COVID-19FUNCTIONNCT05386485
Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From COVID-19.
An observational study of COVID-19, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- None intervation
- How many people
- 162 participants
- Where
- 1 sitePeru
- Study dates
- 7 Aug 2021to Oct 2022
- 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: Inpatients will be screened and recruited mainly from Cayetano Heredia Hospital, a tertiary-level referral center with an assigned population of nearly 3 million individuals. Also patients admitted into different public or private institutions in Lima could be considered. Outpatients will be screened and recruited from primary level health care centers located in different parts of Lima.
Who may be able to join
- Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:
- Individuals of any sex over 18 years of age
- A positive COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques within the last 14 days prior the enrollment. A laboratory-based confirmatory report will be required
- Recruitment time close around the discharge date or no longer than 7 days after discharge
- Group A: Individuals who had not reported signs or symptoms suggestive of COVID-19 infection
- Group B: Individuals who had reported signs or symptoms suggestive of COVID-19 infection
Who cannot join
- An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:
- A negative COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques
- Known inability to keep adherent to the study (ex. incarceration, migration, travel)
- Active pregnancy confirmed by either qualitative urine or quantitative blood beta-hCG test
Trial locations and contacts
1 site in 1 country.
Peru1 site
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia
Lima Lima, Lima
About this study
Official title: FUNCTION Study: Follow- Up Study iN SARS-CoV-2 infecTION. Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From SARS-CoV-2 Infection in Lima, Peru
FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital.
The overall aim is to asses the long-term impact of SARS-CoV-2 infection on the cardiopulmonary function and quality of life in patients recovered from COVID-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.
- Conditions
- COVID-19
- Being tested
- None intervation
- Keywords
- COVID-19, SARS-Cov-2, Cardiovascular function, Respiratory function, Life quality, Long COVID, COVID19 Sequelae, Function test
- Medical subject headings
- COVID-19, Respiratory Aspiration, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None intervationOther
Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Group A (asymptomatic infection) | Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge. Receives: Other: None intervation | |
| Group B1 (mild symptomatic infection) | Clinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and no radiological evidence of pneumonia Receives: Other: None intervation | |
| Group B2 (moderate symptomatic infection) | Clinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and radiological evidence of pneumonia Receives: Other: None intervation | |
| Group B3 (severe symptomatic infection) | Clinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and radiological evidence of pneumonia Receives: Other: None intervation | |
| Group B4 (critical symptomatic infection) | Clinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and at least one of the following:
I) Acute Respiratory Distress Syndrome: defined under Berlin Criteria mostly defined by a PaFi<200, II) Shock: Patient diagnosed with sepsis that despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure ≥65 mmHg and lactate values >2 mmol/L (>18 mg/dL) or III) Organ dysfunction that requires ICU admission Receives: Other: None intervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal pulmonary function
% of participants with carbon monoxide diffusing capacity lower than 80 percent of predicted at each study visit. The dependent variable will be categorized as dichotomic variable for subsequent analysis
Measured: 6 months
Abnormal cardiovascular function
LVEF<50% will be considered an abnormal cardiovascular function test. The dependent variable will be categorized as dichomotoic variables for subsequent analysis.
Measured: 6 months
Abnormal quality of life
Health-related quality of life, Medical Outcomes Study short-form (SF-36) at each visit assessed using the Short Form-36 (SF-36). The SF-36 scale consists of 8 dimensions which is subsequently converted into a percentage score. The dependent variable will be categorized as dichotomic variable for subsequent analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start7 Aug 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo A Cachay, MD, Principal investigator, Universidad Peruana Cayetano HerediaEduardo Gotuzzo, MD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386485
- Sponsor's protocol ID
- SIDISI 203725
- Other IDs
- IN-US-983-6130
- Acronym
- FUNCTION
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
PubMed 33892403Venkataraman T, Frieman MB. The role of epidermal growth factor receptor (EGFR) signaling in SARS coronavirus-induced pulmonary fibrosis. Antiviral Res. 2017 Jul;143:142-150. doi: 10.1016/j.antiviral.2017.03.022. Epub 2017 Apr 5.
PubMed 28390872Yao XH, Li TY, He ZC, Ping YF, Liu HW, Yu SC, Mou HM, Wang LH, Zhang HR, Fu WJ, Luo T, Liu F, Guo QN, Chen C, Xiao HL, Guo HT, Lin S, Xiang DF, Shi Y, Pan GQ, Li QR, Huang X, Cui Y, Liu XZ, Tang W, Pan PF, Huang XQ, Ding YQ, Bian XW. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi. 2020 May 8;49(5):411-417. doi: 10.3760/cma.j.cn112151-20200312-00193. Chinese.
PubMed 32172546Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25.
PubMed 33262076Siddiqi HK, Libby P, Ridker PM. COVID-19 - A vascular disease. Trends Cardiovasc Med. 2021 Jan;31(1):1-5. doi: 10.1016/j.tcm.2020.10.005. Epub 2020 Oct 14.
PubMed 33068723Di Toro A, Bozzani A, Tavazzi G, Urtis M, Giuliani L, Pizzoccheri R, Aliberti F, Fergnani V, Arbustini E. Long COVID: long-term effects? Eur Heart J Suppl. 2021 Oct 8;23(Suppl E):E1-E5. doi: 10.1093/eurheartj/suab080. eCollection 2021 Oct.
PubMed 34650349Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022 Mar;28(3):583-590. doi: 10.1038/s41591-022-01689-3. Epub 2022 Feb 7.
PubMed 35132265Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
PubMed 33273026Taboada M, Moreno E, Carinena A, Rey T, Pita-Romero R, Leal S, Sanduende Y, Rodriguez A, Nieto C, Vilas E, Ochoa M, Cid M, Seoane-Pillado T. Quality of life, functional status, and persistent symptoms after intensive care of COVID-19 patients. Br J Anaesth. 2021 Mar;126(3):e110-e113. doi: 10.1016/j.bja.2020.12.007. Epub 2020 Dec 10. No abstract available.
PubMed 33413976Daugherty SE, Guo Y, Heath K, Dasmarinas MC, Jubilo KG, Samranvedhya J, Lipsitch M, Cohen K. Risk of clinical sequelae after the acute phase of SARS-CoV-2 infection: retrospective cohort study. BMJ. 2021 May 19;373:n1098. doi: 10.1136/bmj.n1098.
PubMed 34011492Cachay R, Watanabe-Tejada T, Cuno K, Gil-Zacarias M, Coombes C, Ballena I, Mejia F, Medina F, Gayoso O, Seas C, Otero L, Gotuzzo E. Long-term impact on cardiopulmonary function and quality of life among patients recovered from SARS-CoV-2 infection in a 6-month follow-up period in Lima, Peru: FUNCTION cohort study protocol. BMJ Open. 2023 Apr 20;13(4):e067365. doi: 10.1136/bmjopen-2022-067365.
PubMed 37080629
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUNCTION Study: Follow- Up Study iN SARS-CoV-2 infecTION. Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From SARS-CoV-2 Infection in Lima, Peru
- ClinicalTrials.gov ID
- NCT05386485
- Acronym / sponsor ID
- FUNCTION / SIDISI 203725
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-Cov-2, Cardiovascular function, Respiratory function, Life quality, Long COVID, COVID19 Sequelae, Function test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 May 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.
FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital.
The overall aim is to asses the long-term impact of SARS-CoV-2 infection on the cardiopulmonary function and quality of life in patients recovered from COVID-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A (asymptomatic infection) | – | Other: None intervationAbsence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge. |
| Group B1 (mild symptomatic infection) | – | Other: None intervationClinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and no radiological evidence of pneumonia |
| Group B2 (moderate symptomatic infection) | – | Other: None intervationClinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and radiological evidence of pneumonia |
| Group B3 (severe symptomatic infection) | – | Other: None intervationClinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and radiological evidence of pneumonia |
| Group B4 (critical symptomatic infection) | – | Other: None intervationClinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and at least one of the following: I) Acute Respiratory Distress Syndrome: defined under Berlin Criteria mostly defined by a PaFi<200, II) Shock: Patient diagnosed with sepsis that despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure ≥65 mmHg and lactate values >2 mmol/L (>18 mg/dL) or III) Organ dysfunction that requires ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients will be screened and recruited mainly from Cayetano Heredia Hospital, a tertiary-level referral center with an assigned population of nearly 3 million individuals. Also patients admitted into different public or private institutions in Lima could be considered. Outpatients will be screened and recruited from primary level health care centers located in different parts of Lima.
Key inclusion criteria (6 listed)
- Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:
Key exclusion criteria (4 listed)
- An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:
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 |
|---|---|---|
| None intervationObservational Study | Other | Group A (asymptomatic infection), Group B1 (mild symptomatic infection), Group B2 (moderate symptomatic infection), Group B3 (severe symptomatic infection), Group B4 (critical symptomatic infection) |
Primary outcome
Abnormal pulmonary function
Time frame: 6 months
% of participants with carbon monoxide diffusing capacity lower than 80 percent of predicted at each study visit. The dependent variable will be categorized as dichotomic variable for subsequent analysis
Abnormal cardiovascular function
Time frame: 6 months
LVEF<50% will be considered an abnormal cardiovascular function test. The dependent variable will be categorized as dichomotoic variables for subsequent analysis.
Abnormal quality of life
Time frame: 6 months
Health-related quality of life, Medical Outcomes Study short-form (SF-36) at each visit assessed using the Short Form-36 (SF-36). The SF-36 scale consists of 8 dimensions which is subsequently converted into a percentage score. The dependent variable will be categorized as dichotomic variable for subsequent analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 33892403Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
- Background: PubMed 28390872Venkataraman T, Frieman MB. The role of epidermal growth factor receptor (EGFR) signaling in SARS coronavirus-induced pulmonary fibrosis. Antiviral Res. 2017 Jul;143:142-150. doi: 10.1016/j.antiviral.2017.03.022. Epub 2017 Apr 5.
- Background: PubMed 32172546Yao XH, Li TY, He ZC, Ping YF, Liu HW, Yu SC, Mou HM, Wang LH, Zhang HR, Fu WJ, Luo T, Liu F, Guo QN, Chen C, Xiao HL, Guo HT, Lin S, Xiang DF, Shi Y, Pan GQ, Li QR, Huang X, Cui Y, Liu XZ, Tang W, Pan PF, Huang XQ, Ding YQ, Bian XW. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi. 2020 May 8;49(5):411-417. doi: 10.3760/cma.j.cn112151-20200312-00193. Chinese.
- Background: PubMed 33262076Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25.
- Background: PubMed 33068723Siddiqi HK, Libby P, Ridker PM. COVID-19 - A vascular disease. Trends Cardiovasc Med. 2021 Jan;31(1):1-5. doi: 10.1016/j.tcm.2020.10.005. Epub 2020 Oct 14.
- Background: PubMed 34650349Di Toro A, Bozzani A, Tavazzi G, Urtis M, Giuliani L, Pizzoccheri R, Aliberti F, Fergnani V, Arbustini E. Long COVID: long-term effects? Eur Heart J Suppl. 2021 Oct 8;23(Suppl E):E1-E5. doi: 10.1093/eurheartj/suab080. eCollection 2021 Oct.
- Background: PubMed 35132265Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022 Mar;28(3):583-590. doi: 10.1038/s41591-022-01689-3. Epub 2022 Feb 7.
- Background: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background: PubMed 33273026Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
- Background: PubMed 33413976Taboada M, Moreno E, Carinena A, Rey T, Pita-Romero R, Leal S, Sanduende Y, Rodriguez A, Nieto C, Vilas E, Ochoa M, Cid M, Seoane-Pillado T. Quality of life, functional status, and persistent symptoms after intensive care of COVID-19 patients. Br J Anaesth. 2021 Mar;126(3):e110-e113. doi: 10.1016/j.bja.2020.12.007. Epub 2020 Dec 10. No abstract available.
- Background: PubMed 34011492Daugherty SE, Guo Y, Heath K, Dasmarinas MC, Jubilo KG, Samranvedhya J, Lipsitch M, Cohen K. Risk of clinical sequelae after the acute phase of SARS-CoV-2 infection: retrospective cohort study. BMJ. 2021 May 19;373:n1098. doi: 10.1136/bmj.n1098.
- Derived from this study: PubMed 37080629Cachay R, Watanabe-Tejada T, Cuno K, Gil-Zacarias M, Coombes C, Ballena I, Mejia F, Medina F, Gayoso O, Seas C, Otero L, Gotuzzo E. Long-term impact on cardiopulmonary function and quality of life among patients recovered from SARS-CoV-2 infection in a 6-month follow-up period in Lima, Peru: FUNCTION cohort study protocol. BMJ Open. 2023 Apr 20;13(4):e067365. doi: 10.1136/bmjopen-2022-067365.
- Pericarditis and myocarditis long after SARS-CoV-2 infection: a cross-sectional descriptive study in health-care workers. Eiros R, et al.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rodrigo A Cachay, MD principal investigator
Universidad Peruana Cayetano Heredia
Eduardo Gotuzzo, MD principal investigator
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 4 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 30 Aug 2022. 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 Peru. 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?
Abnormal pulmonary function (time frame: 6 months). 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 NCT05386485, which also lists 12 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 30 Aug 2022.