In the COVID-19 pandemic, minority groups and rural communities are suffering disproportionately high infection and death rates, making inclusion of participants from these groups in studies of potential treatments and vaccines especially crucial. NCATS’ Clinical and Translational Science Awards (CTSA) Program hubs are working hand in hand with community partners on a wide range of initiatives to accelerate the discovery and delivery of COVID-19 treatments and vaccines to those in greatest need of them. The CTSA Program hubs have long prioritized engaging communities in the research process. They develop and disseminate community engagement tools and resources and work to educate researchers and communities. These efforts have made the hubs trusted community partners, allowing them to pivot rapidly to address COVID-19 health disparities. Here’s a look at how NIH and NCATS are leveraging the hubs’ vast expertise, resources and community connections to find COVID-19 answers sooner and improve health outcomes for those in communities and groups hit hardest by the COVID-19 pandemic.
- Identifying Treatments for COVID-19
When the COVID-19 pandemic began, no approved treatments or vaccines were available to counteract SARS-CoV-2. NIH responded swiftly with the ACTIV initiative, a public-private partnership to prioritize and speed the development of the most promising treatments and vaccines. The ACTIV partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19 and has prioritized the most promising candidates for rigorous clinical trials. NCATS and its CTSA Program are taking a lead role in two ACTIV trials. The first is the ACTIV-1 Immune Modulator (IM) trial, which is evaluating three therapeutics that could restore balance to an overactive immune system in adults hospitalized with COVID-19. The CTSA Program hubs are applying their expertise to speed clinical trial recruitment and expand the diversity of trial participants. Learn more about the ACTIV-1 IM trial.
The second trial is ACTIV-6, which will test several existing drugs that can be taken at home to see if the treatments provide safe, effective symptom relief in mild to moderate COVID-19 and prevent hospitalization. The CTSA Program hubs will help coordinate the trial and partner with the Patient-Centered Outcomes Research Institute to expedite enrollment. Read more about the ACTIV-6 trial.
- Improving Outcomes of the Severely Ill
Convalescent plasma from people who have recovered from COVID-19 may improve outcomes among severely ill and hospitalized patients with COVID-19. Randomized, placebo-controlled clinical trials are needed to determine if convalescent plasma truly is effective and safe. NCATS is overseeing grants that double the size of two NIH-supported randomized clinical trials to test convalescent plasma in adults hospitalized with COVID-19. Multiple CTSA Program hubs are running these vital clinical trials and expanding the trials into communities most at need during the COVID-19 pandemic. Their work demonstrates how nimbly the CTSA Program network can respond to their communities’ research and treatment needs. Learn more about how NCATS and the CTSA Program are helping to test the promise of convalescent plasma. Read more
- Understanding the Spread of the Virus
Surveying large numbers of people for the presence of antibodies to SARS-CoV-2 — called a serosurvey — is crucial to understanding the spread of the virus and how long people may remain protected after infection. NCATS scientists teamed with other NIH Institutes and the Frederick National Laboratory for Cancer Research to rapidly develop an antibody test. In addition, two CTSA Program hubs helped enroll a broad, diverse study population of about 10,000 people from the near 40,000 who volunteered to participate in the study, so the results reflected the demographics of the country. Learn more about how a translational science team of members with diverse expertise has collaborated to deliver practice-changing knowledge more quickly. Read more
- Understanding and Alleviating Barriers to COVID-19 Testing
The nation’s underserved and vulnerable populations need accurate, fast, widely accessible COVID-19 testing to safely return to normal life. To meet that need, the NIH RADx initiative is speeding the development and use of innovative COVID-19 testing technologies. RADx is exploring new uses of existing technologies and moving more advanced diagnostic technologies swiftly and safely through development and into widespread community use. The NIH RADx Underserved Populations (RADx-UP) program is funding six CTSA Program hubs to gain a better understanding of, and alleviate barriers to, COVID-19 testing and to reduce the burden of the disease among underserved and vulnerable populations. Find out how RADx is bringing COVID-19 testing options to life faster. Read more
- Raising Awareness and Educating About COVID-19
CEAL engages community partners in areas of the country where the impact of COVID‑19 has been greatest. CEAL’s goal is to reduce the burden of disease on the hardest hit communities, and the CTSA Program hubs resources are key to achieving that goal. Working directly with community partners, the hubs raise awareness about COVID-19, educate people about the pandemic, and continue to build trust and understanding. They also work to ensure that COVID-19 prevention and treatment clinical trials include racially and ethnically diverse communities most affected by the pandemic. Learn more about how CEAL, NIH and the CTSA Program hubs are working to bring COVID-19 answers to communities in need. Read more
- CTSA Supported Community Engagement Tools
The Trial Innovation Network provides resources from CTSA Program hubs and reputable community health partners conducting engagement, recruitment, and retention activities for clinical trials and multi-site studies to the research community. Types of resources include COVID-19 recruitment and retention toolkits, best practices for conducting trials during the COVID-19 pandemic, a webinar for engaging racial and ethnic minority patient populations in COVID-19 clinical trials, and more.