Coronavirus Disease (COVID-19)SARAHNCT04348214
Screening & Risk Assessment of Healthcare Workers & Infection Control in University & COVID-19 Quarantine Hospitals
An observational study of Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
Trial summary
A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- How many people
- 4,040 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2020to 1 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: All staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals
Who may be able to join
- All staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
About this study
Official title: Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management
A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
Read the detailed description
Research Approach and Methodology
- Healthcare workers' risk and 2. Infection prevention and control needs: Study design and setting
To fulfill specific objectives, a prospective investigation of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals.
To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently.
Study population For the purpose of this study, HCWs are defined as all staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. These include those who have been present in the same area as the patient, as well as those who may not have provided direct care to the patient, but who have had contact with the patient's body fluids, potentially contaminated items or environmental surfaces. This includes health care professionals, allied health workers, auxiliary health workers (e.g. cleaning and laundry personnel, x-ray physicians and technicians, clerks, phlebotomists, respiratory therapist, nutritionists, social workers, physical therapists, lab personnel, cleaners, admission/reception clerks, patient transporters, catering staff etc.). Once a case of COVID-19 has been identified in these hospitals, a list of all health care workers with any exposure to COVID-19 patient will need to be drawn up.
Study tool and data collection For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals.
The questionnaire will be adapted from the World Health Organization relevant protocols and interim guidance. The sections of the questionnaire will cover:
- Socio-demographic, background information including history of tobacco use, and pre-existing medical conditions;
- COVID-19 virus exposure risk assessment for community exposure;
- COVID-19 virus exposure risk assessment for nosocomial exposure (i.e. contact and possible exposure with the COVID-19 patients since the patient has been admitted to the health care facility);
- HCW interactions with COVID-19 patient information;
- HCW activities performed on COVID-19 patient in health care facility;
- HCW symptoms;
- Adherence to infection prevention and control measures during health care interactions;
- Adherence to infection prevention and control measures when performing aerosol-generating procedures (e.g. tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheotomy, bronchoscopy, cardiopulmonary resuscitation, etc.); and
- Accidents with biological material.
This online survey will be completed at baseline and at any future contact or possible exposure with the COVID-19 patients since the patient has been admitted to the hospital.
Other forms will complement the data collected in the online survey questionnaire. The complementary forms include:
- Laboratory form for specimen collection for screening and testing and the relevant results
- Follow-up laboratory form for specimen collection for screening and testing and the relevant results
- HCW symptom diary: Each HCW contact will be asked to record the presence or absence of various signs or symptoms each day for up to 21 days after the administration of the baseline questionnaire (minimum 14 days).
- Outcome form for follow up of HCWs who experience contact or possible exposure with the COVID-19 patients since the patient has been admitted to the hospital.
- Health care facility infection prevention and control form: filled once at baseline for each of the study hospitals.
These will be filled by HCWs, and dedicated teams and coordinators representing the hospital infection control focal points and the hospital management at each of the study hospitals. The forms will be electronically linked to the online survey for instant updates of HCW information using an automatically generated unique serial study number for each HCW to be used across all study forms.
- Testing for COVID-19 among healthcare workers:
For confirmation of seroconversion, determination of the secondary-infection attack rate, and the proportion of asymptomatic infection paired serological samples will be collected:
- A baseline serum sample will be collected from all healthcare workers with any exposure (regardless of symptoms), as soon as possible after confirmation of a COVED-19 infected patient in the hospital.
- A second serum sample will be collected from the same healthcare workers at least 21 days after the collection of the first serum sample
For measuring the validity of the available rapid serological tests:
A respiratory sample will be taken for viral detection by RT-PCR
- Geospatial mapping of health care workers' risk and infection control needs:
To achieve this aim the following subtasks must be done:
- Build a full stack web-based platform that is integrated with a geographical information system. Where, the platform frontend is a real-time interactive map.
Moreover, the platform backend is a database system to store and manipulate the HCWs' risk and infection control data.
- Build a real-time Signal-R flagging service to track the survey results and put flags on the platform interactive map where these flags represent the location of high HCWs' risk and infection control rate.
- Build a real-time reporting service based on Signal-R and Artificial Intelligence techniques to follow up the survey results and inform the policy and the decision makers with the location and information of the high HCWs' risk and infection control rate.
Furthermore, this reporting service provides more insights on the survey results using the Artificial Intelligence techniques such as the association between the geographical information and the high HCWs' risk rate.
- Conditions
- Coronavirus Disease (COVID-19)
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk categorization of healthcare workers
To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals
Measured: 9 months
COVID-19 infection rate among health care workers
To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.
Measured: 9 months
Risk factors for COVID-19 among health care workers
To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.
Measured: 9 months
Adherence of health care workers to infection prevention
To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.
Measured: 9 months
Validity of the available rapid serological test for detecting COVID-19 virus infection
To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.
Measured: 9 months
Secondary outcomes (5)
Clinical spectrum of COVID-19
To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.
Measured: 9 months
Effectiveness of infection prevention in the health care facility
To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measured: 9 months
Emergency infection prevention and control needs
To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measured: 9 months
Isolation rate and emergency health care worker replacement needs
To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.
Measured: 9 months
Rate of seroconversion
To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start22 Apr 2020
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 4,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mostafa, Ain Shams University
- Investigators
- Aya Mostafa, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348214
- Sponsor's protocol ID
- FMASU P18a/ 2020
- Acronym
- SARAH
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Algohary E, Fahmy G, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Elanwar A, Saleh A, Mansour O, Omar A, El-Meteini M. SARS-CoV-2 seroconversion among 4040 Egyptian healthcare workers in 12 resource-limited healthcare facilities: A prospective cohort study. Int J Infect Dis. 2021 Mar;104:534-542. doi: 10.1016/j.ijid.2021.01.037. Epub 2021 Jan 20.
PubMed 33484863Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Saleh A, Mansour O, Omar A, El-Meteini M. Universal COVID-19 screening of 4040 health care workers in a resource-limited setting: an Egyptian pilot model in a university with 12 public hospitals and medical centers. Int J Epidemiol. 2021 Mar 3;50(1):50-61. doi: 10.1093/ije/dyaa173.
PubMed 33094320
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management
- ClinicalTrials.gov ID
- NCT04348214
- Acronym / sponsor ID
- SARAH / FMASU P18a/ 2020
- Conditions
- Coronavirus Disease (COVID-19)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,040 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 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 prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
Detailed description
Research Approach and Methodology
- Healthcare workers' risk and 2. Infection prevention and control needs: Study design and setting
To fulfill specific objectives, a prospective investigation of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals.
To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently.
Study population For the purpose of this study, HCWs are defined as all staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. These include those who have been present in the same area as the patient, as well as those who may not have provided direct care to the patient, but who have had contact with the patient's body fluids, potentially contaminated items or environmental surfaces. This includes health care professionals, allied health workers, auxiliary health workers (e.g. cleaning and laundry personnel, x-ray physicians and technicians, clerks, phlebotomists, respiratory therapist, nutritionists, social workers, physical therapists, lab personnel, cleaners, admission/reception clerks, patient transporters, catering staff etc.). Once a case of COVID-19 has been identified in these hospitals, a list of all health care workers with any exposure to COVID-19 patient will need to be drawn up.
Study tool and data collection For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals.
The questionnaire will be adapted from the World Health Organization relevant protocols and interim guidance. The sections of the questionnaire will cover:
- Socio-demographic, background information including history of tobacco use, and pre-existing medical conditions;
- COVID-19 virus exposure risk assessment for community exposure;
- COVID-19 virus exposure risk assessment for nosocomial exposure (i.e. contact and possible exposure with the COVID-19 patients since the patient has been admitted to the health care facility);
- HCW interactions with COVID-19 patient information;
- HCW activities performed on COVID-19 patient in health care facility;
- HCW symptoms;
- Adherence to infection prevention and control measures during health care interactions;
- Adherence to infection prevention and control measures when performing aerosol-generating procedures (e.g. tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheotomy, bronchoscopy, cardiopulmonary resuscitation, etc.); and
- Accidents with biological material.
This online survey will be completed at baseline and at any future contact or possible exposure with the COVID-19 patients since the patient has been admitted to the hospital.
Other forms will complement the data collected in the online survey questionnaire. The complementary forms include:
- Laboratory form for specimen collection for screening and testing and the relevant results
- Follow-up laboratory form for specimen collection for screening and testing and the relevant results
- HCW symptom diary: Each HCW contact will be asked to record the presence or absence of various signs or symptoms each day for up to 21 days after the administration of the baseline questionnaire (minimum 14 days).
- Outcome form for follow up of HCWs who experience contact or possible exposure with the COVID-19 patients since the patient has been admitted to the hospital.
- Health care facility infection prevention and control form: filled once at baseline for each of the study hospitals.
These will be filled by HCWs, and dedicated teams and coordinators representing the hospital infection control focal points and the hospital management at each of the study hospitals. The forms will be electronically linked to the online survey for instant updates of HCW information using an automatically generated unique serial study number for each HCW to be used across all study forms.
- Testing for COVID-19 among healthcare workers:
For confirmation of seroconversion, determination of the secondary-infection attack rate, and the proportion of asymptomatic infection paired serological samples will be collected:
- A baseline serum sample will be collected from all healthcare workers with any exposure (regardless of symptoms), as soon as possible after confirmation of a COVED-19 infected patient in the hospital.
- A second serum sample will be collected from the same healthcare workers at least 21 days after the collection of the first serum sample
For measuring the validity of the available rapid serological tests:
A respiratory sample will be taken for viral detection by RT-PCR
- Geospatial mapping of health care workers' risk and infection control needs:
To achieve this aim the following subtasks must be done:
- Build a full stack web-based platform that is integrated with a geographical information system. Where, the platform frontend is a real-time interactive map.
Moreover, the platform backend is a database system to store and manipulate the HCWs' risk and infection control data.
- Build a real-time Signal-R flagging service to track the survey results and put flags on the platform interactive map where these flags represent the location of high HCWs' risk and infection control rate.
- Build a real-time reporting service based on Signal-R and Artificial Intelligence techniques to follow up the survey results and inform the policy and the decision makers with the location and information of the high HCWs' risk and infection control rate.
Furthermore, this reporting service provides more insights on the survey results using the Artificial Intelligence techniques such as the association between the geographical information and the high HCWs' risk rate.
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
- All staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals
Key inclusion criteria (1 listed)
- All staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals
Key exclusion criteria (1 listed)
- None
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
Risk categorization of healthcare workers
Time frame: 9 months
To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals
COVID-19 infection rate among health care workers
Time frame: 9 months
To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.
Risk factors for COVID-19 among health care workers
Time frame: 9 months
To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.
Adherence of health care workers to infection prevention
Time frame: 9 months
To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.
Validity of the available rapid serological test for detecting COVID-19 virus infection
Time frame: 9 months
To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.
5 secondary outcomes
Clinical spectrum of COVID-19
Time frame: 9 months
Effectiveness of infection prevention in the health care facility
Time frame: 9 months
Emergency infection prevention and control needs
Time frame: 9 months
Isolation rate and emergency health care worker replacement needs
Time frame: 9 months
Rate of seroconversion
Time frame: 9 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 Apr 2021.
- Results publication: PubMed 33484863Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Algohary E, Fahmy G, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Elanwar A, Saleh A, Mansour O, Omar A, El-Meteini M. SARS-CoV-2 seroconversion among 4040 Egyptian healthcare workers in 12 resource-limited healthcare facilities: A prospective cohort study. Int J Infect Dis. 2021 Mar;104:534-542. doi: 10.1016/j.ijid.2021.01.037. Epub 2021 Jan 20.
- Results publication: PubMed 33094320Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Saleh A, Mansour O, Omar A, El-Meteini M. Universal COVID-19 screening of 4040 health care workers in a resource-limited setting: an Egyptian pilot model in a university with 12 public hospitals and medical centers. Int J Epidemiol. 2021 Mar 3;50(1):50-61. doi: 10.1093/ije/dyaa173.
- Individual participant dataSharing planned: No
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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.
Aya Mostafa principal investigator
Ain Shams University
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 Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
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 Apr 2021. 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 Egypt. 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?
Risk categorization of healthcare workers (time frame: 9 months). The study lists 5 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 NCT04348214, which also lists 2 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 Apr 2021.