Pirfenidone + Upadacitinib for Post-COVID Syndrome

Recruiting at 7 trial locations

Overseen By Stephanie Perkin

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Douglas D. Fraser

Must not be taking: JAK inhibitors, Taurine, others

Disqualifiers: Pregnancy, Liver dysfunction, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two existing drugs, pirfenidone and upadacitinib, to determine if they can alleviate symptoms of Long Covid. Long Covid occurs when symptoms such as fatigue, breathing difficulties, memory issues, muscle pain, or circulation problems persist for at least three months after a Covid-19 infection. Participants must have experienced Covid-19 and currently suffer from Long Covid symptoms to join. The study compares the effects of these drugs to a placebo (a pill with no active ingredient) to assess their effectiveness and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does list certain supplements and medications that are prohibited. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that pirfenidone is safe for patients. It is approved for treating idiopathic pulmonary fibrosis, a lung disease, and has been tested in patients with lung issues after COVID. One study found that three months of treatment with pirfenidone was safe and effective for patients with lung problems following COVID, suggesting it is well-tolerated in similar conditions.

Upadacitinib is an approved medication for other conditions, indicating it has been tested for safety in humans. Although specific safety data for upadacitinib in Long Covid is not available here, its approval for other uses suggests it is generally safe. Overall, the approval of both pirfenidone and upadacitinib for other conditions provides reassurance about their safety for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pirfenidone and Upadacitinib for post-COVID syndrome because they target the condition in unique ways compared to standard treatments. Pirfenidone, traditionally used for pulmonary fibrosis, has antifibrotic properties that may help mitigate lung scarring and inflammation caused by lingering COVID-19 effects. Upadacitinib, on the other hand, is a JAK inhibitor that modulates the immune response, potentially reducing chronic inflammation. This dual approach of addressing both fibrosis and inflammation could offer relief where current treatments, primarily supportive care and symptom management, fall short.

What evidence suggests that this trial's treatments could be effective for Long Covid?

Research has shown that pirfenidone, one of the treatments in this trial, yields promising results for treating post-COVID-19 lung scarring, where lung tissue becomes stiff and scarred. Studies found that taking pirfenidone for 3 months improved lung function and was safe for patients.

Upadacitinib, another treatment option in this trial, blocks certain signals in the immune system that cause inflammation. Some reports suggest it might alleviate symptoms like joint pain and other immune-related issues in people recovering from COVID-19. While neither treatment is approved specifically for Long Covid yet, their success in similar conditions offers hope for symptom relief. ^{1 4 5 6 7}

Who Is on the Research Team?

Douglas D Fraser, MD, PhD, FRCPC

Principal Investigator

Western University

Are You a Good Fit for This Trial?

Adults from various countries who had Covid-19 and have been experiencing Long Covid symptoms like fatigue, breathing issues, memory problems, muscle/joint pain, or circulation issues for at least three months. They must be able to follow the study procedures.

Inclusion Criteria

My memory, thinking, or communication skills are affected.

I can and will follow the study's procedures.

I had COVID-19 confirmed by a test and have long COVID symptoms a year later.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either upadacitinib, pirfenidone, or placebo for three months

12 weeks

Follow-up Phase 1

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Phase 2

Continuation of testing the most effective drug(s) or new combinations based on Phase 1 results

Follow-up Phase 2

Participants are monitored for safety and effectiveness after Phase 2 treatment

What Are the Treatments Tested in This Trial?

Interventions

• Pirfenidone
• Upadacitinib

Trial Overview The LC-REVITALIZE trial is testing if repurposed drugs (upadacitinib or pirfenidone) can improve Long Covid symptoms compared to a placebo. It's an adaptive study that may change based on early results and includes two phases with different participant groups.

How Is the Trial Designed?

Group I: Upadacitinib Experimental Treatment 1 Intervention

15 mg upadacitinib tablets, over encapsulated in hard-gelatin capsules

Group II: Pirfenidone Experimental Treatment 1 Intervention

267mg pirfenidone tablets, over encapsulated in hard-gelatin capsules

Group III: Placebo for Pirfenidone Placebo Group 1 Intervention

Hard-gelatin capsules that are made to look and feel like the pirfenidone over encapsulated drug

Group IV: Placebo for Upadacitinib Placebo Group 1 Intervention

Hard-gelatin capsules that are made to look and feel like the upadacitinib over encapsulated drug

Who Is Running the Clinical Trial?

Douglas D. Fraser

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12018760/

Pirfenidone in post-COVID-19 pulmonary fibrosis (FIBRO ... The present study formally evaluated the efficacy and safety of treatment with pirfenidone versus placebo over a period of 24 weeks in patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123002500

Prolonged-release pirfenidone in patients with pulmonary ... In patients with PASC pulmonary fibrosis, three months' treatment with PR-PFD was safe and showed therapeutic efficacy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04607928

NCT04607928 | Pirfenidone Compared to Placebo in Post- ... The study population will be patients with fibrosing lung sequelae after recovery from severe COVID19 pneumonia. This is a double-blind, masked, placebo- ...

4. ijidonline.com ijidonline.com/article/S1201-9712(24)00264-9/fulltext

Impact of anti-fibrotic medications on post-COVID-19 ... Anti-fibrotic medications may help reduce fibrotic lesions and improve pulmonary function in post-COVID-19 pulmonary fibrosis.

5. resmedjournal.com resmedjournal.com/article/S0954-6111(23)00250-0/abstract

Prolonged-release pirfenidone in patients with pulmonary ... A 3-month treatment with a PFD in post-COVID-19 pulmonary fibrosis was tested. •. The treatment was safe and clinically effective, but the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04653831

Treatment With Pirfenidone for COVID-19 Related Severe ... The objective of the trial is to evaluate the safety and efficacy of treatment with Pirfenidone vs SoC in COVID-19 induced severe Acute Respiratory Distress ...

7. publications.ersnet.org publications.ersnet.org/content/erj/62/suppl67/OA3282.full

Pirfenidone in post-covid19 pulmonary fibrosis (FIBRO-COVID) Aims and Objectives: To evaluate the efficacy and safety profile of pirfenidone in subjects who present clinical-radiological signs of pulmonary fibrosis after ...