The global COVID-19 pandemic has proved disastrous for the world’s health and economies. Millions of people have been infected. More than a million people have died. And millions more are out of work as economies stumbled and fell. In the U.S., the Centers for Disease Control and Prevention (CDC) plays a critical role in combatting the pandemic and conducting research. CDC’s real-time surveillance of COVID-19 cases and analyses of surveillance data inform public health policies, communication about protective behaviors, and guidance to public health and healthcare providers, communities, businesses, and schools.
To carry out its responsibilities, CDC urgently requires research data to further inform the COVID-19 response, especially related to risk and protective factors across key population groups. They include healthcare personnel, first responders, and essential workers; pregnant women and infants; individuals 50 years and older; older adults in continuing care retirement communities; and households.
Abt is supporting a variety of CDC COVID-19 research initiatives. Since 2013 under a contract with CDC, Abt has managed an infrastructure of clinical health organizations set up to conduct network studies to assess risk and characterize disease epidemiology of novel influenza or other novel respiratory viruses among different population cohorts. Abt recognized that it could pivot and use this infrastructure to perform these tasks for COVID-19. Abt has significant experience with the approaches needed to provide the studies and data CDC requires. They include:
Data collection and coordination
Data management, cleaning, and analytic file preparation
Specimen collection, processing, and testing
Technical assistance and training
Studying cohorts with different characteristics and vulnerabilities is critical to understanding how an infectious disease spreads and affects the body. It’s especially important for monitoring vaccine safety and effectiveness. Our infectious disease and clinical research experts are leading prospective COVID-19 cohort studies with CDC and partners to assess:
transmissibility of infection
rates of infection and illness
clinical epidemiology of the disease
characteristics of medically and non-medically attended cases.
The RECOVER study is a prospective, longitudinal cohort study of approximately 3,000 healthcare personnel, first responders, and essential workers from six U.S. geographies. This research will offer CDC timely information on COVID-19 illness characterization and correlates of protection in this highly-exposed cohort. The research will also provide rates of asymptomatic infection and re-infection as well as details on viral shedding. Since this population will be prioritized for vaccination with novel COVID-19 vaccine products, this study will also accommodate an evaluation of the effectiveness of a vaccine, once it is available.
Pregnant women may be more vulnerable to respiratory infections and severe respiratory complications, and more research is needed on potential effects of these on birth outcomes. ESPI is using an existing network of sites and protocols from the CDC Pandemic Flu and Global Flu contracts to conduct two separate cohort studies among pregnant women. Findings from this study will provide timely information for CDC on the risk factors for infection and characteristics of COVID-19 illness and complications, as well as the effects of infection on pregnancy and infant outcomes. A better understanding of this burden may help inform future public health policy regarding pregnant women, young infants, and COVID-19.
Older adults in particular are considered a high-risk group for contracting novel coronavirus and for developing severe illness if infected. This study will consist of two activities:
an electronic cohort that monitors and describes medical care for hospitalized patients in a rural health care system aged ≥50 years old based on electronic medical record extraction.
prospective enrollment and follow-up of a subset of test-positive study participants and matched test-negative controls who were admitted to inpatient care and tested for novel coronavirus.
Older adults are among those with the highest risk for medically attended COVID-19. Characterization of risk factors and clinical epidemiology of COVID-19 among older adults may inform public health strategies to prevent infection and reduce the burden of severe disease in this population. Within participating retirement communities, the CITRUS project will enroll residents from different resident groups (independent living homes and assisted living facilities). Active surveillance will capture COVID-19 cases among both symptomatic and asymptomatic participants. The primary objectives of the CITRUS cohort are to: 1) estimate the cumulative incidence of asymptomatic and symptomatic infection in community-dwelling older adults in the US; and 2) establish kinetics of immunity over time. Secondary objectives include describing illness severity, risk factors for infection, healthcare utilization, and immune response to vaccination and vaccine effectiveness when SARS-CoV-2 vaccines become available.
Household studies offer researchers a unique opportunity to capture illnesses among individuals who do not seek medical care. These studies allow for a better understanding of the true burden of disease and other characteristics of the illness. C-HEaRT adapts existing methodologies used during influenza pandemics to assess epidemiological and clinical characteristics of COVID-19. They include incidence, risk of transmission and infection, illness progression, clinical characteristics of severity, modifying behaviors, serum biomarkers, and other characteristics. Findings from this study will support CDC’s role during a pandemic for monitoring pandemic-related illness, describing the epidemiology of pandemic virus infection and the burden of disease, and monitoring and evaluating the use of public health interventions, antiviral treatment, and vaccine effectiveness.
In addition to C-HEaRT, Abt is leading data management-related activities for its sister study, SARS-CoV-2 Epidemiology And Response in Children (SEARCh), which is being led by researchers at Johns Hopkins University.
The PROTECT study is a longitudinal pediatric cohort study that evaluates COVID-19 vaccines’ real-world effectiveness in 2,300 U.S. children in four geographies. The study will provide ongoing estimates of effectiveness for COVID-19 vaccines for adolescents aged 12 to 17 years and children aged 5 to 11 years. It will include boosters or additional doses as they become available. The study also will provide a platform for studying vaccine effectiveness in children aged 6 months to 4 years should vaccines be approved for this age group. In addition, the study monitors the incidence of SARS-CoV-2 and influenza infection in this pediatric population.
Danielle Hunt, PhD, MPH
Division of Health & Environment
Abt Associates uses data and bold thinking to improve the quality of people’s lives worldwide. From increasing crop yields and combatting infectious disease, to ensuring safe drinking water and promoting access to affordable housing—and more—we partner with clients and communities to tackle their most complex challenges.