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Completed

NCT Number: NCT05513560

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ibudilast

Drug

10mg pills, 2 pills twice per day

Other names: MN-166

Pentoxifylline

Drug

400mg pill 3 times per day

Placebo

Other

Placebo matching ibudilast, 2 pills twice per day OR placebo matching pentoxifylline 1 pill 3 time per day.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Symptoms scale

    Time frame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.

    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.

  2. Symptom Checklist

    Time frame: Baseline/Randomization weekly to 2 months, then once monthly to 6 months.

    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.

  3. Six Minute Walking Test (6MWT) with oximetry

    Time frame: Baseline/Randomization and 2 months

    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.

  4. TestMyBrain cognitive testing

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  5. Post COVID19 functional status scale

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  6. Reintegration to Normal Living Index (RNLI)

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  7. Fatigue Scale

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  8. Brief Fatigue inventory

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  9. Post-Exertional Malaise

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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).

  10. Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  11. Mental Health - General Anxiety Assessment Form (GAD-7)

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  12. Mental Health - Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  13. Mental Health Composite score (MCS) of the SF-36

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  14. Dyspnea

    Time frame: Baseline/Randomization to 1, 2 months 3 and 6 months

    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.

  15. Blood samples

    Time frame: Baseline/Randomization and 2 months

    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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)

Acronym: RECLAIM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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