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Phase 3Completed

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

Sponsor
Cardresearch (Academic or other)
Enrolment
399 enrolled
Conditions
Long COVID-19 Syndrome; Chronic Fatigue Syndrome
Interventions
Fluvoxamine Maleate 100 MG; Placebo; Metformin Extended Release Oral Tablet
Ages
adults, older adults
Registry
NCT06128967

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Improvement on Fatigue Severity Score Scale (FSS)

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Registered

  5. Started

Papers citing this trial