Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

NCT05144178 | Unknown DMC

• 1 other identifier: No.108/ 2021.EHS
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection

Keywords

Sotrovimab; UAE experience; Emirates health service EHS strategy; Out patient treatment for COVID

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Reviewing files of such group that had been received Sotrovimab

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All cases received Sotrovimab according the EUA protocol.
• All patient aged 13 and above

You may not qualify if:

• Sever form of the COVID-19 disease
• Hospitalized patient
• Age less than 13 years old
• BMI less than 25 and no risk factors

Sponsors & Collaborators

• Emirates Health Services (EHS): lead

Study Sites (1)

Emirats Health Service

Dubai, United Arab Emirates

RECRUITING

Study Officials

• sumaya abdalateef

  Emirats Health Service (EHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ghada Ali

CONTACT

00971505194990; ghada.ali@ehs.gov.ae

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 3, 2021
• Study Start: November 14, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 9, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

AE (1)