Lessons Learned from National Heart, Lung, and Blood Institute Covid-19 Clinical Trials
AbstractIn response to the Covid-19 pandemic, the National Heart, Lung, and Blood Institute launched five multisite clinical trials testing candidate host tissue-directed medical interventions to hasten recovery, improve function, and reduce morbidity and mortality. Speed, flexibility, and collaboration were essential. This article from the Steering and Executive committees describes the Collaborating Network of Networks for Evaluating Covid-19 and Therapeutic Strategies (CONNECTS) research program that enrolled 6690 participants and evaluated 18 intervention strategies using 10 molecular agents across the care continuum (outpatient, inpatient, and post discharge), and reports lessons learned from this initiative. Successes include rapid trial execution through collaboration and adaptive platform designs. Challenges that impeded efficiency included time required to execute subcontracts, constraints on clinical research workforce, and limited research infrastructure in nonacademic settings.
Authors
- Nigel S. Key (ORCID: https://orcid.org/0000-0002-8930-4304)
- Diane J. Nugent (ORCID: https://orcid.org/0000-0002-1109-0879)
- Mary Cushman (ORCID: https://orcid.org/0000-0002-7871-6143)
- Lisa M. LaVange (ORCID: https://orcid.org/0000-0001-6755-6925)
- Clifton W. Callaway (ORCID: https://orcid.org/0000-0002-3309-1573)
- Adit A. Ginde (ORCID: https://orcid.org/0000-0003-2325-206X)
- David C. Goff (ORCID: https://orcid.org/0000-0001-7988-8361)
- Clyde W. Yancy (ORCID: https://orcid.org/0000-0001-7271-4166)
- Tracy L. Nolen (ORCID: https://orcid.org/0000-0003-2512-343X)
- Sonia Thomas (ORCID: https://orcid.org/0000-0003-1362-5627)
- Gordon R. Bernard (ORCID: https://orcid.org/0000-0002-4721-3068)
- Sean P. Collins (ORCID: https://orcid.org/0000-0002-2305-9836)
- Robert A. Harrington (ORCID: https://orcid.org/0000-0001-5450-8676)
- Stephen R. Wisniewski (ORCID: https://orcid.org/0000-0002-3877-9860)
- Mark W. Geraci (ORCID: https://orcid.org/0000-0002-2280-3424)
- Kelsey N. Womack (ORCID: https://orcid.org/0000-0002-4628-8615)
- Thomas L. Ortel (ORCID: https://orcid.org/0000-0001-6193-4585)
- Antonello Punturieri
- Jerry A. Krishnan (ORCID: https://orcid.org/0000-0001-5525-4778)
- Annetine C. Gelijns (ORCID: https://orcid.org/0000-0001-5389-953X)
- Samuel Morris Brown (ORCID: https://orcid.org/0000-0003-1206-6261)
- Judith S. Hochman (ORCID: https://orcid.org/0000-0002-5889-5981)
- Paul M. Ridker (ORCID: https://orcid.org/0000-0003-1249-4522)
- Lisa G. Berdan
- Amy P. Patterson
- Serpil Erzurum
Institutions
- Intermountain Healthcare (US)
- University of Vermont (US)
- Northwestern University (US)
- University of North Carolina at Chapel Hill (US)
- Brigham and Women's Hospital (US)
- Children's Hospital of Orange County (US)
- Cleveland Clinic (US)
- University of Pittsburgh (US)
- Duke University (US)
- RTI International (US)
- Cornell University (US)
- University of Utah (US)
- University of Illinois Chicago (US)
- VA Tennessee Valley Healthcare System (US)
- National Heart, Lung, and Blood Institute (US)
- Geriatric Research Education and Clinical Center (US)
- Weill Cornell Medicine (US)
- New York University (US)
- Vanderbilt University Medical Center (US)
- University of Colorado Denver (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- NEJM Evidence
- Published
- 2024-10-22
- DOI
- https://doi.org/10.1056/evidctcs2300291
- Citations
- 1
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 1.13
Funders
- U.S. Department of Health and Human Services
- Vanderbilt University
- RTI International
- Vanderbilt University Medical Center
- Australian Government
- National Institutes of Health
- National Heart, Lung, and Blood Institute