Clinical trial NCT05398718: Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Sotrovimab
Lead sponsor: Abu Dhabi Health Services Company
Sponsor class: OTHER_GOV
First posted: 2022-06-01
Enrollment: 20000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with mild-to-moderate COVID-19 as confirmed by approved local laboratory tests

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: • Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms
timeFrame: 6 months
measure: To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.
timeFrame: 6 months
measure: To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
measure: To evaluate the impact of sotrovimab on incidence and duration of time for supplemental oxygen, length of stay (LOS) in the intensive care unit (ICU), and total hospital LOS.
timeFrame: 6 months
measure: Quality of life of patients infused with Sotrovimab
timeFrame: 6 months
measure: To evaluate the clinical impact of sotrovimab in preventing mortality.
timeFrame: 6 months
Locations:
city: Manama
country: Bahrain
facility: The National Taskforce for combating COVID-19, Royal Medical Services.
Study officials:
References: