Post-COVID-19 SyndromeNCT05967039
Assessment of Functional Capacity in Long-COVID
An observational study of Post-COVID-19 Syndrome and Long COVID, run by Centro Universitário Augusto Motta at 2 sites in Brazil.
Trial summary
A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Long COVID
- What is being tested?
- Physiotherapy
- How many people
- 65 participants
- Where
- 2 sitesBrazil
- Study dates
- 8 Aug 2022to 31 Dec 2023
- Phase
- Observational
- 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
Study population: Patients with long-COVID-19 syndrome
Who may be able to join
- Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU.
Who cannot join
- Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not associated with COVID-19.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Agnaldo José Lopes
Rio de Janeiro, 22745-271
Centro Universitario Augusto Motta
Rio de Janeiro, 22745271
About this study
Official title: Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy
A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.
Read the detailed description
Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease.
Objective: The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not.
Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).
It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.
- Conditions
- Post-COVID-19 Syndrome, Long COVID
- Being tested
- Physiotherapy
- Keywords
- Functional capacity;, Six-minute walk test;, Spirometry;, Oscillometry;, Lung Ultrasound;, Ventilometry;
- 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.
PhysiotherapyOther
Physiotherapy in respiratory rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Control | This is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy. Receives: Other: Physiotherapy | |
| Intervention | This is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test coupled into the measurement of pulmonary ventilation
The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity
Measured: October 2023
Secondary outcomes (4)
Impulse oscillometry
The IOS will be performed using an impulse oscillometer (Quark i2m, Cosmed, Rome Italy). During the IOS assessment, participants will be guided to stay seated, keeping the head in a neutral position, with manual support on the cheeks and with the nostrils occluded by a clip and then they will breathe usually for 40 seconds (ALBUQUERQUE et al., 2015). The values of acceptable minimum coherence will be ≥0.9 Hz. The following resistive and reactive parameters were evaluated: Rsr at 4 Hz (R4), 6 Hz (R6), 10 Hz (R10) and 20 Hz (R20); average resistance between 4-20 Hz (Rm); heterogeneity of resistance between R4 and R20 (R4-R20); resonant frequency (Fres); and area under reactance curve (AX). The values of R4, R6, R10 and R20 will be considered 34 abnormal when ≥150% of predicted (OOSTVEEN et al., 2013). A change in Fres and AX will be considered when >12 Hz and >3.60 cm H2O/L/s, respectively (BERGER et al., 2013).
Measured: October 2023
Spirometry
It is a procedure that allows the diagnosis of ventilatory disorders and is capable of measuring the patient's pulmonary function - evaluating the volume and velocity of the air blown. It is done with the aid of a device, the spirometer. The patient breathes into this device and internal sensors measure the amount of air and air movement in the lungs.
Measured: October 2023
Lung ultrasound
Participants will perform the LUS on Aplio XG equipment Aplio XG (Toshiba Medical Systems, Tokyo, Japan) coupled to a linear transducer 7.5-10 megahertz (MHz) multi-frequency transducer or a 3.5-5 MHz convex transducer in B. All USP evaluations will be performed by the authors who, although not whether they are radiologists, they are all employees of Policlínica Piquet Carneiro and have at least least 9 years of USP experience at the participant screening site. All USP assessments will be performed by 2 examiners and, when disagreement between them will be resolved through collective discussion. With participants in a seated position, the capture of USP signals will be done in 6 areas of each hemithorax as follows (SOUMMER et al., 2012): two anterior, two side and two back. In the evaluation of the pathological signs of USP, the investigators will search for B lines >2, coalescing B lines, and subpleural consolidations (MAFORT et al., 2021).
Measured: October 2023
Functional Status scale PCFS
The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19, being a self-administered questionnaire for the patient who will be informed: how much are you currently affected in your daily life by COVID 19? The patient will indicate in a classification from 0 to 4 their degree of functional status
Measured: October 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start8 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967039
- Sponsor's protocol ID
- 30135320.0.0000.5259
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmad FB, Cisewski JA, Minino A, Anderson RN. Provisional Mortality Data - United States, 2020. MMWR Morb Mortal Wkly Rep. 2021 Apr 9;70(14):519-522. doi: 10.15585/mmwr.mm7014e1.
PubMed 33830988Al-Ani F, Chehade S, Lazo-Langner A. Thrombosis risk associated with COVID-19 infection. A scoping review. Thromb Res. 2020 Aug;192:152-160. doi: 10.1016/j.thromres.2020.05.039. Epub 2020 May 27.
PubMed 32485418Albuquerque CG, Andrade FM, Rocha MA, Oliveira AF, Ladosky W, Victor EG, Rizzo JA. Determining respiratory system resistance and reactance by impulse oscillometry in obese individuals. J Bras Pneumol. 2015 Sep-Oct;41(5):422-6. doi: 10.1590/S1806-37132015000004517.
PubMed 26578133American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020 Apr;26(4):450-452. doi: 10.1038/s41591-020-0820-9. No abstract available.
PubMed 32284615Bahl P, Doolan C, de Silva C, Chughtai AA, Bourouiba L, MacIntyre CR. Airborne or Droplet Precautions for Health Workers Treating Coronavirus Disease 2019? J Infect Dis. 2022 May 4;225(9):1561-1568. doi: 10.1093/infdis/jiaa189.
PubMed 32301491Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May-Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25.
PubMed 32247212Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
PubMed 32475821Beraldo GL, Fonseca EKUN, Yokoo P, Matos MJR, Rosa MEE, Silva MMA, Chate RC, Shoji H, Ishikawa WY. Novel coronavirus pneumonia and acute pulmonary thromboembolism: casualty or causality? Einstein (Sao Paulo). 2020 Jun 3;18:eAI5750. doi: 10.31744/einstein_journal/2020AI5750. eCollection 2020. No abstract available.
PubMed 32520072Berger KI, Reibman J, Oppenheimer BW, Vlahos I, Harrison D, Goldring RM. Lessons from the World Trade Center disaster: airway disease presenting as restrictive dysfunction. Chest. 2013 Jul;144(1):249-257. doi: 10.1378/chest.12-1411.
PubMed 23392588Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758Biryukov J, Boydston JA, Dunning RA, Yeager JJ, Wood S, Ferris A, Miller D, Weaver W, Zeitouni NE, Freeburger D, Dabisch P, Wahl V, Hevey MC, Altamura LA. SARS-CoV-2 is rapidly inactivated at high temperature. Environ Chem Lett. 2021;19(2):1773-1777. doi: 10.1007/s10311-021-01187-x. Epub 2021 Feb 3.
PubMed 33551702Buonsenso D, Sali M, Pata D, De Rose C, Sanguinetti M, Valentini P, Delogu G. Children and COVID-19: Microbiological and immunological insights. Pediatr Pulmonol. 2020 Oct;55(10):2547-2555. doi: 10.1002/ppul.24978. Epub 2020 Jul 30.
PubMed 32710652Butzko RP, Sotolongo AM, Helmer DA, Klein-Adams JC, Osinubi OY, Berman AR, Ortiz-Pacheco R, Falvo MJ. Forced oscillation technique in veterans with preserved spirometry and chronic respiratory symptoms. Respir Physiol Neurobiol. 2019 Feb;260:8-16. doi: 10.1016/j.resp.2018.11.012. Epub 2018 Nov 30.
PubMed 30508589Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy
- ClinicalTrials.gov ID
- NCT05967039
- Acronym / sponsor ID
- 30135320.0.0000.5259
- Conditions
- Post-COVID-19 Syndrome, Long COVID
- Keywords
- Functional capacity;, Six-minute walk test;, Spirometry;, Oscillometry;, Lung Ultrasound;, Ventilometry;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Aug 2023 (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.
A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.
Detailed description
Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease.
Objective: The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not.
Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).
It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: PhysiotherapyThis is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy. |
| Intervention | – | Other: PhysiotherapyThis is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with long-COVID-19 syndrome
Key inclusion criteria (1 listed)
- Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU.
Key exclusion criteria (1 listed)
- Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not associated with 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 |
|---|---|---|
| PhysiotherapyPhysiotherapy in respiratory rehabilitation | Other | Control, Intervention |
Primary outcome
Six-minute walk test coupled into the measurement of pulmonary ventilation
Time frame: October 2023
The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity
4 secondary outcomes
Impulse oscillometry
Time frame: October 2023
Spirometry
Time frame: October 2023
Lung ultrasound
Time frame: October 2023
Functional Status scale PCFS
Time frame: October 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 33830988Ahmad FB, Cisewski JA, Minino A, Anderson RN. Provisional Mortality Data - United States, 2020. MMWR Morb Mortal Wkly Rep. 2021 Apr 9;70(14):519-522. doi: 10.15585/mmwr.mm7014e1.
- Background: PubMed 32485418Al-Ani F, Chehade S, Lazo-Langner A. Thrombosis risk associated with COVID-19 infection. A scoping review. Thromb Res. 2020 Aug;192:152-160. doi: 10.1016/j.thromres.2020.05.039. Epub 2020 May 27.
- Background: PubMed 26578133Albuquerque CG, Andrade FM, Rocha MA, Oliveira AF, Ladosky W, Victor EG, Rizzo JA. Determining respiratory system resistance and reactance by impulse oscillometry in obese individuals. J Bras Pneumol. 2015 Sep-Oct;41(5):422-6. doi: 10.1590/S1806-37132015000004517.
- Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
- Background: PubMed 32284615Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020 Apr;26(4):450-452. doi: 10.1038/s41591-020-0820-9. No abstract available.
- Background: PubMed 32301491Bahl P, Doolan C, de Silva C, Chughtai AA, Bourouiba L, MacIntyre CR. Airborne or Droplet Precautions for Health Workers Treating Coronavirus Disease 2019? J Infect Dis. 2022 May 4;225(9):1561-1568. doi: 10.1093/infdis/jiaa189.
- Background: PubMed 32247212Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May-Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25.
- Background: PubMed 32475821Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
- Background: PubMed 32520072Beraldo GL, Fonseca EKUN, Yokoo P, Matos MJR, Rosa MEE, Silva MMA, Chate RC, Shoji H, Ishikawa WY. Novel coronavirus pneumonia and acute pulmonary thromboembolism: casualty or causality? Einstein (Sao Paulo). 2020 Jun 3;18:eAI5750. doi: 10.31744/einstein_journal/2020AI5750. eCollection 2020. No abstract available.
- Background: PubMed 23392588Berger KI, Reibman J, Oppenheimer BW, Vlahos I, Harrison D, Goldring RM. Lessons from the World Trade Center disaster: airway disease presenting as restrictive dysfunction. Chest. 2013 Jul;144(1):249-257. doi: 10.1378/chest.12-1411.
- Background: PubMed 32227758Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
- Background: PubMed 33551702Biryukov J, Boydston JA, Dunning RA, Yeager JJ, Wood S, Ferris A, Miller D, Weaver W, Zeitouni NE, Freeburger D, Dabisch P, Wahl V, Hevey MC, Altamura LA. SARS-CoV-2 is rapidly inactivated at high temperature. Environ Chem Lett. 2021;19(2):1773-1777. doi: 10.1007/s10311-021-01187-x. Epub 2021 Feb 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID-19 Syndrome and Long COVID, run by Centro Universitário Augusto Motta at 2 sites in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
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?
Six-minute walk test coupled into the measurement of pulmonary ventilation (time frame: October 2023). 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 NCT05967039, which also lists 56 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 7 Aug 2023.