The RECLAIM (REcovering from COVID‑19 Lingering symptoms Adaptive Integrative Medicine) trial
We propose to develop a Canada-wide, open-label, pragmatic, adaptive randomized clinical trial platform to assess the effectiveness of various interventions in patients with lingering symptoms of COVID‑19 (« long COVID »). After a run-in period, participants will be randomized using an adaptive randomization scheme (that favors more promising therapies and discontinues ineffective ones, allowing new interventions to be introduced and tested) to receive either standard of care (control) or the study intervention. This trial will have 4 arms. An Interdisciplinary Science Committee will determine and prioritize interventions to be tested. The top three choices will be used in our four arm study, with the fourth arm being standard of care for symptomatic treatment. Potential interventions include immunomodulatory therapies (e.g. pegylated alpha-interferon), antivirals, monoclonal antibodies, anti-inflammatory (e.g. colchicine), anti-platelet agents (e.g. aspirin), fluvoxamine, and traditional Chinese medicine, among others. Interventions will last for 4 weeks and participants will be followed for 12 weeks. Approximately 800-1000 patients with « long COVID » will be recruited across Canada. Inclusion criteria include patients age>16, with confirmed COVID‑19 and lingering symptoms that have lasted over 3 months. A concerted effort will be made to recruit a study population that is diverse in terms of age, sex, gender, race, ethnicity and comorbid conditions. Primary outcome: the validated Post-COVID-19 Functional Status scale (PCFS). Secondary outcomes: symptom checklists, De Paul Symptom Questionnaire 2, health-related quality of life (SF-36), 6 minute walk test, and re-integration to normal living. 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 ».
