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

NCT06928272 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-04-03

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Douglas D. Fraser

    lead OTHER

Principal Investigators

  • Douglas D Fraser, MD, PhD, FRCPC · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Italy
  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06928272 on ClinicalTrials.gov