 or more risk factors for COVID-19 complications, including age over 60 years, pre-existing cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), or cancer. Moderate pneumonia was defined based on X-ray findings, such as, bilateral air-space consolidation, usually ground glass opacities with peripheral and basal distribution, in accordance with local guidelines and hospitalization criteria on the simplified severity scale (CRB-65) > 1 or ambient oxygen saturation under 90%. Severe pneumonia was defined using the same criteria as for moderate pneumonia plus any of the following Respiratory rate of more than 30 breaths per minute Or the need for mechanical ventilation (invasive or non-invasive) Or sepsis identified by a score of 2 or more on the Sequential Organ Failure Assessment (SOFA) scale Or 2 out of 3 of a Glasgow score of 13 or less, systolic blood pressure of 100 mmHg or less, and respiratory rate of 22 breaths per minute or higher, or a diagnosis of septic shock or multiple organ failure or adult respiratory distress syndrome
Exclusion criteria	Pregnant women Patients taking any of the study medications in the last 7 days or with known allergy to them History of myopathy or rhabdomyolysis Hepatic, or renal failure Lung fibrosis Advanced or metastatic cancer Those with score more than 3 on the frailty scale
Interventions
	Treatment Tenofovir/Emtricitabine Tenofovir: 300 mg orally once daily for 10 days Emtricitabine: 200 mg orally once daily for 10 days CLC+ROSU Colchicine: 0.5 mg orally twice daily for 14 days Rosuvastatin: 40 mg orally once daily for 14 days EMT/TNF+CLC+ROSU Tenofovir: 300 mg orally once daily for 10 days Emtricitabine: 200 mg orally once daily for 10 days Colchicine: 0.5 mg orally twice daily for 14 days Rosuvastatin: 40 mg orally once daily for 14 days
	Control Standard care
Participants
	Randomized participants : Tenofovir/Emtricitabine=163 CLC+ROSU=161 EMT/TNF+CLC+ROSU=163 Standard care=162
	Characteristics of participants N= 649 Mean age : NR 428 males Severity : Mild: n=109 / Moderate: n=418 / Severe: n=57 Critical: n=49
Primary outcome
	In the register Mortality [ Time Frame: Post-intervention at day 28 ] Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection [ Time Frame: Post-intervention at day 28 ] Number of participants that develop severe adverse events related to the treatment
	In the report All-cause mortality within 28 days after after treatment assignment; Severe adverse events
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 pre-print article, the protocol, statistical analysis plan and the prospective registry were used in data extraction and assessment of risk of bias. There were no major differences between the outcomes planned in the registry and those in the report. The study did not achieve its target sample size. The study was updated on the March 2nd, 2022 with data extracted from the published report.