COVID-19Phase 2HOT-LoCONCT04842448
Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome
A Phase 2 study testing Hyperbaric oxygen in people with COVID-19 and Post COVID-19 Condition, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19, Post COVID-19 Condition, Post COVID-19 Condition, Unspecified
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2021to 17 Jun 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years
- Healthy or mild systemic disease (ASA 1-2) prior to COVID-19
- Symptoms consistent with Long COVID for at least 12 weeks
- Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
- Working or studying prior to COVID-19
- Documented informed consent according to GCP and national regulations
Who cannot join
- Known pregnancy or positive pregnancy test in women of childbearing age
- ASA 3 or more from other cause than Long COVID
- Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF)
- Diabetes
- Diagnosed with hypertension prior to COVID-19
- Contraindication for hyperbaric oxygen treatment according to local guidelines
- Participation or recent participation in a clinical trial with an investigational product
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial
Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and we are facing an emerging problem that will severely affect individuals, health care systems and society for years to come.
We explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial as a potential treatment for patients suffering from Long COVID.
The overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms associated with Long COVID.
Read the detailed description
Phase II Clinical Trial
Prospective randomized, placebo-controlled, double blind, phase II, clinical trial, estimated enrolment: 80 subjects Parallel groups Intervention: HBO2: 240 kPa for 90 min, maximum 10 treatments within 6 weeks from randomization
Control: Placebo treatment with 'sham' air breathing at a moderately higher pressure (134 kPa) to simulate hyperbaric chamber treatment, maximum 10 treatments within 6 weeks from randomization
The population will comprise of previously healthy patients (American Society of Anaesthesiologists (ASA) class 1-2 diagnosed with Long COVID (U09.9) by a multidisciplinary team. All patients are assessed with a battery of questionnaires, physical tests, laboratory tests and radiology. After their first assessment, individuals may have further organ specific work up for diagnosis, such as diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS).
Once the patient has been diagnosed with Long COVID, they will be informed and asked to participate in the trial. No study specific procedures will take place before an informed consent form (ICF) has been signed. The patients will be included once they fulfil the inclusion criteria and exhibit none of the exclusion criteria. Some study specific procedures will be performed before inclusion. Eligible subjects will be randomized within two weeks of the planned first treatment. Subjects will be randomized in a 1:1 allocation to HBO2 or placebo (sham treatment). Scheduling of the HBOT will depend on available resources but the first treatment should be given within two weeks after randomization, and a maximum ten treatments should be given within 6 weeks from randomization.
Clinical equipoise: The rationale for 1:1 randomization is that this is a new disease and that it will maximise the statistical power to detect a statistically significant efficacy between treatment groups.
Main efficacy and safety endpoints will be evaluated at three months but the trial will continue for one year after inclusion or until withdrawal. There will also be a four year post-trial follow up of health-economy.
The trial will be conducted in compliance with Good Clinical Practice (GCP), the Declaration of Helsinki and national regulatory requirements.
- Conditions
- COVID-19, Post COVID-19 Condition, Post COVID-19 Condition, Unspecified, Post COVID Condition, Post-COVID Syndrome, Post-Acute COVID-19 Syndrome
- Being tested
- Hyperbaric oxygen, Sham treatment
- Keywords
- Long COVID, Post COVID Syndrome, COVID-19, Hyperbaric Oxygen, HBOT, Health Related Quality of Life, Endothelial dysfunction
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Also called HBO, HBO2, HBOT
Hyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, 2 air bakes and 10 minutes decompression time).
Sham treatmentProcedure or surgery
Also called Placebo
Sham treatment 134-120 kPa Air (with 5 min compression time, and 5 min decompression to 120 kPa, two air brakes will be reported to the subjects)
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | HBO2 240 kPa, 90 min, maximum 10 treatments Receives: Drug: Hyperbaric oxygen |
| Sham treatment | Placebo comparator | Air 134-120 kPa, 90 min, maximum 10 treatments Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAND 36 change
Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF).
RAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
Measured: Baseline and 13 weeks
Secondary outcomes (5)
Endothelial dysfunction
Mean change from baseline to 13 weeks in Reactive Hyperemia Index (RHI)
Measured: Baseline and 13 weeks
6-min walk test
Mean change from baseline to 13 weeks in the 6-min walk test
Measured: Baseline and 13 weeks
30/60 min chair stand
Mean change from baseline to 13 weeks in the 30/60 sec chair stand
Measured: Baseline and 13 weeks
EQ-5D
Mean change from baseline to 13 weeks in EQ-5D.
EuroQol-5 Dimensions questionnaire is a widely used self-reporting questionnaire that measure 5 dimensions of health TODAY at three or five levels (EQ-5D-3L or EQ-5D-5L) of severity; no problems, some/moderate problems and extreme problems/unable.The health dimensions are mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS) 0-100 which it used as a quantitative measure of overall health status. EQ-5D is the most widely used questionnaire for health-economic evaluation.
Measured: Baseline and 13 weeks
RAND 36 normalization
Proportion of subjects with a normalisation of levels in RAND-36 domains role limitations due to physical health and physical functioning respectively, at 13 weeks.
Measured: Baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Sep 2021
- Primary completion27 Sep 2023
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Randomized, placebo-controlled, double-blind, phase II
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Karolinska Trial Alliance, EDC Scandinavia AB, Swedish Heart Lung Foundation, Region Stockholm, The Swedish Research Council
- Responsible party
- Principal investigator, Anders Kjellberg, MD, Karolinska University Hospital
- Investigators
- Anders Kjellberg, MD, PhD, Principal investigator, Karolinska University Hospital (and Karolinska Insitutet)Judith Bruchfeld, MD, PhD, Study chair, Karolinska University Hospital (and Karolinska Insitutet)Malin Nygren-Bonnier, PhD, Study chair, Karolinska University Hospital (and Karolinska Insitutet)Michael Runold, MD, PhD, Study chair, Karolinska University Hospital (and Karolinska Insitutet)Marcus Ståhlberg, MD, PhD, Study chair, Karolinska University Hospital (and Karolinska Insitutet)Peter Lindholm, MD, PhD, Study chair, Karolinska Insitutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842448
- Sponsor's protocol ID
- HOT-LoCO
- Other IDs
- 2021-000764-30, K 2021-1592, 4-621/2021, 2022-00834, RS 2022-0674
- Acronym
- HOT-LoCO
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol, statistical plan and consent form will be publicly available. Data will be available on patient level; data will be pseudonymized, the full dataset and statistical code will be available upon request.
Publications
Venkatesan P. NICE guideline on long COVID. Lancet Respir Med. 2021 Feb;9(2):129. doi: 10.1016/S2213-2600(21)00031-X. Epub 2021 Jan 13. No abstract available.
PubMed 33453162Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
PubMed 33243837Kjellberg A, De Maio A, Lindholm P. Can hyperbaric oxygen safely serve as an anti-inflammatory treatment for COVID-19? Med Hypotheses. 2020 Nov;144:110224. doi: 10.1016/j.mehy.2020.110224. Epub 2020 Aug 30.
PubMed 33254531Kjellberg A, Abdel-Halim L, Hassler A, El Gharbi S, Al-Ezerjawi S, Bostrom E, Sundberg CJ, Pernow J, Medson K, Kowalski JH, Rodriguez-Wallberg KA, Zheng X, Catrina S, Runold M, Stahlberg M, Bruchfeld J, Nygren-Bonnier M, Lindholm P. Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. BMJ Open. 2022 Nov 2;12(11):e061870. doi: 10.1136/bmjopen-2022-061870.
PubMed 36323462Kjellberg A, Hassler A, Bostrom E, El Gharbi S, Al-Ezerjawi S, Schening A, Fischer K, Kowalski JH, Rodriguez-Wallberg KA, Bruchfeld J, Stahlberg M, Nygren-Bonnier M, Runold M, Lindholm P. Ten sessions of hyperbaric oxygen versus sham treatment in patients with long covid (HOT-LoCO): a randomised, placebo-controlled, double-blind, phase II trial. BMJ Open. 2025 Apr 14;15(4):e094386. doi: 10.1136/bmjopen-2024-094386.
PubMed 40228859Kjellberg A, Hassler A, Bostrom E, El Gharbi S, Al-Ezerjawi S, Kowalski J, Rodriguez-Wallberg KA, Bruchfeld J, Stahlberg M, Nygren-Bonnier M, Runold M, Lindholm P. Hyperbaric oxygen therapy for long COVID (HOT-LoCO), an interim safety report from a randomised controlled trial. BMC Infect Dis. 2023 Jan 20;23(1):33. doi: 10.1186/s12879-023-08002-8.
PubMed 36670365
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04842448
- Acronym / sponsor ID
- HOT-LoCO / HOT-LoCO
- Conditions
- COVID-19, Post COVID-19 Condition, Post COVID-19 Condition, Unspecified, Post COVID Condition, Post-COVID Syndrome, Post-Acute COVID-19 Syndrome
- Keywords
- Long COVID, Post COVID Syndrome, COVID-19, Hyperbaric Oxygen, HBOT, Health Related Quality of Life, Endothelial dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Karolinska Trial Alliance, EDC Scandinavia AB, Swedish Heart Lung Foundation, Region Stockholm, The Swedish Research Council
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 13 Apr 2021 (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.
Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and we are facing an emerging problem that will severely affect individuals, health care systems and society for years to come.
We explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial as a potential treatment for patients suffering from Long COVID.
The overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms associated with Long COVID.
Detailed description
Phase II Clinical Trial
Prospective randomized, placebo-controlled, double blind, phase II, clinical trial, estimated enrolment: 80 subjects Parallel groups Intervention: HBO2: 240 kPa for 90 min, maximum 10 treatments within 6 weeks from randomization
Control: Placebo treatment with 'sham' air breathing at a moderately higher pressure (134 kPa) to simulate hyperbaric chamber treatment, maximum 10 treatments within 6 weeks from randomization
The population will comprise of previously healthy patients (American Society of Anaesthesiologists (ASA) class 1-2 diagnosed with Long COVID (U09.9) by a multidisciplinary team. All patients are assessed with a battery of questionnaires, physical tests, laboratory tests and radiology. After their first assessment, individuals may have further organ specific work up for diagnosis, such as diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS).
Once the patient has been diagnosed with Long COVID, they will be informed and asked to participate in the trial. No study specific procedures will take place before an informed consent form (ICF) has been signed. The patients will be included once they fulfil the inclusion criteria and exhibit none of the exclusion criteria. Some study specific procedures will be performed before inclusion. Eligible subjects will be randomized within two weeks of the planned first treatment. Subjects will be randomized in a 1:1 allocation to HBO2 or placebo (sham treatment). Scheduling of the HBOT will depend on available resources but the first treatment should be given within two weeks after randomization, and a maximum ten treatments should be given within 6 weeks from randomization.
Clinical equipoise: The rationale for 1:1 randomization is that this is a new disease and that it will maximise the statistical power to detect a statistically significant efficacy between treatment groups.
Main efficacy and safety endpoints will be evaluated at three months but the trial will continue for one year after inclusion or until withdrawal. There will also be a four year post-trial follow up of health-economy.
The trial will be conducted in compliance with Good Clinical Practice (GCP), the Declaration of Helsinki and national regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind, phase II
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | Drug: Hyperbaric oxygenHBO2 240 kPa, 90 min, maximum 10 treatments |
| Sham treatment | Placebo comparator | Procedure: Sham treatmentAir 134-120 kPa, 90 min, maximum 10 treatments |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-60 years
- Healthy or mild systemic disease (ASA 1-2) prior to COVID-19
- Symptoms consistent with Long COVID for at least 12 weeks
- Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
- Working or studying prior to COVID-19
Key exclusion criteria (8 listed)
- Known pregnancy or positive pregnancy test in women of childbearing age
- ASA 3 or more from other cause than Long COVID
- Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF)
- Diabetes
- Diagnosed with hypertension prior to COVID-19
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 |
|---|---|---|
| Hyperbaric oxygenAlso: HBO, HBO2, HBOTHyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, 2 air bakes and 10 minutes decompression time). | Drug | Hyperbaric oxygen treatment |
| Sham treatmentAlso: PlaceboSham treatment 134-120 kPa Air (with 5 min compression time, and 5 min decompression to 120 kPa, two air brakes will be reported to the subjects) | Procedure or surgery | Sham treatment |
Primary outcome
RAND 36 change
Time frame: Baseline and 13 weeks
Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF). RAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
5 secondary outcomes
Endothelial dysfunction
Time frame: Baseline and 13 weeks
6-min walk test
Time frame: Baseline and 13 weeks
30/60 min chair stand
Time frame: Baseline and 13 weeks
EQ-5D
Time frame: Baseline and 13 weeks
RAND 36 normalization
Time frame: Baseline and 13 weeks
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 22 Aug 2024.
- Background: PubMed 33453162Venkatesan P. NICE guideline on long COVID. Lancet Respir Med. 2021 Feb;9(2):129. doi: 10.1016/S2213-2600(21)00031-X. Epub 2021 Jan 13. No abstract available.
- Background: PubMed 33243837Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
- Background: PubMed 33254531Kjellberg A, De Maio A, Lindholm P. Can hyperbaric oxygen safely serve as an anti-inflammatory treatment for COVID-19? Med Hypotheses. 2020 Nov;144:110224. doi: 10.1016/j.mehy.2020.110224. Epub 2020 Aug 30.
- Background: PubMed 36323462Kjellberg A, Abdel-Halim L, Hassler A, El Gharbi S, Al-Ezerjawi S, Bostrom E, Sundberg CJ, Pernow J, Medson K, Kowalski JH, Rodriguez-Wallberg KA, Zheng X, Catrina S, Runold M, Stahlberg M, Bruchfeld J, Nygren-Bonnier M, Lindholm P. Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. BMJ Open. 2022 Nov 2;12(11):e061870. doi: 10.1136/bmjopen-2022-061870.
- Derived from this study: PubMed 40228859Kjellberg A, Hassler A, Bostrom E, El Gharbi S, Al-Ezerjawi S, Schening A, Fischer K, Kowalski JH, Rodriguez-Wallberg KA, Bruchfeld J, Stahlberg M, Nygren-Bonnier M, Runold M, Lindholm P. Ten sessions of hyperbaric oxygen versus sham treatment in patients with long covid (HOT-LoCO): a randomised, placebo-controlled, double-blind, phase II trial. BMJ Open. 2025 Apr 14;15(4):e094386. doi: 10.1136/bmjopen-2024-094386.
- Derived from this study: PubMed 36670365Kjellberg A, Hassler A, Bostrom E, El Gharbi S, Al-Ezerjawi S, Kowalski J, Rodriguez-Wallberg KA, Bruchfeld J, Stahlberg M, Nygren-Bonnier M, Runold M, Lindholm P. Hyperbaric oxygen therapy for long COVID (HOT-LoCO), an interim safety report from a randomised controlled trial. BMC Infect Dis. 2023 Jan 20;23(1):33. doi: 10.1186/s12879-023-08002-8.
- Research group Hyperbaric Medicine at Karolinska InstitutetLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The full study protocol, statistical plan and consent form will be publicly available. Data will be available on patient level; data will be pseudonymized, the full dataset and statistical code will be available upon request.
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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.
Anders Kjellberg, MD, PhD principal investigator
Karolinska University Hospital (and Karolinska Insitutet)
Judith Bruchfeld, MD, PhD study chair
Karolinska University Hospital (and Karolinska Insitutet)
Malin Nygren-Bonnier, PhD study chair
Karolinska University Hospital (and Karolinska Insitutet)
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 Hyperbaric oxygen in people with COVID-19 and Post COVID-19 Condition, run by Karolinska University Hospital at 1 site in Sweden.
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 6 inclusion and 8 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 Aug 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 Sweden. 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?
RAND 36 change (time frame: Baseline and 13 weeks). 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 NCT04842448, which also lists 6 linked publications.
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 Aug 2024.