RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine
- Conditions
- Post Acute Sequelae of COVID-19Post COVID ConditionLong COVID
- Interventions
- Registration Number
- NCT05513560
- Lead Sponsor
- University Health Network, Toronto
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PLACEBO Placebo Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth. IBUDILAST Ibudilast Participants will receive 20 mg dose (2 pills) twice per day taken by mouth. PENTOXIFYLLINE Pentoxifylline Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth.
- Primary Outcome Measures
Name Time Method SF-36 physical component score (PCS) from baseline to two months mean change in the SF-36 (v.1) physical component score (PCS)
- Secondary Outcome Measures
Name Time Method Reintegration to Normal Living Index (RNLI) 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.
Fatigue Scale 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.
Post-Exertional Malaise 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).
Mental Health - Patient Health Questionnaire (PHQ-9) 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.Symptoms scale 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.
Post COVID19 functional status scale 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.
Symptom Checklist 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.
Dyspnea 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.
Blood samples 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
Six Minute Walking Test (6MWT) with oximetry 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.
TestMyBrain cognitive testing 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.
Brief Fatigue inventory 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.
Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5) 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.
Mental Health - General Anxiety Assessment Form (GAD-7) 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.
Mental Health Composite score (MCS) of the SF-36 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.
Trial Locations
- Locations (3)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
University Health Network, Osteoporosis Department
🇨🇦Toronto, Ontario, Canada