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Ibudilast + Pentoxifylline for Long COVID (RECLAIM Trial)

Phase 2 & 3

Recruiting

Led By Peter Juni, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline/randomization to 1, 2 months 3 and 6 months

Awards & highlights

RECLAIM Trial Summary

This trial will help researchers find the best interventions for patients with Long COVID. It is a Canada-wide trial that will last for 6 months and will include 800-1000 patients.

Who is the study for?

Adults over 18 with Long COVID symptoms persisting for more than 3 months since the earliest of a positive test or symptom onset, and who have been symptomatic for at least 2 months. Participants must have tried standard care therapies for 4 weeks, be able to consent, follow study rules, and if capable of childbearing, agree to use approved contraception methods. Excludes those who had severe COVID requiring mechanical ventilation or ECMO, current severe organ failure or transplant patients.Check my eligibility

What is being tested?

The RECLAIM trial is testing Ibudilast and Pentoxifylline against a placebo in Canadian patients with Long COVID. It's an adaptive trial that can modify its arms based on effectiveness results during the process. Treatment lasts two months with four additional months of follow-up to evaluate recovery from lingering symptoms.See study design

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include gastrointestinal discomfort, headaches, dizziness or fatigue. Since this is a trial setting, monitoring will be rigorous and any unexpected side effects will be documented.

RECLAIM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been on standard cancer treatment for at least 4 weeks.

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I have had COVID-19 symptoms for more than 3 months since I first got sick.

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I still have symptoms from COVID-19.

RECLAIM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline/randomization to 1, 2 months 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline/randomization to 1, 2 months 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/randomization to 1, 2 months 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SF-36 physical component score (PCS)

Secondary outcome measures

Blood samples

Brief Fatigue inventory

Dyspnea

+12 more

Side effects data

From 2017 Phase 2 trial • 125 Patients • NCT01860807

50%

Headache

17%

Nausea

16%

Insomnia

13%

Diarrhea

Suicide Attempt

Convulsion

100%

80%

60%

40%

20%

Study treatment Arm

Ibudilast

Placebo

RECLAIM Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: PENTOXIFYLLINEExperimental Treatment1 Intervention

Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth.

Group II: IBUDILASTExperimental Treatment1 Intervention

Participants will receive 20 mg dose (2 pills) twice per day taken by mouth.

Group III: PLACEBOPlacebo Group1 Intervention

Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibudilast

2013

Completed Phase 2

~340

Pentoxifylline

2021

Completed Phase 4

~1140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

483,490 Total Patients Enrolled

Peter Juni, MD, PhDPrincipal InvestigatorOxford University, UK

Angela M Cheung, MD,PhDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Ibudilast (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05513560 — Phase 2 & 3

Post-COVID Syndrome Research Study Groups: IBUDILAST, PENTOXIFYLLINE, PLACEBO

Post-COVID Syndrome Clinical Trial 2023: Ibudilast Highlights & Side Effects. Trial Name: NCT05513560 — Phase 2 & 3

Ibudilast (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513560 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still receiving applications for this experiment?

"The clinicaltrials.gov website indicates that this trial is not currently recruiting patients. This particular study was posted on September 1st, 2022 and was last updated on September 12th, 2022. There are 1136 other trials enrolling patients at the moment."

Answered by AI

Who else is applying?

What site did they apply to?

University Health Network, Osteoporosis Department

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I am in desperate need of help with long Covid. I am 25 years old and it has ruined my ability to function as I did prior to being afflicted with Covid in January of 2021.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine

2023. "RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05513560.

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