COVID-19 Respiratory InfectionEHS-StrategyNCT05144178
Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )
An observational study of COVID-19 Respiratory Infection, run by Emirates Health Services (EHS) at 1 site in United Arab Emirates.
Trial summary
Sotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection
- How many people
- 3,500 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 14 Nov 2021to 9 Feb 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The source population will consist of individuals residing in UAE ,infected with SARS-CoV-2 and developed mild or moderate symptoms and are high risk . High risk patients are defined as meeting at least 1 of the following criteria: 1. BMI ≥ 25 2. Chronic kidney disease 3. Diabetes 4. Immunosuppressive disease 5. Receiving immunosuppressive treatment 6. Age ≥ 65 years 7. Age ≥ 55 years and have cardiovascular disease, hypertension, or COPD/chronic respiratory disease. 8. pregnancy
Who may be able to join
- All cases received Sotrovimab according the EUA protocol.
- All patient aged 13 and above
Who cannot join
- Sever form of the COVID-19 disease
- Hospitalized patient
- Age less than 13 years old
- BMI less than 25 and no risk factors
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Emirats Health Service
Dubai
Ghada ali, 00971505194990, ghada.ali@ehs.gov.ae
About this study
Official title: Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) as Part of Emirats Health Service (EHS)Fighting Strategy Against COVID-19.
Sotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.
The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
As the clinical trial results are too preliminary for the drug to enter routine use in UAE the drug approved only for emergency use, until further evidence shows Sotrovimab is effective, so we thought about this study as a tool to assess the success of Emirats Health service (EHS) strategy for fighting against COVID-19 outside the hospital setting.
Read the detailed description
May 26, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19), as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
May 28,2021 the UAE Ministry of Health and Prevention approved the investigational drug for emergency use, and Emirats health service considered strategy for fighting against COVID-19 outside the hospital setting, based on this strategy ,special protocol was finalized and approved including initiation of infusion units for the drug in EHS hospital and primary health care centers, all Infection Prevention and Control Precautions were taken inconsideration .
The overall aim of this study is to determine the effectiveness of Sotrovimab infusion in cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization, in UAE. We expect to assess the Proportion of patients who have progression of COVID-19 through 28 days as defined by visit to a hospital emergency room for management or illness, or hospitalization more than 24 h for acute management of illness or death. files of patients treated from June 2021 till October 2021 will be reviewed and data will be collected based on the protocol approved from MOHAP ethical committee.
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Sotrovimab, UAE experience, Emirates health service EHS strategy, Out patient treatment for COVID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild and moderated COVID -19 patient treated out side the hospital sitting | Reviewing files of such group that had been received Sotrovimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of hospital admission from total number of reviewed patient
Admission to hospital with progressive COVID -19 more than 24h
Measured: 10 days
percent of Death among total number of reviewed patient
mortality post treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start14 Nov 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion9 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emirates Health Services (EHS)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sumaya Abdalateef, Emirates Health Services (EHS)
- Investigators
- sumaya abdalateef, Principal investigator, Emirats Health Service (EHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144178
- Sponsor's protocol ID
- No.108/ 2021.EHS
- Acronym
- EHS-Strategy
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) as Part of Emirats Health Service (EHS)Fighting Strategy Against COVID-19.
- ClinicalTrials.gov ID
- NCT05144178
- Acronym / sponsor ID
- EHS-Strategy / No.108/ 2021.EHS
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Sotrovimab, UAE experience, Emirates health service EHS strategy, Out patient treatment for COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Emirates Health Services (EHS)Other government
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 9 Feb 2022 (estimated)
- First posted
- 3 Dec 2021 (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.
Sotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.
The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
As the clinical trial results are too preliminary for the drug to enter routine use in UAE the drug approved only for emergency use, until further evidence shows Sotrovimab is effective, so we thought about this study as a tool to assess the success of Emirats Health service (EHS) strategy for fighting against COVID-19 outside the hospital setting.
Detailed description
May 26, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19), as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
May 28,2021 the UAE Ministry of Health and Prevention approved the investigational drug for emergency use, and Emirats health service considered strategy for fighting against COVID-19 outside the hospital setting, based on this strategy ,special protocol was finalized and approved including initiation of infusion units for the drug in EHS hospital and primary health care centers, all Infection Prevention and Control Precautions were taken inconsideration .
The overall aim of this study is to determine the effectiveness of Sotrovimab infusion in cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization, in UAE. We expect to assess the Proportion of patients who have progression of COVID-19 through 28 days as defined by visit to a hospital emergency room for management or illness, or hospitalization more than 24 h for acute management of illness or death. files of patients treated from June 2021 till October 2021 will be reviewed and data will be collected based on the protocol approved from MOHAP ethical committee.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild and moderated COVID -19 patient treated out side the hospital sitting | – | –Reviewing files of such group that had been received Sotrovimab |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The source population will consist of individuals residing in UAE ,infected with SARS-CoV-2 and developed mild or moderate symptoms and are high risk . High risk patients are defined as meeting at least 1 of the following criteria: 1. BMI ≥ 25 2. Chronic kidney disease 3. Diabetes 4. Immunosuppressive disease 5. Receiving immunosuppressive treatment 6. Age ≥ 65 years 7. Age ≥ 55 years and have cardiovascular disease, hypertension, or COPD/chronic respiratory disease. 8. pregnancy
Key inclusion criteria (2 listed)
- All cases received Sotrovimab according the EUA protocol.
- All patient aged 13 and above
Key exclusion criteria (4 listed)
- Sever form of the COVID-19 disease
- Hospitalized patient
- Age less than 13 years old
- BMI less than 25 and no risk factors
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
percent of hospital admission from total number of reviewed patient
Time frame: 10 days
Admission to hospital with progressive COVID -19 more than 24h
percent of Death among total number of reviewed patient
Time frame: 28 days
mortality post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- 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.
sumaya abdalateef principal investigator
Emirats Health Service (EHS)
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 Respiratory Infection, run by Emirates Health Services (EHS) at 1 site 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 2 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 3 Jan 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 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 ghada Ali (00971505194990, ghada.ali@ehs.gov.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of hospital admission from total number of reviewed patient (time frame: 10 days). 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?
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 Jan 2022.