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

NCT ID: NCT05398718

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Sotrovimab Arm

Sotrovimab

Intervention Type DRUG

collect local clinical evidence for sotrovimab effect in the real-life setting

Control

No interventions assigned to this group

Interventions

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Sotrovimab

collect local clinical evidence for sotrovimab effect in the real-life setting

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abu Dhabi Health Services Company

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The National Taskforce for combating COVID-19, Royal Medical Services.

Manama, , Bahrain

Site Status RECRUITING

Countries

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Bahrain

Central Contacts

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Nawal Al Kaabi, MD

Role: CONTACT

+97124102985

Facility Contacts

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Manaf Al Qahtani, MD

Role: primary

Other Identifiers

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Abu Dhabi Health Services

Identifier Type: -

Identifier Source: org_study_id

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