Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

Study Overview
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Brief Summary
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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
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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.

Official Title
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Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) as Part of Emirats Health Service (EHS)Fighting Strategy Against COVID-19.

Conditions
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COVID-19 Respiratory Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All cases received Sotrovimab according the EUA protocol. All patient aged 13 and above Exclusion Criteria: Sever form of the COVID-19 disease Hospitalized patient Age less than 13 years old BMI less than 25 and no risk factors

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild and moderated COVID -19 patient treated out side the hospital sitting<br>Reviewing files of such group that had been received Sotrovimab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of hospital admission from total number of reviewed patient | Admission to hospital with progressive COVID -19 more than 24h | 10 days | 
| percent of Death among total number of reviewed patient | mortality post treatment | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sotrovimab, UAE experience, Emirates health service EHS strategy, Out patient treatment for COVID