COVID-19COVID-19 EndoNCT04342637
COVID-19 Endoscopy Survey
An observational study of COVID-19, run by Al-Azhar University at 4 sites in 3 countries.
Trial summary
A questionnaire containing some critical questions about practice inside GI endoscopy units in different countries will be distributed via emails. Responses will be collected in an online platform and data will be analyzed to reveal the effect of SARS-CoV-2 pandemic on different aspects of GI endoscopy practice in the… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Practice details
- How many people
- 163 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Apr 2020to 1 May 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - physicians working and practicing in gastrointestinal endoscopy units worldwide
Who may be able to join
- physicians working in endoscopy units worldwide
Who cannot join
- physicians not working in endoscopy units worldwide
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Egypt2 sites
Al-Azhar Univerisity
Cairo, 11651
Faculty of Medicine, Zagazig University
Zagazig, Sharqia Province, 44519
United States1 site
Kings County Hospital Center, Brooklyn, NY, USA
Albertson, New York, 11507
About this study
Official title: Gastrointestinal Endoscopy in the Era of COVID-19: a Multinational Survey
A questionnaire containing some critical questions about practice inside GI endoscopy units in different countries will be distributed via emails. Responses will be collected in an online platform and data will be analyzed to reveal the effect of SARS-CoV-2 pandemic on different aspects of GI endoscopy practice in the studied countries.
Read the detailed description
Participants has to answer the following questions:
- Participating center data:
- Participant name (surname, first name): (optional)
- Participant email: (optional)
- Country: ……..
- Working days (before COVID-19): ……..
- Types of procedure performed /day (before COVID-19): …….
- Number of endoscopists /day (before COVID-19): …….
- Number of nursing staff /day (before COVID-19): …….
- Number of administrative staff /day (before COVID-19): …….
- Number of patients undergoing endoscopy/ day (before COVID-19): …….
- Availability of negative pressure rooms (before COVID-19): …….
- Number of endoscopy referrals/ day (before COVID-19): ……..
- Response to COVID-19:
- Working days (after COVID-19): ……..
- Types of procedure performed /day (after COVID-19): ……..
- Number of endoscopists /day (after COVID-19): ……..
- Number of nursing staff /day (after COVID-19): ……..
- Number of administrative staff /day (after COVID-19): ……..
- Do you consider teams (MD, RN, tech, anesthesia) that remain together for the entire day so as to compartmentalize and minimize personnel exposure?
- Number of patients undergoing endoscopy/ day (after COVID-19): ……..
- Number of endoscopy referrals/ day (after COVID-19): ……..
- Availability of negative pressure rooms or use portable industrial-grade high-efficiency particulate air (HEPA) filters as a reasonable alternative: ……..
- Which recommendations do you follow? WEO, AGA, BSG, APSDE, other
- Applying triage for patients: e.g. FTOCC (APSDE); dose this include any tests
- Do you use any of this for triage of patients: i) a telephone consultation with the referring provider or (ii) a telehealth visit with the patient or (iii) a multidisciplinary team approach or (virtual) disease/tumor board to facilitate decision-making for complicated patients.
- Prioritization:
Which classification do you use for endoscopic procedures?
- urgent, semi-urgent and elective during COVID-19 outbreak
- Time sensitive procedure:
- Time-sensitive procedures defined as procedures that if deferred may negatively impact patient-important outcomes. The decision to defer a procedure should be made on a case-by-case basis:
- Time-Sensitive* (within 24 hours-8 weeks):
- Threat to the patient's life or Permanent dysfunction of an organ e.g. diagnosis and treatment of GI bleeding or cholangitis
- Risk of metastasis or progression of stage of disease e.g. e.g. work up of symptoms suggestive of cancer
- Risk of rapidly worsening progression of disease or severity of symptoms e.g. management decisions, such as treatment for IBD
- Non-Time Sensitive: No short-term impact on patient-important outcomes e.g. screening or surveillance colonoscopy, follow up colonoscopy for +FIT
- What are the most common clinical presentations? (please choose all that apply): Upper GI bleeding, lower GI bleeding, cholangitis, suspected cancer, foreign body, relive of GI obstruction, gastrostomy, other
- Endoscopy and use of PPE:
- Did you receive appropriate education and training on infection control measures, including hand hygiene.
- Did you receive adequate training on gowning and removal of PPE?
- Do you practice Standard hand hygiene procedures before and after each case?
- What type of personal protective equipment (PPE) do you usually use for doing an endoscopic procedure nowadays? (choose all that apply) Surgical mask N95 mask Isolation gown with water resistance Head cover Eye protection Face shield N95 protection in combination with face shield or surgical mask Other (please specify): ……..
- Do you extend (over 8 hours) use of N95 masks?
- Do you re-use of N95 masks?
- Do you extend use (over 8 hours) any other equipment? : …..
- Do you re use any other equipment? …..
- If yes, please specify: …… If yes please specify: …..
- Do you use of double gloves? ……
- What PPE do you use for the following cases (choose all that apply)?
- Suspected cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- Probable cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- confirmed cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- Post endoscopy:
- Do you motion in your report the status of the patients (suspected, probable, confirmed case of SARS-CoV-2 infection?
- Do you use standard endoscopic decontamination or anything extra?
- Do you give time for sterilizing endoscopy room after each suspected or confirmed case of SARS-CoV-2 infection? How long?
- Do you call back your patients 2 weeks after procedure to ask them about symptoms/ diagnosis of SARS-CoV-2 infection?
- Did you report any endoscopy related SARS-CoV-2 infection in your center (anytime for HCWs \& up to two weeks after procedures for patients)?
- Are you preparing a management plan for the waiting list after the current phase of the pandemic?
- Conditions
- COVID-19
- Being tested
- Practice details
- Keywords
- Endoscopy, Gastrointestinal, COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice detailsOther
Physicians will report details of their endoscopy practice through answering the questions of the questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Practicing gastroenterologists | Practicing physicians performing gastrointestinal endoscpy Receives: Other: Practice details |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of GI societies recommendations on prevention of SARS-CoV-2 infection
To evaluate the validity of different GI societies recommendations applied locally and how effective they are in preventing transmission in endoscopy units through reporting any new cases developing COVID-19 within two weeks of doing endoscopy (whether a patient or health-care worker)
Measured: 4- 6 months
To measure the percentage change in performed endoscopic procedure in response to COVID-19
To measure the percentage change in performed endoscopic procedure in response to COVID-19 in different centers of the world and the alternative solutions given to overcome this problem.
Measured: 4- 6 months
Secondary outcomes (6)
Effect of COVID-19 precautions on procedure time
Effect of COVID-19 precautions on procedure time
Measured: 4- 6 months
Effect of COVID-19 precautions on time of disinfection
Effect of COVID-19 precautions on prolongatIon of time of disinfection
Measured: 4- 6 months
Effect of COVID-19 precautions on procedure success
Effect of COVID-19 precautions on the ability of the endoscopist to finish the procedure successfully
Measured: 4- 6 months
Effect of COVID-19 precautions on complications
Effect of COVID-19 precautions on occurrence of complications
Measured: 4- 6 months
Effect of COVID-19 precautions on working time
Effect of COVID-19 precautions on change of working time (prolongation or shortening)
Measured: 4- 6 months
Effect of COVID-19 precautions on staff number
Effect of COVID-19 precautions on change of staff number
Measured: 4- 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start10 Apr 2020
- Primary completion25 Apr 2020
- Study completion1 May 2020
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 Al-Azhar UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alboraie, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342637
- Sponsor's protocol ID
- WES-2
- Acronym
- COVID-19 Endo
- Status last verified
- May 2020
- First submitted
- 7 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication we may share data
Publications
Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.
PubMed 21435708Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
PubMed 32081636Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
PubMed 32178769Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, Falck-Ytter Y, El-Serag HB; AGA Institute. Electronic address: ewilson@gastro.org. AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic. Gastroenterology. 2020 Aug;159(2):739-758.e4. doi: 10.1053/j.gastro.2020.03.072. Epub 2020 Apr 1. No abstract available.
PubMed 32247018Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020 Jun;69(6):991-996. doi: 10.1136/gutjnl-2020-321185. Epub 2020 Apr 2.
PubMed 32241897
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Endoscopy in the Era of COVID-19: a Multinational Survey
- ClinicalTrials.gov ID
- NCT04342637
- Acronym / sponsor ID
- COVID-19 Endo / WES-2
- Conditions
- COVID-19
- Keywords
- Endoscopy, Gastrointestinal, COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 13 Apr 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.
A questionnaire containing some critical questions about practice inside GI endoscopy units in different countries will be distributed via emails. Responses will be collected in an online platform and data will be analyzed to reveal the effect of SARS-CoV-2 pandemic on different aspects of GI endoscopy practice in the studied countries.
Detailed description
Participants has to answer the following questions:
- Participating center data:
- Participant name (surname, first name): (optional)
- Participant email: (optional)
- Country: ……..
- Working days (before COVID-19): ……..
- Types of procedure performed /day (before COVID-19): …….
- Number of endoscopists /day (before COVID-19): …….
- Number of nursing staff /day (before COVID-19): …….
- Number of administrative staff /day (before COVID-19): …….
- Number of patients undergoing endoscopy/ day (before COVID-19): …….
- Availability of negative pressure rooms (before COVID-19): …….
- Number of endoscopy referrals/ day (before COVID-19): ……..
- Response to COVID-19:
- Working days (after COVID-19): ……..
- Types of procedure performed /day (after COVID-19): ……..
- Number of endoscopists /day (after COVID-19): ……..
- Number of nursing staff /day (after COVID-19): ……..
- Number of administrative staff /day (after COVID-19): ……..
- Do you consider teams (MD, RN, tech, anesthesia) that remain together for the entire day so as to compartmentalize and minimize personnel exposure?
- Number of patients undergoing endoscopy/ day (after COVID-19): ……..
- Number of endoscopy referrals/ day (after COVID-19): ……..
- Availability of negative pressure rooms or use portable industrial-grade high-efficiency particulate air (HEPA) filters as a reasonable alternative: ……..
- Which recommendations do you follow? WEO, AGA, BSG, APSDE, other
- Applying triage for patients: e.g. FTOCC (APSDE); dose this include any tests
- Do you use any of this for triage of patients: i) a telephone consultation with the referring provider or (ii) a telehealth visit with the patient or (iii) a multidisciplinary team approach or (virtual) disease/tumor board to facilitate decision-making for complicated patients.
- Prioritization:
Which classification do you use for endoscopic procedures?
- urgent, semi-urgent and elective during COVID-19 outbreak
- Time sensitive procedure:
- Time-sensitive procedures defined as procedures that if deferred may negatively impact patient-important outcomes. The decision to defer a procedure should be made on a case-by-case basis:
- Time-Sensitive* (within 24 hours-8 weeks):
- Threat to the patient's life or Permanent dysfunction of an organ e.g. diagnosis and treatment of GI bleeding or cholangitis
- Risk of metastasis or progression of stage of disease e.g. e.g. work up of symptoms suggestive of cancer
- Risk of rapidly worsening progression of disease or severity of symptoms e.g. management decisions, such as treatment for IBD
- Non-Time Sensitive: No short-term impact on patient-important outcomes e.g. screening or surveillance colonoscopy, follow up colonoscopy for +FIT
- What are the most common clinical presentations? (please choose all that apply): Upper GI bleeding, lower GI bleeding, cholangitis, suspected cancer, foreign body, relive of GI obstruction, gastrostomy, other
- Endoscopy and use of PPE:
- Did you receive appropriate education and training on infection control measures, including hand hygiene.
- Did you receive adequate training on gowning and removal of PPE?
- Do you practice Standard hand hygiene procedures before and after each case?
- What type of personal protective equipment (PPE) do you usually use for doing an endoscopic procedure nowadays? (choose all that apply) Surgical mask N95 mask Isolation gown with water resistance Head cover Eye protection Face shield N95 protection in combination with face shield or surgical mask Other (please specify): ……..
- Do you extend (over 8 hours) use of N95 masks?
- Do you re-use of N95 masks?
- Do you extend use (over 8 hours) any other equipment? : …..
- Do you re use any other equipment? …..
- If yes, please specify: …… If yes please specify: …..
- Do you use of double gloves? ……
- What PPE do you use for the following cases (choose all that apply)?
- Suspected cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- Probable cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- confirmed cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify
- Post endoscopy:
- Do you motion in your report the status of the patients (suspected, probable, confirmed case of SARS-CoV-2 infection?
- Do you use standard endoscopic decontamination or anything extra?
- Do you give time for sterilizing endoscopy room after each suspected or confirmed case of SARS-CoV-2 infection? How long?
- Do you call back your patients 2 weeks after procedure to ask them about symptoms/ diagnosis of SARS-CoV-2 infection?
- Did you report any endoscopy related SARS-CoV-2 infection in your center (anytime for HCWs \& up to two weeks after procedures for patients)?
- Are you preparing a management plan for the waiting list after the current phase of the pandemic?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Practicing gastroenterologists | – | Other: Practice detailsPracticing physicians performing gastrointestinal endoscpy |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - physicians working and practicing in gastrointestinal endoscopy units worldwide
Key inclusion criteria (1 listed)
- physicians working in endoscopy units worldwide
Key exclusion criteria (1 listed)
- physicians not working in endoscopy units worldwide
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 |
|---|---|---|
| Practice detailsPhysicians will report details of their endoscopy practice through answering the questions of the questionnaire | Other | Practicing gastroenterologists |
Primary outcome
Effect of GI societies recommendations on prevention of SARS-CoV-2 infection
Time frame: 4- 6 months
To evaluate the validity of different GI societies recommendations applied locally and how effective they are in preventing transmission in endoscopy units through reporting any new cases developing COVID-19 within two weeks of doing endoscopy (whether a patient or health-care worker)
To measure the percentage change in performed endoscopic procedure in response to COVID-19
Time frame: 4- 6 months
To measure the percentage change in performed endoscopic procedure in response to COVID-19 in different centers of the world and the alternative solutions given to overcome this problem.
6 secondary outcomes
Effect of COVID-19 precautions on procedure time
Time frame: 4- 6 months
Effect of COVID-19 precautions on time of disinfection
Time frame: 4- 6 months
Effect of COVID-19 precautions on procedure success
Time frame: 4- 6 months
Effect of COVID-19 precautions on complications
Time frame: 4- 6 months
Effect of COVID-19 precautions on working time
Time frame: 4- 6 months
Effect of COVID-19 precautions on staff number
Time frame: 4- 6 months
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 20 May 2020.
- Results publication: PubMed 21435708Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.
- Results publication: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Results publication: PubMed 32081636Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
- Results publication: PubMed 32178769Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
- Results publication: PubMed 32247018Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, Falck-Ytter Y, El-Serag HB; AGA Institute. Electronic address: ewilson@gastro.org. AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic. Gastroenterology. 2020 Aug;159(2):739-758.e4. doi: 10.1053/j.gastro.2020.03.072. Epub 2020 Apr 1. No abstract available.
- Results publication: PubMed 32241897Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020 Jun;69(6):991-996. doi: 10.1136/gutjnl-2020-321185. Epub 2020 Apr 2.
- WHO: Coronavirus Disease 2019 (COVID-19): Situation Report--51. WHO website. Published March 11, 2020. Accessed April 6, 2020.Link provided by the sponsor.
- WEO COVID-19 Response Taskforce. WEO Advice to Endoscopists. accessed April 7, 2020.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. After publication we may share data
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Al-Azhar University at 4 sites in 3 countries.
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: finished, as of the sponsor's last update on 20 May 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 Egypt, United States, Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of GI societies recommendations on prevention of SARS-CoV-2 infection (time frame: 4- 6 months). The study lists 2 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 NCT04342637, 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 20 May 2020.