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

Study Overview
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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.

Official Title
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Bi-directional Real-world Cohort Study on Sotrovimab and Its Impact on the Strength and Duration of the Immune Response to Natural SARS-CoV-2 Infection in Real-life Setting in the UAE and the Kingdom of Bahrain

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Sotrovimab


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sotrovimab Arm<br> | Drug: Sotrovimab<br>* collect local clinical evidence for sotrovimab effect in the real-life setting<br>|
| Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration: | Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration: Requiring supplemental oxygen Requiring ICU and/or general ward admission Death Time to first PCR negative status after the COVID-19 symptom onset Time to first PCR negative status after date of sotrovimab administration | 6 months | 
| To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain. | Defined as • Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration, these will be presented as proportion of patients with that response | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms | Time to key clinical symptoms alleviation from symptom onset and sotrovimab administration at baseline, Day 29 after sotrovimab administration and Day of symptoms free (for all 350 patients in the interventional phase and part of the patients in the observational phase). Key clinical symptoms alleviation is defined as the clinical resolution of shortness of breath, fever, and body ache | 6 months | 
| To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression. |  | 6 months | 
| To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain | Defined as: Occurrence of adverse events (AEs) and serious adverse events (SAEs) through Day 29 after sotrovimab administration . Proportion of patients with AEs and SAEs through Day 29 after sotrovimab administration. | 6 months | 
| To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain. | Defined as: • Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration in patients, who received their complete or incomplete vaccination course within 3 months prior to COVID-19 symptom onset, these will be presented as proportion of patients with that response. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sotrovimab