Study registration: *
Publication Tenforde M, Clin Infect Dis, 2021
Dates: 2020-12-14 to 2021-05-05
Funding: Public/non profit (US Centers for Disease Control and Prevention; National Center for Advancing Translational Sciences )
Conflict of interest: Yes (S. M. B. reports grants from CDC during the conduct of the study; personal fees for chairing a data and safety monitoring board (DSMB) for a trial in respiratory failure from Hamilton, money paid to institution for their service on a trial steering committee from Faron, grants and money paid to institution for their service on a trial steering committee from Sedana, grants from Janssen, grants from National Institutes of Health (NIH), grants from Department of Defense (DoD), book royalties from Oxford University, book royalties from Brigham Young University, and personal fees for service on a DSMB from New York University, outside the submitted work. J. D. C. reports grants from the NIH (K23HL153584), outside the submitted work. S. Y. C. was a speaker for La Jolla Pharmaceuticals in 2018, and consulted for PureTech Health in 2020. J. D. C. reports grants from the CDC, grants from National Center for Advancing Translational Science/NIH during the conduct of the study. M. C. E. reports sponsored talks on nutrition in coronavirus disease (COVID) pneumonia at ASPEN conference for Abbott Labs, out- side the submitted work. D. C. F. reports personal fees as consultant from Cytovale, DSMB member from Medpace, outside the submitted work. M. G. reports grants from CDC-Vanderbilt (IVY3 subcontract study), during the conduct of the study; grants from CDC (HAIVEN–COVID VE [Adult Inpatient] and Ambulatory US Flu VE Network), grants from CDC-Abt (RECOVER COVID VE in HCP and FW), grants from CDC-Westat (VISION COVID VE, EMR based), outside the submitted work. H. B. G. reports personal fees for serving on advisory board for COVID treatments from Gilead Sciences, Inc, outside the submitted work. A. A. G. re- ports grants from the CDC, during the conduct of the study; grants from AbbVie, grants from Faron Pharmaceuticals, outside the submitted work. M. N. G. reports grants from the CDC, during the conduct of the study; grants from the NIH, grants from the Agency for Healthcare Research and Quality, fees for participating on DSMB not related to this work from Regeneron, personal fees from Philips Healthcare for participation on scientific advisory panel not related to this work, outside the sub- mitted work. C. G. G. reports consultantship from Pfizer, consultantship from Merck, consultantship from Sanofi-Pasteur, grants from Campbell Alliance/Syneos Health, grants from the CDC, grants from NIH, grants from Food and Drug Administration, grants from Agency for Health Care Research and Quality, grants from Sanofi, outside the submitted work. D. N. H. reports other from the CDC via subcontract with Vanderbilt (contract for patient recruitment and data collection) during the con- duct of the study; per-patient compensation to enroll subjects in the RUXCOVID-DEVENT Trial from Incyte Corporation, salary support for conduct of VICTAS Trial from Marcus Foundation, salary support for participation in EMPACT Network from EMPACT Precision Medicine via Vanderbilt University Medical Center, outside the submitted work. N. H. reports grants from the CDC during the conduct of the study; grants and nonfinancial support from Sanofi for HAI and MN testing, grants from Quidel outside the submitted work. A. K. reports grants from United Therapeutics, grants from Johnson & Johnson, grants from 4D Medical, grants from Lung LLC, grants from Reata Pharmaceuticals, outside the submitted work. J. H. K. reports grants from the CDC, during the con- duct of the study. A. S. L. reports personal fees for serving as consultant on antiviral drugs from Sanofi, personal fees from Roche (Paid member of trial steering committee), outside the submitted work. C. J. L. reports grants from the CDC, during the conduct of the study; grants from NIH, grants from DoD, grants from Marcus Foundation, contracts to organization from bioMerieux, contracts to organization from Endpoint LLC, contracts to organization from Entegrion Inc, outside the submitted work; in addition, C. J. L. has a patent for risk stratification in sepsis and septic shock issued to Cincinnati Children’s Hospital Medical Center. E. T. M. reports grants from Vanderbilt University/CDC, during the conduct of the study; personal fees from Pfizer for unrelated work, grants from Merck for unrelated work, outside the submitted work. A. S. M. reports consulting fees from Sanofi-Pasteur and Seqirus outside the submitted work. I. D. P. reports grants from CDC, during the conduct of the study; grants from National Institutes of Health, grants from Janssen Pharmaceuticals, payment to institution for trial enrollments from Asahi Kasei Pharma, payment to institution for trial enrollments from Regeneron, outside the submitted work. T. W. R. reports grants from the CDC (IVY Network), during the conduct of the study; personal fees for serving as Director of Medical Affairs from Cumberland Pharmaceuticals, Inc, personal fees for consulting from Avisa Pharma, LLC, personal fees for serving as DSMB member from Sanofi, outside the submitted work. W. S. H. reported re- search funding from the CDC for the current project and consulting fees outside the submitted work from Aerpio Pharmaceuticals and Merck; W. S. H. also reports receiving research funding and consultant fees from Merck related to pneumococcal vaccine work and receiving consultant fees from Aerpio Pharmaceuticals related to development of an acute respiratory distress syndrome small molecule drug, outside the submitted work. All other authors report no potential conflicts. )
Methods | |
Study design:Test-negative Description of participants: Hospitalized adults at 18 centers in the USA. Inclusion criteria:
Exclusion criteria:
Follow-up duration (months): 4.73 | |
Vaccines: |
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Variant description : |
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Variant name: Alpha Evidence: Direct evidence (effectiveness determined by sequencing cases) | |
Documents available |
Protocol NR Statistical plan No Data-sharing stated:
NR |
General comment | Concerns about uncontrolled confounding; factors such as socio-economic status and comorbidities were not adjusted for. |