By Clinical Research News Staff

April 14, 2020 | The National Institutes of Health announced a new study last week to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have antibodies to the virus indicating a prior infection.

“This study will give us a clearer picture of the true magnitude of the COVID-19 pandemic in the United States by telling us how many people in different communities have been infected without knowing it, because they had a very mild, undocumented illness or did not access testing while they were sick,” said Anthony S. Fauci, M.D., NIAID director, in the statement announcing the study. “These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”

In this “serosurvey,” researchers will collect and analyze blood samples from as many as 10,000 volunteers to provide critical data for epidemiological models. The results will help illuminate the extent to which the novel coronavirus has spread undetected in the United States and provide insights into which communities and populations are most affected.

Investigators will test participants’ blood samples for the presence of SARS-CoV-2 antibodies, proteins the immune system produces to fight a specific infectious agent. A positive test result indicates previous infection. To date, reporting of U.S. cases of COVID-19 has mostly relied on molecular tests that determine the presence of the virus in a person’s airways using a noninvasive cotton swab. While these cotton swab-based tests rapidly and effectively identify active infection, they do not determine whether a person was previously infected with SARS-CoV-2 and recovered.

Investigators will analyze blood samples for two types of antibodies, anti-SARS-CoV-2 S protein IgG and IgM, using an ELISA (enzyme-linked immunosorbent assay) developed by researchers at NIAID and NIBIB. In blood samples found to contain antibodies against SARS-CoV-2, researchers may perform additional tests to evaluate the volunteers’ immune responses to the virus. These data may provide insight as to why these cases were less severe than those that lead to hospitalization.

All Remote Trial

Healthy volunteers over the age of 18 from anywhere in the United States can participate and will be asked to consent to enrollment over the telephone. Individuals with a confirmed history of COVID-19 or current symptoms consistent with COVID-19 are not eligible to participate.

After enrollment, study participants will attend a virtual clinic visit, complete a health assessment questionnaire and provide basic demographic information—including race, ethnicity, sex, age and occupation—before submitting samples in one of two ways. Participants working at the NIH Bethesda campus will have blood drawn at the NIH Clinical Center. Other volunteers will participate in at-home blood sampling. Neoteryx, a medical device firm based in Torrance, California, will supply at-home blood collection kits. Researchers will ship each study participant a MitraHome Blood Collection Kit and provide detailed instructions on collecting a microsample of blood and mailing it back for future analysis in the laboratory.

The study will be conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), with additional support from the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI), all parts of NIH.

People interested in joining this study should contact clinicalstudiesunit@nih.gov.