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COMPLETED
NCT06128967
PHASE3

A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial

Sponsor: Cardresearch

View on ClinicalTrials.gov

Summary

IRB approval date 14-APR-2024 and public at https://plataformabrasil.saude.gov.br/login.jsf since IURB approval Long COVID is a multi-systemic condition comprising often severe and persistent symptoms (longer than 12 weeks) that follow a known episode of COVID-19 and cannot be explained by another medical condition. This condition is observed in up to 15% of all individuals after an acute episode of COVID-19, even in those who had a mild and oligosymptomatic SARS-CoV-2 infection. Around 40% of these patients present symptoms that significantly compromise their daily activities. There is increasing evidence that LONG COVID is accompanied by dysregulated, persistent and uncontrolled inflammation, often accompanied by the development of an autoreactive immune response, including autoantibodies. Symptoms can last months or years, particularly in cases of chronic fatigue syndrome, with significant proportions of individuals having significant chronic impairment, preventing the performance of work and social activities.

Official title: An Adaptive, Randomized, doublE-blind, Placebo-controlled, Prospective, Pharmacological interVention Study In Participants With Long COVID-19 Syndrome: REVIVE-TOGETHER Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

399

Start Date

2023-10-18

Completion Date

2025-08-01

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Fluvoxamine Maleate 100 MG

Fluvoxamine Maleate 100 mg each pills

DRUG

Placebo

Placebo talc pills of same shape, color, weight if compared with active comparator

DRUG

Metformin Extended Release Oral Tablet

Metformin Extended release oral tablets of 750 mg each pill

Locations (6)

CARDRESEARCH - Cardiologia Assistencial e de Pesquisa

Belo Horizonte, Minas Gerais, Brazil

City of Brumadinho

Brumadinho, Minas Gerais, Brazil

Governador Valadares City Public Health Authority

Governador Valadares, Minas Gerais, Brazil

City of Ibirité Public Health Authority

Ibirité, Minas Gerais, Brazil

Sociedade Padrao de Educacao Superior

Montes Claros, Minas Gerais, Brazil

Universidade Federal de Ouro Preto

Ouro Preto, Minas Gerais, Brazil