Long COVIDPhase 2NCT06404112

RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

A Phase 2 study testing Melatonin and Tailored lighting (TL) Active in people with Long COVID and Long COVID-19, run by Duke University at 1 site 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, Sleep Disturbance
What is being tested?: Melatonin and Tailored lighting (TL) Active
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 469 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2024to 1 Apr 2026
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

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Who cannot join

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix
Additional Appendix B (CPSD) Level Inclusion Criteria:
The following additional exclusion criteria are to be considered together for determining eligibility. They are separated here by TL and melatonin only for presentation. RESET-PASC presents no additional exclusions.
TAILORED LIGHTING EXCLUSION CRITERIA
Severe visual impairments affecting sensitivity or ability to respond to light
Severe photosensitivity dermatitis

Show all 11Show fewer

Severe progressive retinal disease, eg, macular degeneration
Permanently dilated pupil, eg, following certain cataract surgeries
Unwilling to remove or not wear blue-light-blocking glasses during TL dosing
MELATONIN EXCLUSION CRITERIA
1. Sleep medication, if not willing to washout for 4 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

All sites listed under NCT06404086
Durham, North Carolina, 27710

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)

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.

Conditions: Long COVID, Long COVID-19, Sleep Disturbance
Being tested: Melatonin, Melantonin Placebo, Tailored lighting (TL) Active, Tailored lighting (TL) Placebo
Keywords: PASC, Sleep Disturbances
Medical subject headings: Post-Acute COVID-19 Syndrome, Parasomnias

What participants receive

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

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 NCT06404112
Study group	Role	What they receive
Active TL + Oral Melatonin	Active comparator	The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks. Receives: Drug: Melatonin; Device: Tailored lighting (TL) Active
Active TL + Placebo Melatonin	Active comparator	The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks. Receives: Drug: Melantonin Placebo; Device: Tailored lighting (TL) Active
Placebo TL + Oral Melatonin	Active comparator	The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks. Receives: Drug: Melatonin; Device: Tailored lighting (TL) Placebo
Placebo TL + Placebo Melatonin	Placebo comparator	The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks. Receives: Drug: Melantonin Placebo; Device: Tailored lighting (TL) Placebo

What is being measured

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

Change in total score of the PROMIS 8b SD to assess sleep disturbance
The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.
Measured: Baseline, End of Intervention (Day 63)
Change in sleep onset variability, assessed using a wearable device
A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI
Measured: Baseline, End of Intervention (Day 63)

Secondary outcomes (14)

Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with > 55 1 SD above population mean.
Measured: Baseline, End of Intervention (Day 63)
Change in PROMIS 10a Fatigue score
The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).
Measured: Baseline, End of Intervention (Day 63)
Change in an objective neurocognitive battery score
Measured: Baseline, End of Intervention (Day 63)
Change in ECog2 measure
Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.
Measured: Baseline, End of Intervention (Day 63)
Change in PASC Symptom Questionnaire responses
Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.
Measured: Baseline, End of Intervention (Day 63)
Change in total score from ISI (Insomnia Severity Index)
The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.
Measured: Baseline, End of Intervention (Day 63)
Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary
Sleep onset time will be assessed by sleep diary
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary
Nocturnal sleep duration will be assessed by sleep diary
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary
24-hour sleep duration will be assessed by sleep diary
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary
Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker
Nocturnal sleep duration will be assessed by activity tracker
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker
24-hour sleep duration will be assessed by activity tracker
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker
Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker
Measured: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker
Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary
Measured: Baseline, End of Intervention (Day 63)

Timeline

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

31 Jul 20241 Apr 2026

First posted8 May 2024
Study start31 Jul 2024
Primary completion26 Feb 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Long COVIDStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 469 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06404112
Sponsor's protocol ID: Pro00112484_B
Other IDs: OTA-21-015G
Status last verified: Jan 2026
First submitted: 6 May 2024
Last updated: 8 Jul 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
ClinicalTrials.gov ID: NCT06404112
Acronym / sponsor ID: Pro00112484_B
Conditions: Long COVID, Long COVID-19, Sleep Disturbance
Keywords: PASC, Sleep Disturbances
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 469 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 31 Jul 2024 (actual)
Primary completion: 26 Feb 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 8 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
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.

Arm	Type	Receives
Active TL + Oral Melatonin	Active comparator	Drug: Melatonin, Device: Tailored lighting (TL) ActiveThe Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks.
Active TL + Placebo Melatonin	Active comparator	Drug: Melantonin Placebo, Device: Tailored lighting (TL) ActiveThe Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks.
Placebo TL + Oral Melatonin	Active comparator	Drug: Melatonin, Device: Tailored lighting (TL) PlaceboThe Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks.
Placebo TL + Placebo Melatonin	Placebo comparator	Drug: Melantonin Placebo, Device: Tailored lighting (TL) PlaceboThe Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four 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 RESET-PASC. The intervention duration will be 8 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Key exclusion criteria (11 listed)

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix
The following additional exclusion criteria are to be considered together for determining eligibility. They are separated here by TL and melatonin only for presentation. RESET-PASC presents no additional exclusions.
TAILORED LIGHTING EXCLUSION CRITERIA
Severe visual impairments affecting sensitivity or ability to respond to light
Severe photosensitivity dermatitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MelatoninMelatonin 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.	Drug	Active TL + Oral Melatonin, Placebo TL + Oral Melatonin
Melantonin PlaceboMelatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime.	Drug	Active TL + Placebo Melatonin, Placebo TL + Placebo Melatonin
Tailored lighting (TL) ActiveTL 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.	Device	Active TL + Oral Melatonin, Active TL + Placebo Melatonin
Tailored lighting (TL) PlaceboTL 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.	Device	Placebo TL + Oral Melatonin, Placebo TL + Placebo Melatonin

Primary outcome

Change in total score of the PROMIS 8b SD to assess sleep disturbance
Time frame: Baseline, End of Intervention (Day 63)
The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.
Change in sleep onset variability, assessed using a wearable device
Time frame: Baseline, End of Intervention (Day 63)
A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI

14 secondary outcomes

Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
Time frame: Baseline, End of Intervention (Day 63)
Change in PROMIS 10a Fatigue score
Time frame: Baseline, End of Intervention (Day 63)
Change in an objective neurocognitive battery score
Time frame: Baseline, End of Intervention (Day 63)
Change in ECog2 measure
Time frame: Baseline, End of Intervention (Day 63)
Change in PASC Symptom Questionnaire responses
Time frame: Baseline, End of Intervention (Day 63)
Change in total score from ISI (Insomnia Severity Index)
Time frame: Baseline, End of Intervention (Day 63)
Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 63)
Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 63)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. The summary of results will be shared on the study website: https://recovercovid.org/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina Barkauskas, MD study chair

Duke Clinical Research Institute

Susan Redline, MD MPH study chair

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melatonin and Tailored lighting (TL) Active in people with Long COVID and Long COVID-19, run by Duke University at 1 site 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 1 inclusion and 11 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Change in total score of the PROMIS 8b SD to assess sleep disturbance (time frame: Baseline, End of Intervention (Day 63)). The study lists 2 primary outcomes in all. 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 NCT06404112.

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 8 Jul 2026.