LC-REVITALIZE - A Long Covid Repurposed Drug Study
Douglas D. Fraser
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.
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligible participants must meet all the following inclusion criteria: 1. Adults ≥ 18 years of age and ≤ 65 years of age 2. Previous Covid-19 (SARS-CoV-2 infection) within the past four years, as determined by the site investigator using the following certainty scale (based on available clinical history and/or serologic data): 3 - Confirmed Infection (PCR or n-Capsid Test): Prior positive nasopharyngeal or salivary PCR test for Covid-19 (documented proof and/or verbal confirmation by participant) or has positive nucleocapsid antibodies results. 2 - Probable Infection (An…
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 InstituteSan Diego, California
- Ini-FiocruzRio de Janeiro, Rio de Janerio
- Institut de Recherches Cliniques de Montréal (IRCM)Montreal, Quebec
- Centre de Recherche du CHUS (CRCHUS)Sherbrooke, Quebec
- INMI Lazzaro Spallanzani IRCCSRoma, Roma
- Sapienza Università di RomaRoma, Roma