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

Conditions

• Long COVID

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Pirfenidone — DRUG
  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)
• Placebo for pirfenidone — DRUG
  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
• Upadacitinib — DRUG
  1 capsule (15 mg), once daily for 3 months
• Placebo for upadacitinib — DRUG
  1 capsule, once daily for 3 months

Study Details

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.

Key Dates

Start date

Sep 10, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

348 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pirfenidone
  267mg pirfenidone tablets, over encapsulated in hard-gelatin capsules
• Placebo Comparator: Placebo for Pirfenidone
  Hard-gelatin capsules that are made to look and feel like the pirfenidone over encapsulated drug
• Experimental: Upadacitinib
  15 mg upadacitinib tablets, over encapsulated in hard-gelatin capsules
• Placebo Comparator: Placebo for Upadacitinib
  Hard-gelatin capsules that are made to look and feel like the upadacitinib over encapsulated drug

Primary Outcome Measure

Symptom Burden Questionnaire (SBQ) Subscales [ Time Frame: The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1. ]

Central Contacts

• Stephanie Perkin
  1-519-685-8500
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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