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A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial
Sponsor: Cardresearch
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
Fluvoxamine Maleate 100 MG
Fluvoxamine Maleate 100 mg each pills
Placebo
Placebo talc pills of same shape, color, weight if compared with active comparator
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