Post COVID-19 ConditionNCT05658536
The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19
A study testing 6-Week Self-Management Group in people with Post COVID-19 Condition and Post-COVID-19 Syndrome, run by University of Washington at 1 site in United States.
Trial summary
This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition, Post-COVID-19 Syndrome
- What is being tested?
- 6-Week Self-Management Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 30 Jan 2024
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Resident of Washington state
- Diagnosis of a Post-COVID condition
- Able to read, speak, and understand English
- Availability of a telephone and internet access
Who cannot join
- Severe cognitive impairment
- Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Ninth and Jefferson Building
Seattle, Washington, 98104
About this study
Official title: The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID
This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
Read the detailed description
Post-acute sequelae SARS-CoV-2 infection (PASC), also referred to as Post-COVID, is an emerging condition with debilitating symptoms relevant to rehabilitation medicine. Post-COVID has been described as the "next national health disaster". The Centers for Disease Control and Prevention describe Post COVID as a wide range of physical and mental health symptoms lasting four or more weeks after SARS-CoV-2 infection. Some of the most common and disabling symptoms include, fatigue, memory issues, pain-related symptoms, insomnia, and shortness of breath. In addition to these physical symptoms, many patients with Post-COVID report co-occurring mental health concerns, including anxiety and depression. It is believed that over 100 million people worldwide currently experience or have experienced Post COVID. Importantly, this condition can be debilitating and disabling - nearly one in five people reported not working as a direct result of Post COVID.
Psychosocial self-management interventions are a promising treatment for helping people with Post COVID manage their symptoms and engage in adaptive coping. Unfortunately, there is currently no cure for Post COVID, and it is unclear at what timepoint patients will recover or what proportion of patients will recover. Given the variability and chronicity of Post COVID symptoms, self-management interventions could be particularly beneficial. Research on patient populations with similar symptom profiles as Post COVID (e.g., myalgic encephalomyelitis, multiple sclerosis) suggests that psychosocial interventions like self-management can reduce symptom severity and interference and improve coping.
This randomized controlled pilot trial will use quantitative and qualitative methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
The study objectives include:
- To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID.
- To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping.
- To understand intervention participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of the Post-COVID intervention and their recommendations for improving the intervention.
- Conditions
- Post COVID-19 Condition, Post-COVID-19 Syndrome
- Being tested
- 6-Week Self-Management Group
- Keywords
- Post-COVID-19, Self-management
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-Week Self-Management GroupBehavioural
The goal of the 6-session group-based intervention for patients with Post-COVID is to teach patients behavioral strategies known to be helpful in managing several common Post-COVID symptoms, including fatigue, memory and attention issues, poor sleep, breathlessness, coping with anxiety and uncertainty, and stress management. It is currently available to patients who are seen in the Post-COVID-19 Rehabilitation and Recovery Clinic at UW and the Post-COVID-19 Clinic in VAPSHCS Rehabilitation Care Services.
| Study group | Role | What they receive |
|---|---|---|
| 6-Week Self-Management Group | Active comparator | 6-week telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. The intervention consists of six weekly group sessions that are 1.5 hours long. Group size is 8-10 participants. Receives: Behavioral: 6-Week Self-Management Group |
| 6-Week Waitlist Group | No intervention | 6-week waitlist period during which participants will complete study assessments. After completing the study, waitlist participants will be offered the active intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.
Measured: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Appropriateness
Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.
Measured: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Feasibility
Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.
Measured: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Secondary outcomes (10)
Depressive Symptoms
Change in Mood will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of depressive symptoms.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Anxiety Symptoms
Change in Anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of anxiety.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Fatigue
Change in Fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of fatigue.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Sleep Disturbance
Change in Sleep Disturbance will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of sleep disturbance.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Perceived Cognitive Difficulties
Change in Perceived Cognitive Difficulties will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of perceived cognitive difficulties.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Self-Efficacy
Change in Self-Efficacy will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of self-efficacy.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Psychosocial Functioning
Change in Psychosocial Functioning will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of ability to participate in social roles and activities.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Pain Interference
Change in Pain Interference will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of pain interference.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Impression of Change
Impression of Change will be measured with the Patient Global Impression of Change scale. Higher scores on this one-item scale indicate higher self-reported levels of impression of change.
Measured: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Symptoms and Impact of Post-COVID
Symptoms and Impact of Post-COVID will be measured with the Long COVID Symptom and Impact Tools (ST and IT). When assessed via online survey, responses from the Long COVID Symptom Tool (ST) items will be scored as a simple count (yes/no). Higher scores indicate higher self-reported levels of symptoms of Post-COVID. Responses from the Long COVID Impact Tool (IT) will be summed. Higher scores indicate higher self-reported levels of impact of Post-COVID.
Measured: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start18 Jan 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, 2-group parallel design, 50-subject pilot clinical trial to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Herring, University of Washington
- Investigators
- Tracy Herring, PhD, Principal investigator, University of WashingtonLindsey Knowles, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658536
- Sponsor's protocol ID
- STUDY00016345
- Status last verified
- Mar 2024
- First submitted
- 16 Dec 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and send to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) the dataset (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.
Publications
Knowles LM, Grewal M, Drever SA, Hoffman JM, Friedly JL, Herring TE. A pilot randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol. Pilot Feasibility Stud. 2024 Jun 17;10(1):93. doi: 10.1186/s40814-024-01515-2.
PubMed 38886814
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID
- ClinicalTrials.gov ID
- NCT05658536
- Acronym / sponsor ID
- STUDY00016345
- Conditions
- Post COVID-19 Condition, Post-COVID-19 Syndrome
- Keywords
- Post-COVID-19, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Dec 2022 (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.
This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
Detailed description
Post-acute sequelae SARS-CoV-2 infection (PASC), also referred to as Post-COVID, is an emerging condition with debilitating symptoms relevant to rehabilitation medicine. Post-COVID has been described as the "next national health disaster". The Centers for Disease Control and Prevention describe Post COVID as a wide range of physical and mental health symptoms lasting four or more weeks after SARS-CoV-2 infection. Some of the most common and disabling symptoms include, fatigue, memory issues, pain-related symptoms, insomnia, and shortness of breath. In addition to these physical symptoms, many patients with Post-COVID report co-occurring mental health concerns, including anxiety and depression. It is believed that over 100 million people worldwide currently experience or have experienced Post COVID. Importantly, this condition can be debilitating and disabling - nearly one in five people reported not working as a direct result of Post COVID.
Psychosocial self-management interventions are a promising treatment for helping people with Post COVID manage their symptoms and engage in adaptive coping. Unfortunately, there is currently no cure for Post COVID, and it is unclear at what timepoint patients will recover or what proportion of patients will recover. Given the variability and chronicity of Post COVID symptoms, self-management interventions could be particularly beneficial. Research on patient populations with similar symptom profiles as Post COVID (e.g., myalgic encephalomyelitis, multiple sclerosis) suggests that psychosocial interventions like self-management can reduce symptom severity and interference and improve coping.
This randomized controlled pilot trial will use quantitative and qualitative methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
The study objectives include:
- To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID.
- To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping.
- To understand intervention participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of the Post-COVID intervention and their recommendations for improving the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, 2-group parallel design, 50-subject pilot clinical trial to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
| Arm | Type | Receives |
|---|---|---|
| 6-Week Self-Management Group | Active comparator | Behavioral: 6-Week Self-Management Group6-week telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. The intervention consists of six weekly group sessions that are 1.5 hours long. Group size is 8-10 participants. |
| 6-Week Waitlist Group | No intervention | –6-week waitlist period during which participants will complete study assessments. After completing the study, waitlist participants will be offered the active intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Resident of Washington state
- Diagnosis of a Post-COVID condition
- Able to read, speak, and understand English
- Availability of a telephone and internet access
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)
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 |
|---|---|---|
| 6-Week Self-Management GroupThe goal of the 6-session group-based intervention for patients with Post-COVID is to teach patients behavioral strategies known to be helpful in managing several common Post-COVID symptoms, including fatigue, memory and attention issues, poor sleep, breathlessness, coping with anxiety and uncertainty, and stress management. It is currently available to patients who are seen in the Post-COVID-19 Rehabilitation and Recovery Clinic at UW and the Post-COVID-19 Clinic in VAPSHCS Rehabilitation Care Services. | Behavioural | 6-Week Self-Management Group |
Primary outcome
Intervention Acceptability
Time frame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.
Intervention Appropriateness
Time frame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.
Intervention Feasibility
Time frame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items will be averaged to create an average score [1-5]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.
10 secondary outcomes
Depressive Symptoms
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Anxiety Symptoms
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Fatigue
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Sleep Disturbance
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Perceived Cognitive Difficulties
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Self-Efficacy
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Psychosocial Functioning
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Pain Interference
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
Impression of Change
Time frame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Symptoms and Impact of Post-COVID
Time frame: Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6)
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 29 Mar 2024.
- Derived from this study: PubMed 38886814Knowles LM, Grewal M, Drever SA, Hoffman JM, Friedly JL, Herring TE. A pilot randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol. Pilot Feasibility Stud. 2024 Jun 17;10(1):93. doi: 10.1186/s40814-024-01515-2.
- Individual participant dataSharing planned: Yes. We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and send to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) the dataset (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.
Related trials for Post COVID-19 Condition
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Long COVID Brain Fog: Cognitive Rehabilitation Trial
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Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
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ME/CFS Brain Fog: Cognitive Rehabilitation Trial
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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.
Tracy Herring, PhD principal investigator
University of Washington
Lindsey Knowles, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-Week Self-Management Group in people with Post COVID-19 Condition and Post-COVID-19 Syndrome, run by University of Washington 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 5 inclusion and 2 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 29 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Intervention Acceptability (time frame: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)). The study lists 3 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 NCT05658536, which also lists 1 linked publication.
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 29 Mar 2024.