NCATS’ Clinical and Translational Science Awards (CTSA) Program brings together academic medical centers from around the country to innovate locally, regionally and nationally on the myriad scientific and operational roadblocks currently limiting clinical translation. Having an established collaborative structure in place to enhance operational and scientific efficiency as well as safety has been critical to launching clinical studies quickly during the COVID‑19 pandemic.
- Engaging Collaborative Networks in Clinical Trials for COVID‑19 Treatments
- Expanding Enrollment for Clinical Trial Testing Convalescent Plasma as Therapy for COVID‑19
- Leveraging Established Partnerships Accelerates Startup of Early COVID‑19 Studies
- Illuminating the Body’s Response to SARS-CoV-2 Infection
Engaging Collaborative Networks in Clinical Trials for COVID‑19 Treatments
Running multisite clinical trials is complicated, expensive and time-consuming. NCATS is making the process more efficient for two adaptive Phase 3 clinical trials by leveraging the existing clinical research infrastructure and collaborative networks of its CTSA Program. Both trials are part of the Accelerating COVID 19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. They seek to evaluate the safety and efficacy of drugs to treat COVID‑19 but focus on different approaches and levels of disease severity.
- The ACTIV-1 trial is testing three immune modulator drugs to determine if they can restore balance to an overactive immune system and, as a result, reduce the need for ventilators and shorten hospital stays in hospitalized adults with COVID‑19. The CTSA Program — with its extensive capacity and broad geographical reach — has played a key role in adding U.S. study sites and enrolling patients, including those from communities disproportionately affected by COVID‑19.
Learn more about the ACTIV-1 trial, which launched in October 2020.
- The ACTIV-6 trial will test several existing drugs — an approach called drug repurposing — to see if they can provide safe, effective symptom relief and prevent hospitalization in people with mild to moderate COVID‑19. Two CTSA Program hubs will serve as coordinating centers and partner with the Patient-Centered Outcomes Research Institute to expedite enrollment. ACTIV-6 is currently enrolling participants to test the safety and effectiveness of Ivermectin in treating mild to moderate COVID-19 symptoms at home.
Learn more about the ACTIV-6 trial, which was announced in May 2021.
Expanding Enrollment for Clinical Trial Testing Convalescent Plasma as Therapy for COVID‑19
Rigorous clinical trials can deliver strong evidence on whether COVID‑19 treatments are safe and effective. The CTSA Program, including its Trial Innovation Network (TIN), played a key role in rapidly expanding enrollment in two randomized, placebo-controlled trials evaluating convalescent plasma as a treatment for people hospitalized with COVID‑19. The trials demonstrated a nimble and coordinated response to the nation’s public health need to bring safe, effective COVID‑19 therapies to patients sooner.
Read more about these clinical trials, which launched in September 2020.
Leveraging Established Partnerships Accelerates Startup of Early COVID‑19 Studies
As the COVID‑19 pandemic rapidly emerged, NCATS’ CTSA Program stepped up to ensure effective support and rapid implementation of clinical research studies aimed at treating and understanding various aspects of COVID‑19. For example, in March 2020, a CTSA Program collaboration between the Indiana Clinical and Translational Sciences Institute (CTSI) and the South Carolina Clinical & Translational Research (SCTR) Institute resulted in a study to determine if health care providers at a hospital have been exposed to the virus that causes COVID‑19. The SCTR launched a fast-track approval process, refined the protocol and implemented the study within 15 days.
Read more about the collaboration.
Illuminating the Body’s Response to SARS-CoV-2 Infection
Understanding how the immune system responds to SARS-CoV-2, the virus that causes COVID‑19, could allow clinicians to use the patient’s stage of infection to inform treatment selections and better tailor patient therapies. CTSA Program–funded scientists in Colorado mapped how the human immune system shifts its approach over the course of infection by SARS-CoV-2. Led by scientists at the University of Colorado Anschutz Medical Campus, Aurora, the research team examined the immune system’s molecular mechanisms in response to SARS-CoV-2 infection. In a study published in March 2021, they tracked the body’s response to infection in hospitalized COVID‑19 patients. The researchers analyzed which immune system cells were more prevalent or less prevalent during each stage of infection. The resulting biosignature data could be used to help determine the optimal treatment approach for patients hospitalized with COVID‑19.
Read more about this research.
Learn more about NCATS’ translational approach to addressing COVID‑19: