460 Participants Needed

Ibudilast + Pentoxifylline for Long COVID

(RECLAIM Trial)

Recruiting at 2 trial locations
SC
JS
JS
AM
Overseen ByAngela M Cheung, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University Health Network, Toronto
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be on standard of care therapies for at least 4 weeks before joining the trial.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients should be treated with standard of care therapies for at least 4 weeks before joining the trial, which suggests you may need to continue your current treatments.

What safety data is available for the treatment of Ibudilast + Pentoxifylline for Long COVID?

The provided research does not contain specific safety data for the combination of Ibudilast (also known as MN-166, AV-411, Ketas) and Pentoxifylline (also known as Trental) for Long COVID. The studies focus on whey protein and its effects, which are unrelated to the safety of Ibudilast and Pentoxifylline. Therefore, no relevant safety data for this treatment combination is available in the provided research.12345

Is the drug Ibudilast, Pentoxifylline, Placebo, Whey Protein Isolate promising for Long COVID?

The information provided does not include any relevant research articles or data about the effectiveness of Ibudilast, Pentoxifylline, Placebo, or Whey Protein Isolate for Long COVID. Therefore, we cannot determine if it is a promising treatment based on the given information.678910

How does the drug Ibudilast + Pentoxifylline for Long COVID differ from other treatments?

This drug combination is unique because it targets Long COVID, a condition with no standard treatment, using Ibudilast, which has anti-inflammatory properties, and Pentoxifylline, known for improving blood flow. This approach is novel compared to existing treatments that primarily focus on symptom management rather than addressing underlying inflammation and circulation issues.678910

What data supports the idea that Ibudilast + Pentoxifylline for Long COVID is an effective drug?

The available research does not provide direct evidence supporting the effectiveness of Ibudilast + Pentoxifylline for Long COVID. The studies focus on Pentoxifylline's effects in other conditions, such as cancer-related muscle wasting and multiple sclerosis. For example, Pentoxifylline has been shown to prevent muscle loss in cancer patients and improve treatment outcomes in multiple sclerosis when combined with another drug. However, these findings do not directly relate to Long COVID.1112131415

What data supports the effectiveness of the drug Ibudilast + Pentoxifylline for Long COVID?

Research shows that Pentoxifylline can prevent muscle wasting and has anti-inflammatory effects, which might help in conditions like Long COVID where inflammation and muscle issues are common.1112131415

Who Is on the Research Team?

PJ

Peter Juni, MD, PhD

Principal Investigator

Oxford University, UK

AM

Angela M Cheung, MD,PhD

Principal Investigator

University Health Network, Toronto

GT

George Tomlinson, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had COVID-19 symptoms for more than 3 months since I first got sick.
I have been on standard cancer treatment for at least 4 weeks.
I still have symptoms from COVID-19.
See 3 more

Exclusion Criteria

I cannot undergo any of the treatments offered in this study due to health reasons.
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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the interventions or placebo for 2 months

8 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks
Monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Ibudilast
  • Pentoxifylline
  • Placebo
  • Whey Protein Isolate
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: PENTOXIFYLLINEExperimental Treatment1 Intervention
Group II: IBUDILASTExperimental Treatment1 Intervention
Group III: PLACEBOPlacebo Group1 Intervention

Ibudilast is already approved in Japan, United States for the following indications:

🇯🇵
Approved in Japan as Ibudilast for:
🇺🇸
Approved in United States as MN-166 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

Pentoxifylline (PTX) effectively prevents muscle atrophy and reduces protein breakdown in cancer cachexia by inhibiting the activation of the ubiquitin-proteasome pathway, as demonstrated in a study with Yoshida sarcoma-bearing rats.
PTX is a well-tolerated drug in humans that could be valuable for cachectic patients, as it suppresses the effects of tumor necrosis factor, which is linked to muscle wasting in conditions like cancer, sepsis, and trauma.
Manipulation of the ubiquitin-proteasome pathway in cachexia: pentoxifylline suppresses the activation of 20S and 26S proteasomes in muscles from tumor-bearing rats.Combaret, L., Rallière, C., Taillandier, D., et al.[2019]
In a study of 50 patients undergoing long-term pentoxifylline therapy, 27 patients successfully weaned off the medication without experiencing symptomatic deterioration, indicating that long-term therapy can be safely reduced.
However, 60% of those who weaned successfully showed asymptomatic declines in walking performance, suggesting that while patients may not feel worse, their objective measures of claudication could still decline, which does not necessarily require resuming therapy.
Pentoxifylline therapy for chronic claudication: are patients dependent on therapy?Johnson, WC., Watkins, MT., Hamilton, J., et al.[2013]
In a study involving 70 patients with cancer-associated anorexia and cachexia, pentoxifylline did not improve appetite or weight gain, indicating it may not be effective for this condition.
The drug was well-tolerated and did not cause any toxicity, suggesting it is safe to use, but ultimately, it did not provide the expected therapeutic benefits.
Pentoxifylline for treatment of cancer anorexia and cachexia? A randomized, double-blind, placebo-controlled trial.Goldberg, RM., Loprinzi, CL., Mailliard, JA., et al.[2022]

Citations

Manipulation of the ubiquitin-proteasome pathway in cachexia: pentoxifylline suppresses the activation of 20S and 26S proteasomes in muscles from tumor-bearing rats. [2019]
Pentoxifylline therapy for chronic claudication: are patients dependent on therapy? [2013]
Pentoxifylline for treatment of cancer anorexia and cachexia? A randomized, double-blind, placebo-controlled trial. [2022]
PTX Treatment of Colon Cancer: Mode of Action Based on Tumor Marker and Cytokine Kinetics. [2022]
Synergistic immunomodulatory effects of interferon-beta1b and the phosphodiesterase inhibitor pentoxifylline in patients with relapsing-remitting multiple sclerosis. [2015]
Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283. [2022]
mTOR1c Activation with the Leucine "Trigger" for Prevention of Sarcopenia in Older Adults During Lockdown. [2022]
Inhibitory effect of whey protein concentrate on SARS-CoV-2-targeted furin activity and spike protein-ACE2 binding in methotrexate-induced lung damage. [2022]
Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Combined effect of dietary supplementation with pressurized whey and exercise training in chronic obstructive pulmonary disease: a randomized, controlled, double-blind pilot study. [2022]
Fluticasone furoate and vilanterol trifenatate combination therapy for the treatment of asthma. [2022]
Next generation beta adrenoreceptor agonists for the treatment of asthma. [2018]
▼Olodaterol--another LABA for COPD. [2016]
Double-blind trial of a long-acting bronchodilator preparation ("Nethaprin Dospan") in bronchospastic disease. [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security