Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

NCT ID: NCT05144178

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-14
• Study Completion Date: 2022-02-09

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.

Conditions

COVID-19 Respiratory Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Mild and moderated COVID -19 patient treated out side the hospital sitting

Reviewing files of such group that had been received Sotrovimab

No interventions assigned to this group

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emirates Health Services (EHS)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Sumaya Abdalateef

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sumaya abdalateef

Role: PRINCIPAL_INVESTIGATOR

Emirats Health Service (EHS)

Locations

Emirats Health Service

Dubai, , United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

Central Contacts

ghada Ali

Role: CONTACT

ghada.ali@ehs.gov.ae

00971505194990

Facility Contacts

Ghada ali

Role: primary

ghada.ali@ehs.gov.ae

00971505194990

Other Identifiers

No.108/ 2021.EHS

Identifier Type: -

Identifier Source: org_study_id