Serological and PCR Testing for COVID-19

NCT04404062 | Recruiting

• 1 other identifier: C20010
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Determination of the duration of immunity to SARS-CoV-2

  Through study completion, estimated 12 weeks

• Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2

  Through study completion, estimated 12 weeks

• Exploration of SARS-CoV-2 epidemiology

  Through study completion, estimated 12 weeks

Study Arms (1)

Trial Participants

Male and female participants aged 5-70 years

Diagnostic Test: Membrane-based immunoassay kit; Diagnostic Test: Quantitative antibody Tests; Diagnostic Test: PCR Test

Interventions

Membrane-based immunoassay kit DIAGNOSTIC_TEST

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.

Also known as: Covid-19 Rapid Test Kit

Trial Participants

Quantitative antibody Tests DIAGNOSTIC_TEST

Antibody titres will be measured from whole blood samples taken from volunteers.

Also known as: Antibody titre

Trial Participants

PCR Test DIAGNOSTIC_TEST

PCR tests will be conducted on throat swabs taken from volunteers.

Trial Participants

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are individuals who are screened upon entry to the Richmond Pharmacology unit. These individuals may be employees of Richmond Pharmacology, volunteers for other concurrent studies, or members of the public.

You may qualify if:

• Male or female aged 5 to 70 years.
• An understanding, ability, and willingness to fully comply with the project procedures and restrictions.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• Richmond Research Institute: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge

London, London, SE1 1YR, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Jorg Taubel, MD

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorg Taubel, MD

CONTACT

+44(0)2070425800; j.taubel@richmondpharmacology.com

Ulrike Lorch, MD

CONTACT

+44(0)2038482005; u.lorch@richmondpharmacology.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: March 16, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)