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
- Innovative Clinical Trials Are Delivering Answers on Convalescent Plasma’s Effectiveness as a COVID-19 Therapy
- Leveraging Established Partnerships Accelerates Startup of Early COVID‑19 Studies
- Illuminating the Body’s Response to SARS-CoV-2 Infection
- Sharing Best Practices and Lessons Learned for Addressing COVID-19 in Research
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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 clinical trial tested three immune modulator drugs that help minimize the effects of an overactive immune response to determine if they could speed recovery and reduce deaths in adults hospitalized with moderate to severe COVID-19. Researchers found that two of the three drugs, infliximab and abatacept, substantially improved clinical status and reduced deaths, although they did not significantly shorten time to recovery. The CTSA Program — with its extensive capacity and broad geographical reach — played a key role in adding U.S. study sites and enrolling patients. Preprints for abatacept and infliximab are available.
Learn more about the preliminary results from the ACTIV-1 trial, which launched in October 2020.
The ACTIV-6 trial is testing 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 serve as coordinating centers and partner with the Patient-Centered Outcomes Research Institute to expedite enrollment. ACTIV-6 is testing the safety and effectiveness of several drugs, including ivermectin, fluvoxamine and fluticasone, in treating mild to moderate COVID-19 symptoms at home. Results of the ACTIV-6 clinical trial are available. Read the ivermectin 400, ivermectin 600 and fluvoxamine peer-reviewed publications and the preprint for fluticasone.
Learn more about the ACTIV-6 trial, which was announced in May 2021.
Innovative Clinical Trials Are Delivering Answers on Convalescent Plasma’s Effectiveness as a COVID-19 Therapy
The CTSA Program is playing a key role in clinical trials that aim to determine if convalescent plasma is a viable therapy for COVID-19. CTSA Program hubs rapidly expanded enrollment and accelerated data analysis in two randomized, placebo-controlled trials, CONTAIN COVID-19 and PassItOn, evaluating convalescent plasma as a treatment for people hospitalized with COVID-19. These studies demonstrate a nimble and coordinated response to bring safe, effective COVID-19 therapies to patients sooner.
Read more about the CONTAIN COVID-19 and PassItOn clinical trials, which launched in September 2020.
The CONTAIN COVID-19 trial showed that for people hospitalized with COVID-19, convalescent plasma taken from those who had recovered was not more effective than placebo in delivering clinical improvement 14 days and 28 days after treatment began. Read a statement about the results published in January 2022.
Results from PassItOn showed that among adults hospitalized with COVID-19, participants who received convalescent plasma had nearly identical clinical outcomes as participants who received the placebo at 28 days following treatment. Read the results of the trial published in June 2022.
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.
Sharing Best Practices and Lessons Learned for Addressing COVID-19 in Research
The Journal of Clinical and Translational Science published a special issue in June 2021 titled “Re-engineering the Clinical Research Enterprise in Response to COVID-19: The CTSA Experience,” which explores the many ways the CTSA Program pivoted to address COVID-19. The articles in this issue touch on many of the program focus areas and illuminate how the supported hubs enhance translation and catalyze innovation. COVID-19 created a new clinical and translational research landscape, and the efforts highlighted in this journal issue demonstrate how researchers can continue to address COVID-19 and future public health emergencies.
Read more about this special issue.
Learn more about NCATS’ translational approach to addressing COVID‑19: