RECOVER-SLEEP: Platform Protocol

Completed · Phase 2 · Has a placebo group

Conditions studied: Long COVID, Long COVID-19, Hypersomnia, Sleep Disturbance

In brief

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).

Key facts

Study ID

NCT06404086

Run by

Duke University

People needed

830

Starts

2024-07-31

Expected to finish

2025-12-31

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A. 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:
• A. 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

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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*
• Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control*
• 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
• 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.

Where it is running

• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• University of Arizona Banner Medical Center — Tucson, Arizona, United States
• The Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Stanford University — Palo Alto, California, United States
• University of California San Francisco General Hospital — San Francisco, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine Jacksonville — Jacksonville, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Emory Hope Clinic — Decatur, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Cook County Health Specialty Care Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• NorthShore Medical Group — Evanston, Illinois, United States
• Saint Francis Medical Center — Peoria, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Jadestone Clinical Research, LLC — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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