Serological and PCR Testing for COVID-19

COVID-19 Clinical Trial

Official title:

Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404062
• Other study ID #: C20010
• Status: Recruiting
• Start date: March 16, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Richmond Pharmacology Limited
• Contact: Jorg Taubel, MD
• Phone: +44(0)2070425800
• Email: j.taubel[@]richmondpharmacology.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody tests to help develop methodologies which provide fast and accurate results. Infection with coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19 is crucial to understand who is infected and therefore a risk to others by spreading the infection. RRI are currently carrying out the following tests:

A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune

B. Polymerase Chain Reaction (PCR) testing using an established method to check for active SARS-CoV-2 infections.

C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.

The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their workforce, as well as their families (including children) and visitors to their site.

Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission.

Description:

This is a screening study to measure symptomatic and asymptomatic carriage of SARS-CoV-2 in trial participants to help facilitate early detection of a second wave of SARS-CoV-2 infections. Specifically, this study aims to determine ; to assess the duration of immunity by assessing the number and speed at which trial participants were infected and cleared the virus with or without symptoms; and to determine the length of symptom onset in those with an active infection; levels of IgG antibodies by demographics (sex, age, ethnicity, and intensity of symptoms). Longitudinal assessment of antibody levels will additionally allow for assessment of the efficacy of any vaccines adminstered. This study also seeks to explore how many people are asymptomatic carriers. In addition, this study aims to help facilitate the development a quantitative laboratory reference test for antibodies (IgG).

By using multiple different tests, it can be determined if a person is currently infected with SARS-CoV-2 or whether they previously have been infected. This allows for the scanning of people with asymptomatic carriage of the virus, which is important to help reduce the spread of SARS-CoV-2 through contact with people unaware of infection.

Polymerase Chain Reaction (PCR) testing is routinely used to check for active SARS-CoV-2 infections. It measures whether viral RNA is present in an individual's system. All in-house PCR tests are verified by an independent laboratory to check for false positives.

Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune. IgG and IgM detection components are separate allowing for differential detection of each antibody.

To this date, 20904 PCR tests and 6848 antibody tests have been carried out in 2328 individuals, providing some interim data. Of the 20904 PCR tests, 17635 (84%) were negative and 132 (1%) were negative. Of the 6848 antibody tests, 706 (10%) were positive for IgG only, 64 (1%) were positive for IgM only, and 351 (5%) were positive for both IgG and IgM. 5710 (83%) tests were negative.

Of those individuals with a positive PCR test, 53% reported fever during the previous two months and 75% reported a loss of taste during the previous two months.

Interim results are shown in the medRxiv papers below:

https://www.medrxiv.org/content/10.1101/2020.12.08.20245894v2

https://www.medrxiv.org/content/10.1101/2021.04.09.21255200v1

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female aged 5 to 70 years.

• An understanding, ability, and willingness to fully comply with the project procedures and restrictions.

Exclusion Criteria:

• Not applicable.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Membrane-based immunoassay kit
The kit is a qualitative membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. IgG and IgM detection components are separate allowing for differential detection of each antibody.
• Quantitative antibody Tests
Antibody titres will be measured from whole blood samples taken from volunteers.
• PCR Test
PCR tests will be conducted on throat swabs taken from volunteers.

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge	London

Sponsors (2)

Lead Sponsor	Collaborator
Richmond Research Institute	Richmond Pharmacology Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of carriers of SARS-CoV-2	To identify trial participants who are symptomatic or asymptomatic carriers of SARS-CoV-2 by comparing the results of a blood finger stick test and reference laboratory tests to PCR testing for acute infection	Through study completion, estimated 12 weeks
Secondary	Determination of the duration of immunity to SARS-CoV-2	To determine the duration of immunity of trial participants previously infected with SARS-CoV-2, measure differences in IgG antibodies by demographics including sex, ethnicity and age and investigate correlation between IgG antibody levels and intensity of symptoms	Through study completion, estimated 12 weeks
Secondary	Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2	Determination of the understanding of the quantity of IgG antibodies developed as a response to SARS-CoV-2 infection, and how these antibody levels decrease over time. Antibody titres will be measured in infected individuals, over multiple days and correlated with disease parameters. This will facilitate the development of a quantitative laboratory reference test for IgG antibodies	Through study completion, estimated 12 weeks
Secondary	Exploration of SARS-CoV-2 epidemiology	To help develop a quantitative laboratory reference test for antibodies (IgG) to gain an understanding of quantity of antibodies that people develop and how these decrease over time.	Through study completion, estimated 12 weeks