Clinical trial NCT04404062: Serological and PCR Testing for COVID-19
Official title: Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Richmond Pharmacology Limited
Sponsor class: INDUSTRY
Collaborators: name: Richmond Pharmacology Limited
First posted: 2020-05-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of carriers of SARS-CoV-2
timeFrame: Through study completion, estimated 12 weeks
Secondary outcomes:
measure: Determination of the duration of immunity to SARS-CoV-2
timeFrame: Through study completion, estimated 12 weeks
measure: Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2
timeFrame: Through study completion, estimated 12 weeks
measure: Exploration of SARS-CoV-2 epidemiology
timeFrame: Through study completion, estimated 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
Study officials:
affiliation: Richmond Pharmacology Limited
name: Jorg Taubel, MD
role: PRINCIPAL_INVESTIGATOR
References: