NCT06928272

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

LC-REVITALIZE - A Long Covid Repurposed Drug Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Douglas D. Fraser · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Long Covid represents a significant public health challenge, yet effective treatments remain elusive due to the disease's heterogeneity, limited clinical data, and inconsistent methodologies. A previous analysis of clinical and proteomic data from 1,028 subjects diagnosed with Long Covid across three continents (The LC-Optimize Study) suggests that certain repurposed medications may offer potential therapeutic benefits. Drug repurposing is based on the principle that many drugs interact with multiple molecular targets and mechanisms of action, potentially extending their effects beyond their original intended use. This phenomenon arises from the complex nature of biological systems and the interactions between drugs and various cellular components, which our research pipeline is designed to identify. A key advantage of repurposed drugs is that they already have established safety and toxicity profiles, are approved by regulatory authorities, and can therefore expedite clinical trials with sufficient supporting data and justification. This is a Phase III, double-blind, placebo-controlled, multi-arm platform study that will enroll participants from Brazil, Canada, Italy, Uganda, Zambia, and the United States. The first phase of the study will enroll approximately 348 participants globally, all of whom must have previously tested positive for SARS-CoV-2 and have been experiencing Long Covid symptoms for three months or more. A second phase will follow, guided by the results of the first phase and determined through an interim analysis. This phase, which will occur after a protocol amendment, may involve continued testing of one or both repurposed drugs, combination treatments with an additional repurposed drug, or the introduction of a completely new repurposed drug.

Conditions

• Long COVID

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-04-15
• Last updated: 2026-04-03

Locations

9 sites across 6 countries: United States, Brazil, Canada, Italy, Uganda, Zambia

Regulatory

• FDA-regulated drug study