RECOVER-SLEEP: Platform Protocol

Korábbi kezelés

• Known history of narcolepsy prior to SARS-CoV-2 infection
• Any non-marijuana illicit drug use within 30 days of informed consent
• 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*
• Known contraindication(s) to study intervention including prohibited concomitant medications and without the ability to safely hold prohibited concomitant medications (see appendices)*
• Currently receiving/using intervention from another clinical trial that could impact or mask treatment effect; refer to MOP for details

Más betegség

• Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
• Known history of severe mental disorder, such as psychotic disorders and bipolar disorder
• Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control*
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • (*)If only one study intervention appendix is open at the time of enrollment. If multiple study intervention appendices are open, a participant may be excluded from any study intervention appendix based on contraindications listed in the study intervention appendix, current use of study intervention, or known allergy/sensitivity/hypersensitivity yet remain eligible for the remaining study intervention appendices.

Egyéb

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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

• In order to be eligible to participate in this study, an individual must meet all of the following 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:
  • Suspected* case of SARS-CoV-2 infection - Three options, A through C:
  • Met the clinical OR epidemiological criteria:
  • 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.
  • Probable* case of SARS-CoV-2 infection, defined as having met the clinical criteria above AND was a contact of a probable or confirmed case or is linked to a COVID-19 cluster; or
  • Confirmed case of SARS-CoV-2 infection - Two options, A through B:
  • Presented with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Met clinical criteria AND/OR epidemiological criteria (See suspected case A), with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
  • Suspected and probable cases will only be allowed if they occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
• 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**
  • ** Screening with both the PROMIS 8a SRI and 8b SD will occur for the phenotype assessment portion of the protocol.
• Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits
• Adequate method of birth control for participants of child-bearing potential