Cardiovascular Risk FactorNCT04422418
Impact of Burnout on Cardiovascular and Immune Biomarkers in Healthcare Professionals - Covid-19 Pandemic in Abu Dhabi
An observational study of Cardiovascular Risk Factor and Burnout, run by Khalifa University for Science and Technology at 4 sites in United Arab Emirates.
Trial summary
The main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor, Burnout, Immune Deficiency
- How many people
- 200 participants
- Where
- 4 sitesUnited Arab Emirates
- Study dates
- 1 Jul 2020to 31 Dec 2020
- 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: Residents, staff physicians, nurses and auxiliary healthcare professionals (adult males and females over 18 years) from both inpatient and outpatient medicine services
Who may be able to join
- all residents, staff physicians, nurses and auxiliary healthcare professionals from both inpatient and outpatient medicine services who agreed to be a part of the study will be provided with heart rate tracking devices to monitor heart rate.
Who cannot join
- not willing to complete written consent form.
Trial locations and contacts
4 sites in 1 country.
United Arab Emirates4 sites, 4 recruiting
- Recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi
Wael Almahmeed, MD, MahmeeW@ClevelandClinicAbuDhabi.ae
Khurram Ali, MD
- Recruiting
Mediclinic
Abu Dhabi
Ahmad Mounir, MD, farah8feb@yahoo.co.uk
- Recruiting
Sheikh Khalifa Medical City
Abu Dhabi
Seema El Khider Nour, MD, snour@seha.ae
- Recruiting
Sheikh Shakhbout Medical City
Abu Dhabi
Nadya Matroushi, MD, nmatroshi@seha.ae
About this study
Official title: Multi-Center Prospective Cohort Study: Impact of Burnout on Cardiovascular and Immune Biomarkers Among Frontline Healthcare Professionals During Covid-19 Pandemic in Abu Dhabi Emirate
The main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic.
Read the detailed description
Introduction: The coronavirus disease 2019 (COVID-19) pandemic has created new and unpredictable challenges for healthcare systems. Healthcare professionals are heavily affected by this rapidly changing situation. They may experience psychological burden, especially nurses, women, and frontline health care professionals directly engaged in the diagnosis, treatment, and care for patients with COVID-19. The objective of this study is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare professionals with different levels of exposure to the COVID-19 pandemic. The effects of the pandemic work burden on psychological, cardiovascular and immune biomarkers will be stratified per level of exposure to the COVID-19 pandemic, positive diagnosis to COVID-19, profession, sex, age and already existent cardiovascular risk.
Methods: A STROBE compliant, blended exploratory study involving online and onsite approach with wearable monitoring will be implemented. A planned random probability sample of residents, staff physicians, nurses and auxiliary healthcare professionals will be recruited from both inpatient and outpatient medicine services will be stratified by exposure to COVID-19 pandemic (frontline versus second line). In a first step, will be an online recruitment with e-consent and e-survey with Maslach Burnout Inventory, Fuster-BEWAT score and sociodemographic characteristics, and planning for onsite visit; in a second step, will be a setup for wearable monitoring of heart rate, actimetry and sleep quality together with blood sampling for immune biomarkers; steps 1 \& 2 will be repeated at 2-3 months, 6 months. Power BI \& Tableau will be used for data visualization purposes, while the front-end data capture application will be used for data collection and will be built using specific survey/questionnaire related tools for healthcare usage data linkage.
Ethics and dissemination: Institutional Review Board approval has been obtained from Khalifa University (protocol # CPRA-2020-034) and Department of Health-Abu Dhabi (protocol # CVDC-20-05/2020-8). Data analysis, release of results and publication of manuscripts are scheduled to start in early 2021. Data and findings may be useful to healthcare policymakers for developing preventive strategies to reduce or prevent burnout, cardiovascular risk and immune dysfunction.
- Conditions
- Cardiovascular Risk Factor, Burnout, Immune Deficiency
- Keywords
- Pandemics, Healthcare professionals, Burnout, Cardiovascular risk
- Medical subject headings
- Burnout, Psychological, Immunologic Deficiency Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Burnout at 2-3 months and 6 months
Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
Measured: baseline, 2-3 months, 6 months
Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.
Measured: baseline, 2-3 months, 6 months
Change from Baseline Through Actigraphy at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.
Measured: baseline, 2-3 months, 6 months
Change from Baseline Through Sleep Quality at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.
Measured: baseline, 2-3 months, 6 months
Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months
Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).
Measured: baseline, 2-3 months, 6 months
Change from Baseline Immune Dysfunction at 2-3 months and 6 months
Classification of the immune function will be screened.
Measured: baseline, 2-3 months, 6 months
Secondary outcomes (1)
Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months
Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).
Measured: baseline, 2-3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020
- Primary completion14 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khalifa University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Zayed Military Hospital, Abu Dhabi University, Cleveland Clinic Abu Dhabi, Sheikh Khalifa Medical City, Sheikh Shakhbout Medical City, Mediclinic Middle East, Myriad Global Solutions
- Responsible party
- Sponsor
- Investigators
- Wael Almahmeed, MD, Study chair, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422418
- Sponsor's protocol ID
- CPRA-2020-034
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira VL Jr, Dobre M, Dos Santos SG, Fuzatti JS, Oliveira CR, Campos LA, Brateanu A, Baltatu OC. Association between Carotid Intima Media Thickness and Heart Rate Variability in Adults at Increased Cardiovascular Risk. Front Physiol. 2017 Apr 26;8:248. doi: 10.3389/fphys.2017.00248. eCollection 2017.
PubMed 28491040Pinheiro Ade O, Pereira VL Jr, Baltatu OC, Campos LA. Cardiac autonomic dysfunction in elderly women with myocardial infarction. Curr Med Res Opin. 2015;31(10):1849-54. doi: 10.1185/03007995.2015.1074065. Epub 2015 Aug 26.
PubMed 26196167da Silva ELP, Pereira R, Reis LN, Pereira VL Jr, Campos LA, Wessel N, Baltatu OC. Heart rate detrended fluctuation indexes as estimate of obstructive sleep apnea severity. Medicine (Baltimore). 2015 Jan;94(4):e516. doi: 10.1097/MD.0000000000000516.
PubMed 25634206Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9.
PubMed 26562047Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032.
PubMed 29145946Henriksen A, Grimsgaard S, Horsch A, Hartvigsen G, Hopstock L. Validity of the Polar M430 Activity Monitor in Free-Living Conditions: Validation Study. JMIR Form Res. 2019 Aug 16;3(3):e14438. doi: 10.2196/14438.
PubMed 31420958Alameri F, Aldaheri N, Almesmari S, Basaloum M, Albeshr NA, Simsekler MCE, Ugwuoke NV, Dalkilinc M, Al Qubaisi M, Campos LA, Almahmeed W, Alefishat E, Al Tunaiji H, Baltatu OC. Burnout and Cardiovascular Risk in Healthcare Professionals During the COVID-19 Pandemic. Front Psychiatry. 2022 Apr 4;13:867233. doi: 10.3389/fpsyt.2022.867233. eCollection 2022.
PubMed 35444572Al Tunaiji H, Al Qubaisi M, Dalkilinc M, Campos LA, Ugwuoke NV, Alefishat E, Aloum L, Ross R, Almahmeed W, Baltatu OC. Impact of COVID-19 Pandemic Burnout on Cardiovascular Risk in Healthcare Professionals Study Protocol: A Multicenter Exploratory Longitudinal Study. Front Med (Lausanne). 2020 Dec 22;7:571057. doi: 10.3389/fmed.2020.571057. eCollection 2020.
PubMed 33415114
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Prospective Cohort Study: Impact of Burnout on Cardiovascular and Immune Biomarkers Among Frontline Healthcare Professionals During Covid-19 Pandemic in Abu Dhabi Emirate
- ClinicalTrials.gov ID
- NCT04422418
- Acronym / sponsor ID
- CPRA-2020-034
- Conditions
- Cardiovascular Risk Factor, Burnout, Immune Deficiency
- Keywords
- Pandemics, Healthcare professionals, Burnout, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Khalifa University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Zayed Military Hospital, Abu Dhabi University, Cleveland Clinic Abu Dhabi, Sheikh Khalifa Medical City, Sheikh Shakhbout Medical City, Mediclinic Middle East, Myriad Global Solutions
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 14 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
The main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic.
Detailed description
Introduction: The coronavirus disease 2019 (COVID-19) pandemic has created new and unpredictable challenges for healthcare systems. Healthcare professionals are heavily affected by this rapidly changing situation. They may experience psychological burden, especially nurses, women, and frontline health care professionals directly engaged in the diagnosis, treatment, and care for patients with COVID-19. The objective of this study is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare professionals with different levels of exposure to the COVID-19 pandemic. The effects of the pandemic work burden on psychological, cardiovascular and immune biomarkers will be stratified per level of exposure to the COVID-19 pandemic, positive diagnosis to COVID-19, profession, sex, age and already existent cardiovascular risk.
Methods: A STROBE compliant, blended exploratory study involving online and onsite approach with wearable monitoring will be implemented. A planned random probability sample of residents, staff physicians, nurses and auxiliary healthcare professionals will be recruited from both inpatient and outpatient medicine services will be stratified by exposure to COVID-19 pandemic (frontline versus second line). In a first step, will be an online recruitment with e-consent and e-survey with Maslach Burnout Inventory, Fuster-BEWAT score and sociodemographic characteristics, and planning for onsite visit; in a second step, will be a setup for wearable monitoring of heart rate, actimetry and sleep quality together with blood sampling for immune biomarkers; steps 1 \& 2 will be repeated at 2-3 months, 6 months. Power BI \& Tableau will be used for data visualization purposes, while the front-end data capture application will be used for data collection and will be built using specific survey/questionnaire related tools for healthcare usage data linkage.
Ethics and dissemination: Institutional Review Board approval has been obtained from Khalifa University (protocol # CPRA-2020-034) and Department of Health-Abu Dhabi (protocol # CVDC-20-05/2020-8). Data analysis, release of results and publication of manuscripts are scheduled to start in early 2021. Data and findings may be useful to healthcare policymakers for developing preventive strategies to reduce or prevent burnout, cardiovascular risk and immune dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents, staff physicians, nurses and auxiliary healthcare professionals (adult males and females over 18 years) from both inpatient and outpatient medicine services
Key inclusion criteria (1 listed)
- all residents, staff physicians, nurses and auxiliary healthcare professionals from both inpatient and outpatient medicine services who agreed to be a part of the study will be provided with heart rate tracking devices to monitor heart rate.
Key exclusion criteria (1 listed)
- not willing to complete written consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline Burnout at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.
Change from Baseline Through Actigraphy at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.
Change from Baseline Through Sleep Quality at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.
Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).
Change from Baseline Immune Dysfunction at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Classification of the immune function will be screened.
1 secondary outcome
Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months
Time frame: baseline, 2-3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 28491040Pereira VL Jr, Dobre M, Dos Santos SG, Fuzatti JS, Oliveira CR, Campos LA, Brateanu A, Baltatu OC. Association between Carotid Intima Media Thickness and Heart Rate Variability in Adults at Increased Cardiovascular Risk. Front Physiol. 2017 Apr 26;8:248. doi: 10.3389/fphys.2017.00248. eCollection 2017.
- Background: PubMed 26196167Pinheiro Ade O, Pereira VL Jr, Baltatu OC, Campos LA. Cardiac autonomic dysfunction in elderly women with myocardial infarction. Curr Med Res Opin. 2015;31(10):1849-54. doi: 10.1185/03007995.2015.1074065. Epub 2015 Aug 26.
- Background: PubMed 25634206da Silva ELP, Pereira R, Reis LN, Pereira VL Jr, Campos LA, Wessel N, Baltatu OC. Heart rate detrended fluctuation indexes as estimate of obstructive sleep apnea severity. Medicine (Baltimore). 2015 Jan;94(4):e516. doi: 10.1097/MD.0000000000000516.
- Background: PubMed 26562047Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9.
- Background: PubMed 29145946Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032.
- Background: PubMed 31420958Henriksen A, Grimsgaard S, Horsch A, Hartvigsen G, Hopstock L. Validity of the Polar M430 Activity Monitor in Free-Living Conditions: Validation Study. JMIR Form Res. 2019 Aug 16;3(3):e14438. doi: 10.2196/14438.
- Derived from this study: PubMed 35444572Alameri F, Aldaheri N, Almesmari S, Basaloum M, Albeshr NA, Simsekler MCE, Ugwuoke NV, Dalkilinc M, Al Qubaisi M, Campos LA, Almahmeed W, Alefishat E, Al Tunaiji H, Baltatu OC. Burnout and Cardiovascular Risk in Healthcare Professionals During the COVID-19 Pandemic. Front Psychiatry. 2022 Apr 4;13:867233. doi: 10.3389/fpsyt.2022.867233. eCollection 2022.
- Derived from this study: PubMed 33415114Al Tunaiji H, Al Qubaisi M, Dalkilinc M, Campos LA, Ugwuoke NV, Alefishat E, Aloum L, Ross R, Almahmeed W, Baltatu OC. Impact of COVID-19 Pandemic Burnout on Cardiovascular Risk in Healthcare Professionals Study Protocol: A Multicenter Exploratory Longitudinal Study. Front Med (Lausanne). 2020 Dec 22;7:571057. doi: 10.3389/fmed.2020.571057. eCollection 2020.
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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.
Wael Almahmeed, MD study chair
Cleveland Clinic Abu Dhabi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Burnout, run by Khalifa University for Science and Technology at 4 sites in United Arab Emirates.
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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Arab Emirates. 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?
Contact Ovidiu C Baltatu, MD PhD (+971 2 810 9797, ovidiu.baltatu@ku.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Burnout at 2-3 months and 6 months (time frame: baseline, 2-3 months, 6 months). The study lists 6 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 NCT04422418, which also lists 8 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 3 Nov 2020.