RECOVER-SLEEP: Platform Protocol

Eligibility Criteria

• 1. ≥ 18 years of age at the time of enrollment
• 2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization:
• 1. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia;
• 2. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presented with acute respiratory infection with a history of fever or measured fever of ≥ 38°C and cough, with onset within the last 10 days, and required hospitalization; or C. Presented with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
• 3. New/worse sleep problems following a SARS-CoV-2 infection that have persisted for at least 12 weeks and are still present at the time of consent
• 4. PROMIS 8a SRI or 8b SD T Score ≥ 60\*\*
• 5. Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits
• 6. Adequate method of birth control for participants of child-bearing potential
• 1. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
• 2. Known pregnancy, breastfeeding, or contemplating pregnancy during the study period
• 3. Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)
• 4. Current night or rotating shift work
• 5. Known history of narcolepsy prior to SARS-CoV-2 infection
• 6. Any non-marijuana illicit drug use within 30 days of informed consent
• 7. Known history of severe mental disorder, such as psychotic disorders and bipolar disorder
• 8. Current or recent use (within the last 14 days) of study intervention or similar intervention to treat the underlying condition, unless a washout period is permitted per appendix\*
• 9. Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control\*
• 10. Known contraindication(s) to study intervention including prohibited concomitant medications and without the ability to safely hold prohibited concomitant medications (see appendices)\*
• 11. Currently receiving/using intervention from another clinical trial that could impact or mask treatment effect; refer to MOP for details
• 12. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study