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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398718
• Other study ID #: Abu Dhabi Health Services
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Abu Dhabi Health Services Company
• Contact: Nawal Al Kaabi, MD
• Phone: +97124102985
• Email: research[@]seha.ae
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Sotrovimab
collect local clinical evidence for sotrovimab effect in the real-life setting

Locations

Country	Name	City	State
Bahrain	The National Taskforce for combating COVID-19, Royal Medical Services.	Manama

Sponsors (1)

Lead Sponsor	Collaborator
Abu Dhabi Health Services Company

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	To evaluate the clinical impact of sotrovimab in preventing mortality.	Defined as All-cause mortality during 29 days after sotrovimab administration	6 months
Primary	• 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
Primary	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	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
Secondary	To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.		6 months
Secondary	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
Secondary	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