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RECRUITING
NCT06928272
PHASE3

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

Sponsor: Douglas D. Fraser

View on ClinicalTrials.gov

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.

Official title: LC-REVITALIZE - A Long Covid Repurposed Drug Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2025-09-10

Completion Date

2027-12

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Pirfenidone

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)

DRUG

Placebo 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

DRUG

Upadacitinib

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

DRUG

Placebo 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