The NHLBI’s Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) is an important and innovative research effort. The goal of CONNECTS is to build on NHLBI’s existing clinical research networks across the nation and around the world to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery.
Coordinating and streamlining efforts under one organizational umbrella enables us to respond quickly and efficiently by promoting standardization, collaboration, and sharing of resources and data. As part of this coordination, studies conducted under CONNECTS will use an adaptive design that will allow research to be quickly started, stopped, and adjusted as data emerges. In addition, we will leverage existing programs to expand community-based research and address the needs of at-risk populations at the community level.
Clinical trials usually test one intervention at a time within a single network of clinical trial sites. CONNECTS provides the opportunity to conduct adaptive trials across multiple networks. Researchers across these sites can test a variety of interventions simultaneously, sharing data and identifying the most—or least—promising treatments more quickly.
The CONNECTS studies will also enroll participants with health conditions, such as heart disease, high blood pressure, and chronic lung disease, that are known to increase their risk for severe complications from COVID-19.
The CONNECTS initiative provides the infrastructure to implement the NHLBI’s COVID-19 research strategy. Through the initiative, the NHLBI is building a network of networks to quickly and efficiently investigate risk factors and potential therapies for COVID-19, and to rapidly share their results to help improve patient outcomes.
The interventions tested in CONNECTS trials will focus on:
The CONNECTS initiative will also leverage process, data, and biospecimens from existing observational cohort studies. This will help establish a cohort of cohorts that will study the characteristics of people who do and do not develop SARS-CoV-2, the virus that causes COVID-19. This can help us identify risk factors, inform strategies for prevention, and suggest biomarkers of infection to improve patient outcomes.
The NHLBI will provide strategic direction, oversight, and key partnerships, in collaboration with the Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) and the federal partnership Operation Warp Speed; and other NIH Institutes and Centers, such as the National Institute of Allergy and Infectious Diseases (NIAID).
The CONNECTS initiative aims to:
A Steering Committee was established to provide oversight of the large group of networks and studies including:
A Data and Safety Monitoring Board (DSMB) monitors the safety of all CONNECTS ongoing trials.
NHLBI-CONNECTS leverages existing clinical research networks across the nation and around the world, which allows us to test treatments with a wide variety of patient populations.
Some of the networks already involved and supporting studies include Prevention and Early Treatment of Acute Lung Injury (PETAL), Recipient Epidemiology and Donor Evaluation Study (REDS), and Strategies to Innovate Emergency Care (SIREN).
CONNECTS research specimens and data will be shared on NHLBI’s Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and BioData Catalyst platforms. Shared data are identified and can be accessed by researchers.
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