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

ConditionLong COVID
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDouglas D. Fraser

About this trial

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.

Eligibility criteria

Qualifiers

Adults ≥ 18 years of age and ≤ 65 years of age

Fatigue

Breathing

Circulation

Disqualifiers

Participants who do not meet the criteria outlined above

Participants who are unable to provide their informed consent

Participants who are pregnant, lactating, or plan to become pregnant during the time of the study

Persons of childbearing potential who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening through at least 30 days after the end of the study intervention period. Acceptable methods include barrier contraceptives (e.g., condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about the risks related to pregnancy or breastfeeding will also be excluded.

Trial design

Treatments tested in this trial

  • Pirfenidone
  • Placebo for pirfenidone
  • Upadacitinib
  • Placebo for upadacitinib

Treatment groups

348 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Douglas D. Fraser

Lead sponsor

Western University, Canada

Sponsor institution