NCT06128967

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Cardresearch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is currently no approved therapies for Long COVID. Several clinical trials have been developed to address this clinical condition, however the results were based on small-scale pilot studies. We developed this adaptive, large-scale, prospective, double-blind clinical trial to evaluate the effect of chronic immune-inflammatory modulation on persistent Long-COVID symptoms.

Conditions

• Long COVID-19 Syndrome
• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2023-11-13
• Last updated: 2026-04-13

Locations

6 sites across 1 country: Brazil