The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.
This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 years of age at the time of enrollment
✓. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization:
✓. 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;
✓. 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.
✓. 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
✓. PROMIS 8a SRI or 8b SD T Score ≥ 55\*\*
✓. Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits
✓
What they're measuring
1
Total number of participants enrolled in each Appendix
. Adequate method of birth control for participants of child-bearing potential
Exclusion criteria
✕. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
✕. Known pregnancy, breastfeeding, or contemplating pregnancy during the study period
✕. Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)
✕. Current night or rotating shift work
✕. Known history of narcolepsy prior to SARS-CoV-2 infection
✕. Any non-marijuana illicit drug use within 30 days of informed consent
✕. Known history of severe mental disorder, such as psychotic disorders and bipolar disorder
✕. 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\*