Long COVIDPhase 2/3RECLAIMNCT05513560
RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine
A Phase 2/3 study testing Ibudilast and Pentoxifylline in people with Long COVID and Post COVID Condition, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Post COVID Condition, Post Acute Sequelae of COVID-19
- What is being tested?
- Ibudilast and Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 3 sitesCanada
- Study dates
- 31 May 2023to 31 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
- 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.
- 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;
- Lingering symptoms from COVID-19 present at the time of randomization.
- Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
- Must be able to provide informed consent and both willing and able to comply with study requirements.
Who cannot join
- Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- Contraindications to all of the study interventions;
- Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
- Currently pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Ottawa Hospital
Ottawa, Ontario
University Health Network, Osteoporosis Department
Toronto, Ontario, M5G 2C4
Mount Sinai Hospital
Toronto, Ontario
About this study
Official title: REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)
The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.
Interventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.
- Being tested
- Ibudilast, Pentoxifylline, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbudilastDrug
Also called MN-166
10mg pills, 2 pills twice per day
PentoxifyllineDrug
400mg pill 3 times per day
PlaceboOther
Placebo matching ibudilast, 2 pills twice per day OR placebo matching pentoxifylline 1 pill 3 time per day.
| Study group | Role | What they receive |
|---|---|---|
| IBUDILAST | Experimental | Participants will receive 20 mg dose (2 pills) twice per day taken by mouth. Receives: Drug: Ibudilast |
| PENTOXIFYLLINE | Experimental | Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth. Receives: Drug: Pentoxifylline |
| PLACEBO | Placebo comparator | Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 physical component score (PCS)
mean change in the SF-36 (v.1) physical component score (PCS)
Measured: from baseline to two months
Secondary outcomes (15)
Symptoms scale
Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.
Measured: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
Symptom Checklist
Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.
Measured: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
Six Minute Walking Test (6MWT) with oximetry
Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards.
Measured: Baseline/Randomization and 2 months
TestMyBrain cognitive testing
TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Post COVID19 functional status scale
The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Reintegration to Normal Living Index (RNLI)
This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Fatigue Scale
The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Brief Fatigue inventory
The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Post-Exertional Malaise
The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions).
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a validated, reliable, 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual 5 (DSM-5) symptoms of Post-Traumatic Stress Disorder (PTSD). It takes approximately 5-10 minutes to complete.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - General Anxiety Assessment Form (GAD-7)
The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.
The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-9 can also be administered repeatedly, which can reflect improvement or worsening of depression in response to treatment.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health Composite score (MCS) of the SF-36
The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Dyspnea
Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.
Measured: Baseline/Randomization to 1, 2 months 3 and 6 months
Blood samples
Blood samples will be used in correlative studies using advanced multi-omic and machine learning methods to better understand our results so as to identify phenotypes that will benefit from specific therapies
Measured: Baseline/Randomization and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start31 May 2023
- Primary completion31 Mar 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RECLAIM is a Canada-wide phase ll/lll, prospective, adaptive randomized controlled platform trial that is intended to study various interventions for patients with long COVID. Interventional arms may be discontinued based on interim analysis results and new interventions may be selected and included as part of the platform as the trial progresses. As such, the protocol and consent documents are a modular design including; * Master Protocol and informed consent documents: Contain information applicable to the whole platform. * Interventional Sub-Protocols: Contain additional information, specific to the interventional arm. Interventional Sub-Protocols may be modified, discontinued, or added without revisions to the Master Protocol.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela M Cheung, MD,PhD, Principal investigator, University Health Network, TorontoGeorge Tomlinson, PhD, Principal investigator, University Health Network, TorontoPeter Juni, MD, PhD, Principal investigator, Oxford University, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513560
- Sponsor's protocol ID
- 21-6203
- Acronym
- RECLAIM
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)
- ClinicalTrials.gov ID
- NCT05513560
- Acronym / sponsor ID
- RECLAIM / 21-6203
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.
Interventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- RECLAIM is a Canada-wide phase ll/lll, prospective, adaptive randomized controlled platform trial that is intended to study various interventions for patients with long COVID. Interventional arms may be discontinued based on interim analysis results and new interventions may be selected and included as part of the platform as the trial progresses. As such, the protocol and consent documents are a modular design including; * Master Protocol and informed consent documents: Contain information applicable to the whole platform. * Interventional Sub-Protocols: Contain additional information, specific to the interventional arm. Interventional Sub-Protocols may be modified, discontinued, or added without revisions to the Master Protocol.
| Arm | Type | Receives |
|---|---|---|
| IBUDILAST | Experimental | Drug: IbudilastParticipants will receive 20 mg dose (2 pills) twice per day taken by mouth. |
| PENTOXIFYLLINE | Experimental | Drug: PentoxifyllineParticipants will receive a 400mg dose (1 pill) 3 times per day taken by mouth. |
| PLACEBO | Placebo comparator | Other: PlaceboParticipants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
- 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.
- 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;
- Lingering symptoms from COVID-19 present at the time of randomization.
Key exclusion criteria (5 listed)
- Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- Contraindications to all of the study interventions;
- Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
- Currently pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbudilastAlso: MN-16610mg pills, 2 pills twice per day | Drug | IBUDILAST |
| Pentoxifylline400mg pill 3 times per day | Drug | PENTOXIFYLLINE |
| PlaceboPlacebo matching ibudilast, 2 pills twice per day OR placebo matching pentoxifylline 1 pill 3 time per day. | Other | PLACEBO |
Primary outcome
SF-36 physical component score (PCS)
Time frame: from baseline to two months
mean change in the SF-36 (v.1) physical component score (PCS)
15 secondary outcomes
Symptoms scale
Time frame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
Symptom Checklist
Time frame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.
Six Minute Walking Test (6MWT) with oximetry
Time frame: Baseline/Randomization and 2 months
TestMyBrain cognitive testing
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Post COVID19 functional status scale
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Fatigue Scale
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Brief Fatigue inventory
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Post-Exertional Malaise
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - General Anxiety Assessment Form (GAD-7)
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health - Patient Health Questionnaire (PHQ-9)
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Mental Health Composite score (MCS) of the SF-36
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Dyspnea
Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months
Blood samples
Time frame: Baseline/Randomization and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Cheung, MD,PhD principal investigator
University Health Network, Toronto
George Tomlinson, PhD principal investigator
University Health Network, Toronto
Peter Juni, MD, PhD principal investigator
Oxford University, UK
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ibudilast and Pentoxifylline in people with Long COVID and Post COVID Condition, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 physical component score (PCS) (time frame: from baseline to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.