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.
Study Type
OBSERVATIONAL
Enrollment
20,000
collect local clinical evidence for sotrovimab effect in the real-life setting
The National Taskforce for combating COVID-19, Royal Medical Services.
Manama, Bahrain
RECRUITING• 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
Time frame: 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
Time frame: 6 months
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
Time frame: 6 months
To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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