Your session is about to expire
← Back to Search
Other
Ibudilast + Pentoxifylline for Long COVID (RECLAIM Trial)
Phase 2 & 3
Recruiting
Led By Angela M Cheung, 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
Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms
Must not have
Contraindications to all of the study interventions
Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to two months
Summary
This trial will test two treatments to find the best way to help people with long-term COVID-19 symptoms. It will adapt based on early results, stopping ineffective treatments and adding new ones as needed.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had COVID-19 symptoms for more than 3 months since I first got sick.
Select...
I still have symptoms from COVID-19.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot undergo any of the treatments offered in this study due to health reasons.
Select...
I was on a ventilator or ECMO for COVID-19 treatment.
Select...
I do not have organ failure, haven't had an organ transplant, and am not in the hospital.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
SF-36 physical component score (PCS)
Secondary study objectives
Blood samples
Brief Fatigue inventory
Dyspnea
+12 moreSide effects data
From 2017 Phase 2 trial • 125 Patients • NCT0186080750%
Headache
17%
Nausea
16%
Insomnia
13%
Diarrhea
2%
Suicide Attempt
2%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibudilast
Placebo
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
2016
Completed Phase 2
~410
Pentoxifylline
2021
Completed Phase 4
~1080
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-COVID Syndrome include anti-inflammatory medications, which reduce inflammation that may persist after the acute phase of COVID-19; antiviral drugs, which aim to eliminate any lingering viral particles; and supportive therapies like respiratory rehabilitation and corticosteroids, which help improve lung function and reduce symptoms. These treatments are important for Post-COVID Syndrome patients as they address the root causes of their persistent symptoms, potentially leading to better health outcomes and improved quality of life.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,275 Total Patients Enrolled
Angela M Cheung, MD,PhDPrincipal InvestigatorUniversity Health Network, Toronto
George Tomlinson, PhDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had COVID-19 symptoms for more than 3 months since I first got sick.I cannot undergo any of the treatments offered in this study due to health reasons.I have been on standard cancer treatment for at least 4 weeks.I was on a ventilator or ECMO for COVID-19 treatment.I do not have organ failure, haven't had an organ transplant, and am not in the hospital.I still have symptoms from COVID-19.You have tested positive for COVID-19 in the past three months, or you have symptoms of COVID-19 without a positive test since October 15, 2019.
Research Study Groups:
This trial has the following groups:- Group 1: IBUDILAST
- Group 2: PENTOXIFYLLINE
- Group 3: PLACEBO
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger