Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06928272

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

Led by Douglas D. Fraser · Updated on 2026-04-03

348

Participants Needed

9

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Confirmed or probable previous Covid-19 infection within the past four years
  • Persistent or new Long Covid symptoms lasting at least three months, diagnosed by a healthcare professional or investigator
  • Currently experiencing at least one of these symptoms: fatigue, breathing difficulties, circulation problems, memory/thinking/communication issues, or muscle/joint pain
  • Ability and willingness to follow study procedures
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Pregnant, lactating, or planning pregnancy during the study
  • Unwilling or unable to use contraception if of childbearing potential
  • Males not agreeing to use contraception to prevent pregnancy during and 30 days after the study
  • Severe kidney or liver dysfunction
  • Low hemoglobin, neutrophil, lymphocyte, or platelet counts outside specified limits
  • High cholesterol or LDL levels above specified thresholds
  • History or evidence of long QT syndrome or prolonged QT interval on ECG
  • Diagnosis of HIV, active hepatitis B or C, or recent active herpes zoster infection
  • Active or latent tuberculosis
  • Immunocompromised status posing unacceptable risk
  • Active cancer or lymphoproliferative disorder not in remission for at least five years
  • Positive Covid-19 test or symptoms within 30 days before enrollment
  • Previous ICU admission for acute Covid-19
  • History of major cardiovascular events or recent severe infections
  • Use of study drugs or JAK inhibitors within 30 days before enrollment
  • Known allergies to study drugs
  • Use of prohibited medications or supplements as listed
  • Recent Covid-19 vaccination or live vaccine administration
  • Major surgery within 30 days before enrollment or planned during the study
  • Any medical condition or therapy affecting safety or study compliance
  • Participation in another clinical study within 30 days
  • Participation in Phase One of this study
  • Currently hospitalized or incarcerated

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Laura Rodriguez Research Institute

San Diego, California, United States, 92101

Actively Recruiting

2

Ini-Fiocruz

Rio de Janeiro, Rio de Janerio, Brazil, 21040-900

Actively Recruiting

3

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, Canada, H2W 1R7

Actively Recruiting

4

Centre de Recherche du CHUS (CRCHUS)

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

5

INMI Lazzaro Spallanzani IRCCS

Roma, Roma, Italy, 00149

Not Yet Recruiting

6

Sapienza Università di Roma

Roma, Roma, Italy, 00185

Not Yet Recruiting

7

Università degli Studi di Modena e Reggio Emilia

Modena, Italy, 41124

Not Yet Recruiting

8

Joint Clinical Research Centre (JCRC)

Kampala, Kampala, Uganda, 10005

Not Yet Recruiting

9

University Teaching Hospital

Lusaka, Lusaka Province, Zambia, 10100

Not Yet Recruiting

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Research Team

S

Stephanie Perkin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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