Clinical trial NCT05144178: Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )
Official title: Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) as Part of Emirats Health Service (EHS)Fighting Strategy Against COVID-19.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Respiratory Infection
Keywords: Sotrovimab
UAE experience
Emirates health service EHS strategy
Out patient treatment for COVID
Lead sponsor: Emirates Health Services (EHS)
Sponsor class: OTHER_GOV
First posted: 2021-12-03
Enrollment: 3500
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: percent of hospital admission from total number of reviewed patient
timeFrame: 10 days
measure: percent of Death among total number of reviewed patient
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Emirats Health Service
Study officials:
affiliation: Emirats Health Service (EHS)
name: sumaya abdalateef
role: PRINCIPAL_INVESTIGATOR
References: