RecruitingPhase 3NCT06928272

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

LC-REVITALIZE - A Long Covid Repurposed Drug Study


Sponsor

Douglas D. Fraser

Enrollment

348 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pirfenidone, a drug called Placebo for pirfenidone, and others for people with long covid. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirfenidone

Initial dose titration: First week (days 1-7): 1 capsule (267 mg), 3 times daily (801 mg/day) Second week (days 8-14): 2 capsules (534 mg), 3 times daily (1602 mg/day) Maintenance dose: Third week and thereafter (days 15+): 3 capsules (801 mg), 3 times daily (2403 mg/day)

DRUGPlacebo for pirfenidone

First week (days 1-7): 1 capsule, 3 times daily Second week (days 8-14): 2 capsules, 3 times daily Third week and thereafter (days 15+): 3 capsules, 3 times daily

DRUGUpadacitinib

1 capsule (15 mg), once daily for 3 months

DRUGPlacebo for upadacitinib

1 capsule, once daily for 3 months


Locations(9)

Laura Rodriguez Research Institute

San Diego, California, United States

Ini-Fiocruz

Rio de Janeiro, Rio de Janerio, Brazil

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, Canada

Centre de Recherche du CHUS (CRCHUS)

Sherbrooke, Quebec, Canada

INMI Lazzaro Spallanzani IRCCS

Roma, Roma, Italy

Sapienza Università di Roma

Roma, Roma, Italy

Università degli Studi di Modena e Reggio Emilia

Modena, Italy

Joint Clinical Research Centre (JCRC)

Kampala, Kampala, Uganda

University Teaching Hospital

Lusaka, Lusaka Province, Zambia

View Full Details on ClinicalTrials.gov

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NCT06928272


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