fluvoxamine for COVID-19: living meta-analysis of clinical studies

TOGETHER, 2021 NCT04727424

fluvoxamine (n=741) vs. placebo (n=756)

randomized controlled trial

Studied treatment

Fluvoxamine
100mg twice daily for 10 days.

Control treatment

Placebo
Twice daily for 10 days.

All participants received usual standard care for COVID-19 provided by healthcare professionals workers at public health facilities. Clinicians providing usual care in public health facilities typically focus on the management of symptoms and with antipyretics, and recommend antibiotics only if they suspect bacterial pneumonia.

Patients

COVID 19 outpatients

Patients over 18 years old with the ability to provide free and informed consent with Acute Flu-Like symptoms < 07 days and at least ONE enhancement criteria (Age > 50 years; Diabetes mellitus requiring oral medication or insulin Systemic arterial hypertension requiring at least 01 oral medication for BP control; Known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies) Symptomatic lung disease (emphysema, chronic bronchitis) Symptomatic asthma patients requiring chronic use of agents for control of symptoms. Fever > 38 C at baseline Obesity, defined as BMI> 30 kg / m2 body weight Transplanted patients Patient with stage IV chronic kidney disease or on dialysis. Immunosuppressed patients/ using corticosteroid therapy (equivalent to maximum 10 mg of prednisone per day) and/ or immunosuppressive therapy) Patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer Chronic renal disease KDIGO IV or End-Stage Renal Disease on chronic ambulatory renal replacement therapy Patients with important limitation of daily activities due to: Dyspnea, chest pain myalgia (limited to 25% of all randomizations) ). Patient with positive rapid test for SARS-CoV2 antigen performed on occasion of the screening or patient with a positive SARS-CoV2 diagnostic test within 07 days of the onset of symptoms.

Method

Double-blind.

10 sites in Minas Gerais, Brazil.

Bayesian analysis.

Remark

Some inconsistencies between preprint and publication in terms of population size and inclusion period.

Lenze (STOP COVID 1), 2020 NCT04342663

COVID-OUT (fluvoxamine), 2022 NCT04510194

TOGETHER, 2021 NCT04727424

ACTIV-6, 2022 NCT04885530