Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) (EHS-Strategy)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Respiratory Infection

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 Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Ghada ali; Phone Number: 00971505194990; Email: ghada.ali@ehs.gov.ae

Study Locations

• United Arab Emirates
  • Dubai, United Arab Emirates
    • Recruiting
    • Emirats Health Service
    • Contact: Ghada ali; Phone Number: 00971505194990; Email: ghada.ali@ehs.gov.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mild and moderated COVID -19 patient treated out side the hospital sitting; Reviewing files of such group that had been received Sotrovimab

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emirates Health Services (EHS)
• Investigators: Principal Investigator: sumaya abdalateef, Emirats Health Service (EHS)

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): February 9, 2022

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Sotrovimab; UAE experience; Emirates health service EHS strategy; Out patient treatment for COVID
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: No.108/ 2021.EHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No