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

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

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 Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: Sotrovimab

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Nawal Al Kaabi, MD; Phone Number: +97124102985; Email: research@seha.ae

Study Locations

• Bahrain
  • Manama, Bahrain
    • Recruiting
    • The National Taskforce for combating COVID-19, Royal Medical Services.
    • Contact: Manaf Al Qahtani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with mild-to-moderate COVID-19 as confirmed by approved local laboratory tests

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control
Sotrovimab Arm	Drug: Sotrovimab; collect local clinical evidence for sotrovimab effect in the real-life setting

What is the study measuring?

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 oxygenRequiring ICU and/or general ward admissionDeath; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Defined as: Proportion of COVID-19 patients who had ER visits for management of illness, for requirement of supplemental oxygen and/or ICU admission through Day 29 after sotrovimab administration.	6 months
Quality of life of patients infused with Sotrovimab	Defined as Change from baseline in health-related quality of life at Day 29 after sotrovimab administration according to the 20-item short form (SF-20) questionnaire (where available / in a selected fraction of patients only in the prospective arm). The questionnaire contains items on physical functioning, role functioning, social functioning, mental health, health perception and pain, the score of all measures is transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, respectively. a high score indicates better health	6 months
To evaluate the clinical impact of sotrovimab in preventing mortality.	Defined as All-cause mortality during 29 days after sotrovimab administration	6 months

Collaborators and Investigators

• Sponsor: Abu Dhabi Health Services Company

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Sotrovimab
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Abu Dhabi Health Services

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No