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

NCT05398718 | Unknown

• 1 other identifier: Abu Dhabi Health Services
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Sotrovimab

Outcome Measures

Primary Outcomes (2)

• • 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 Outcomes (4)

• To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms

  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

  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.

  6 months

Other Outcomes (3)

• 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.

  6 months

• Quality of life of patients infused with Sotrovimab

  6 months

• To evaluate the clinical impact of sotrovimab in preventing mortality.

  6 months

Study Arms (2)

Sotrovimab Arm

Drug: Sotrovimab

Control

Interventions

Sotrovimab DRUG

collect local clinical evidence for sotrovimab effect in the real-life setting

Sotrovimab Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abu Dhabi Health Services Company: lead

Study Sites (1)

The National Taskforce for combating COVID-19, Royal Medical Services.

Manama, Bahrain

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Nawal Al Kaabi, MD

CONTACT

+97124102985; research@seha.ae

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: June 1, 2022
• Study Start: May 12, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)