SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort

Covid19 Clinical Trial

— SCAPE-HIV  

Official title:

SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067400
• Other study ID #: 1
• Status: Completed
• Start date: April 21, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants

Description:

The main aim of this study is to find out how many people living with HIV (PLWH) attending a major HIV centre in London, have already been infected with SARS-CoV2 so far which will be determined through serological blood tests detecting the presence of antibodies to SARS-CoV2, or have developed antibodies in response to vaccination.

However, it is not know whether the presence of antibodies from natural infection means anything more than a marker that someone has been exposed to SARS-CoV2 previously. It is not know whether this means someone is any less likely to be reinfected in the future or how it will affect possible future infections with SARS-CoV2. Whilst further data on natural and vaccine induced antibody responses is awaited, those with the presence of anti-SARS-CoV2 antibodies continue to be advised to take the same precautions as everyone else in terms of reducing the risk of getting COVID-19: regularly washing hands, wearing a mask and remaining socially distant where possible.

Now that vaccination has commenced it is also unclear what markers of vaccine induced immunity will develop, including in PLWH. This study will help better determine whether HIV should be an additional 'priority' group for vaccination, and also what antibody responses exist in PLWH who have been vaccinated

The intention is to invite the cohort in for an annual set of HIV related blood tests, covering those who are scheduled for bloods, as well as those who may have missed scheduled blood monitoring appointments during the COV19 lockdown period. In addition to these tests the study proposes offering serological testing for SARS CoV-2 as part of this surveillance study. Participation will be voluntary, and informed consent will be obtained. Participants will be informed of their result along with information about the uncertainty of its meaning, beyond indicating previous infection or vaccination.

The study aims to test for the presence of specific antibodies that target SARS-CoV2 in people living with HIV, as a marker of whether someone has been infected before. This will help create a better understanding of whether living with HIV puts people at a higher risk of becoming infected with SARS-CoV2 compared to the general population, and which other factors or characteristics may affect this risk. This will help identify who might be more at risk of getting COVID-19 in the future and will help plan for future COVID-19 vaccine strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented HIV infection

• Registered patient at ICDC

• Age =18 years at study entry

• Able to comprehend study patient information leaflet

Exclusion Criteria:

• Unable to give informed consent and participant without a good understanding of verbal and written English

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• HIV-1-infection
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust	Roche Diagnostics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reporting of previous SARS-CoV2 infection (reported history)	Reported history of positive SARS CoV2 test since 1 Jan 2020	Since 1st Jan 2020
Other	History of SARS CoV2 vaccine	Reported history of receiving a SARS CoV2 vaccine (no, 1 dose, 2 dose)	Since 1st Jan 2020
Primary	Prevalence of SARS-CoV2 antibodies	The primary outcome measure is the presence of antibodies to SARS-CoV2. This is a binary outcome (present/absent)	Since 1st Jan 2020
Secondary	Reporting of COVID symptoms	The secondary outcome measure is the reporting of previous COVID symptoms since 1st January 2020. This is a binary measure (yes/no).	Since 1st Jan 2020