AzTrials
AzTrials

Long COVIDPhase 2NCT06404086

RECOVER-SLEEP: Platform Protocol

A Phase 2 study testing Modafinil, Solriamfetol and Melatonin in people with Long COVID and Long COVID-19, run by Duke University at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID, Long COVID-19, Hypersomnia
What is being tested?
Modafinil, Solriamfetol and Melatonin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
830 participants
Where
47 sitesUnited States
Study dates
31 Jul 2024to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87102

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Med. Ctr.

    Boston, Massachusetts, 02215

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Cook County Health Specialty Care Center

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45220

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Atlanta VA Medical Center

    Decatur, Georgia, 30030

  • Emory Hope Clinic

    Decatur, Georgia, 30030

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

  • NorthShore Medical Group

    Evanston, Illinois, 60201

  • East Carolina University

    Greenville, North Carolina, 27834

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • New Dawn Wellness and Medical Research Center

    Houston, Texas, 77082

  • University Physicians and Surgeons (DBA Marshall Health)

    Huntington, West Virginia, 25701

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Evergreen Hospital Medical Center

    Kirkland, Washington, 98034

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia, 26506

  • Rutgers University - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Stanford University

    Palo Alto, California, 94304

  • Saint Francis Medical Center

    Peoria, Illinois, 61606

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of California San Francisco General Hospital

    San Francisco, California, 94143

  • Jadestone Clinical Research, LLC

    Silver Spring, Maryland, 20904

  • University of Arizona Banner Medical Center

    Tucson, Arizona, 85719

  • The Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

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).

Read the detailed description

Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

After completing Baseline assessments, participants will be randomized to an intervention group, which is based on their sleep phenotype, or into a placebo/control group.

Being tested
Modafinil, Modafinil Placebo, Solriamfetol, Solriamfetol Placebo, Melatonin
Keywords
PASC
Medical subject headings
Post-Acute COVID-19 Syndrome, Disorders of Excessive Somnolence, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModafinilDrug

    Modafinil is used off-label based on supporting published evidence in major depressive disorder (antidepressant augmentation), multiple sclerosis-related fatigue, Parkinson disease-related excessive daytime sleepiness, and severe cancer-related fatigue (in patients receiving active treatment). Doses up to 400 mg/day, given as a singleMode dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose.

    Study drug administration will total 10 weeks.

  • Modafinil PlaceboDrug

    The placebo will be tooled to look similar to the modafinil tablet, but it will not contain the active ingredient. Modafinil placebo dosing will follow the same titration scheme as modafinil treatment.

    Unblinded study personnel will manage modafinil and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.

  • SolriamfetolDrug

    The proposed doses and the schedule of dose escalation are consistent with currently approved FDA labeling for solriamfetol for other disorders of excessive daytime sleepiness.

    Solriamfetol dosing will total 10 weeks, including 3 weeks for titration and 7 weeks of maintenance. Solriamfetol will be given as a 75 mg tablet (1 or 2 per day) in the morning. The 3-week titration will be facilitated by phone calls between the study team and participants. Titrations in dose will be dependent upon participants' symptoms and tolerance to solriamfetol, with a goal of participants taking the highest dose permitted by symptoms. This dose will be used for the maintenance phase.

  • Solriamfetol PlaceboDrug

    The placebo tablet will be tooled to look similar to the solriamfetol tablet, but it will not contain the active ingredient. Solriamfetol placebo dosing will follow the solriamfetol dosing scheme and goal.

    Unblinded study personnel will manage solriamfetol and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.

  • MelatoninDrug

    Melatonin dosing will be one tablet of 3 mg immediate release daily consumed 2 hours before the participant's desired bedtime, which is defined as the time at which the participant tries to fall asleep.

  • Melantonin PlaceboDrug

    Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime.

  • Tailored lighting (TL) ActiveDevice

    TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants.

  • Tailored lighting (TL) PlaceboDevice

    TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants.

Study groups in NCT06404086
Study groupRoleWhat they receive
Hypersomnia Arm (Appendix A)OtherThis is a double-blind, phase 2, randomized, placebo-controlled interventional trial of a wake-promoting drug (modafinil or solriamfetol) to treat hypersomnia, defined by elevated scores (> 55) on the PROMIS 8a SRI scale, in participants with PASC. Participants will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or modafinil-matched control. If modafinil is contraindicated, participants will be assessed for solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks. Anticipated enrollment is 474 participants. Details about the Hypersomnia Appendix are available under NCT06404099.
Receives: Drug: Modafinil; Drug: Modafinil Placebo; Drug: Solriamfetol; Drug: Solriamfetol Placebo
Complex PASC related Sleep Disturbances (CPSD) Arm (Appendix B )OtherThis is a double-blind, phase 2, randomized, placebo-controlled, interventional trial that combines brief education and a tailored sleep timing prescription for CPSD with therapies that modify circadian timing for participants who report poor sleep quality or daytime sleep-related impairment, defined by elevated scores (≥55) on the PROMIS 8b SD scale, in participants with symptoms that occurred or worsened after COVID-19 infection. Interventions involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to 1 of 4 groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive BBT-CPSD. It is a 2x2 factorial design schema. The intervention duration will be 8 weeks. Anticipated enrollment for this appendix is 600 participants. Additional details about the CPSD Appendix are available under NCT06404112.
Receives: Drug: Melatonin; Drug: Melantonin Placebo; Device: Tailored lighting (TL) Active; Device: Tailored lighting (TL) Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of participants enrolled in each Appendix

    Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start31 Jul 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This platform protocol is designed to allocate participants into an intervention appendix based on their symptoms of sleep disturbance. Within the appendix, participants will be randomly assigned based on the appendix study design. Site investigators and personnel will be informed as to which study intervention appendix participants are assigned, but they will be blinded to whether participants are receiving the active study intervention or control, when possible. Similarly, participants will be blinded to active intervention or control, when possible. Randomization will be stratified by the study site; other stratification factors may be considered per appendix.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404086
Sponsor's protocol ID
Pro00112484
Other IDs
OTA-21-015G
Status last verified
Jan 2026
First submitted
6 May 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: The summary of results will be shared on the study website: https://recovercovid.org/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modafinil, Solriamfetol and Melatonin in people with Long COVID and Long COVID-19, run by Duke University at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of participants enrolled in each Appendix (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06404086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in