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

NCT06128967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Long COVID-19 Syndrome
  • Chronic Fatigue Syndrome

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

Sponsors & Collaborators

  • Cardresearch

    lead OTHER

Principal Investigators

  • Gilmar Reis, MD,PhD. · Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-07-01
Completion
2025-08-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128967 on ClinicalTrials.gov