Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain

Abu Dhabi Health Services Company

Status: Unknown

Conditions: COVID-19

Treatments: Drug: Sotrovimab

Study type: Observational

Funder types: Other

Identifiers

NCT05398718

Abu Dhabi Health Services

Details and patient eligibility

About

The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)
• Mild-to-moderate COVID-19
• Positive results of direct SARS-CoV-2 viral testing
• High risk for progression to severe COVID-19

Exclusion criteria

• Patients who are hospitalised due to COVID-19 before sotrovimab administration
• Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.

Trial design

20,000 participants in 2 patient groups

Sotrovimab Arm

Treatment:

Drug: Sotrovimab

Control