COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection. Comprehensive Datasets
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2020-12-30
2022-11-27
2022-11-27
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Six sites in the United States
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Bramante, Carolyn
covidout@umn.edu
covidout@umn.edu
Abstract
The COVID-OUT clinical trial was a decentralized, randomized, placebo controlled clinical trial of early outpatient treatment of SARS-CoV-2 infection. The trial used a 2x3 factorial design to test metformin versus placebo, ivermectin versus placebo, and fluvoxamine versus placebo.
Description
This is the data for the COVID-OUT clinical trial.
1) "Covid_Out_Primary_DRUM.csv" - This database includes all the data needed to replicate the analyses in the acute outcomes paper (PMC9945922) and the long-term outcomes paper (PMC11259948). The code used for analyzing the data in the papers is in the data dictionary file.
2) "covid_out_viral_load_data.csv" - This database includes all the data needed to replicate the analyses in the viral load outcomes paper (PMC11327787). The code used for analyzing the data in the papers is in the data dictionary file.
Referenced by
1) Acute outcomes paper: Bramante, C. T., Huling, J. D., Tignanelli, C. J., Buse, J. B., Liebovitz, D. M., Nicklas, J. M., ... & Murray, T. A. (2022). Randomized trial of metformin, ivermectin, and fluvoxamine for Covid-19. New England Journal of Medicine, 387(7), 599-610. https://doi.org/10.1056/NEJMoa2201662
2) Long term outcomes paper: Bramante, C. T., Buse, J. B., Liebovitz, D. M., Nicklas, J. M., Puskarich, M. A., Cohen, K., ... & Zinkl, L. (2023). Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial. The Lancet Infectious Diseases, 23(10), 1119-1129. https://doi.org/10.1016/S1473-3099(23)00299-2
3) Viral Load Outcomes paper: Bramante, C. T., Beckman, K. B., Mehta, T., Karger, A. B., Odde, D. J., Tignanelli, C. J., ... & Huling, J. D. (2024). Favorable antiviral effect of metformin on SARS-CoV-2 viral load in a randomized, placebo-controlled clinical trial of COVID-19. Clinical Infectious Diseases, 79(2), 354-363. https://doi.org/10.1093/cid/ciae159
2) Long term outcomes paper: Bramante, C. T., Buse, J. B., Liebovitz, D. M., Nicklas, J. M., Puskarich, M. A., Cohen, K., ... & Zinkl, L. (2023). Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial. The Lancet Infectious Diseases, 23(10), 1119-1129. https://doi.org/10.1016/S1473-3099(23)00299-2
3) Viral Load Outcomes paper: Bramante, C. T., Beckman, K. B., Mehta, T., Karger, A. B., Odde, D. J., Tignanelli, C. J., ... & Huling, J. D. (2024). Favorable antiviral effect of metformin on SARS-CoV-2 viral load in a randomized, placebo-controlled clinical trial of COVID-19. Clinical Infectious Diseases, 79(2), 354-363. https://doi.org/10.1093/cid/ciae159
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Supported by the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants, and UnitedHealth Group Foundation.
The fluvoxamine placebo tablets were donated by Apotex Pharmaceuticals.
The ivermectin placebo and active tablets were donated by Edenbridge Pharmaceuticals.
Dr. Bramante was supported by grants (KL2TR002492 and UL1TR002494) from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) and by a grant (K23 DK124654–01-A1) from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH.
Dr. Buse was supported by a grant (UL1TR002489) from NCATS.
Dr. Nicklas was supported by a grant (K23HL133604) from the National Heart, Lung, and Blood Institute of the NIH.
Dr. Odde was supported by the Institute for Engineering in Medicine, the Medtronic Professorship for Engineering in Medicine, and by grants (U54 CA210190 and P01 CA254849) from the National Cancer Institute of the NIH.
The fluvoxamine placebo tablets were donated by Apotex Pharmaceuticals.
The ivermectin placebo and active tablets were donated by Edenbridge Pharmaceuticals.
Dr. Bramante was supported by grants (KL2TR002492 and UL1TR002494) from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) and by a grant (K23 DK124654–01-A1) from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH.
Dr. Buse was supported by a grant (UL1TR002489) from NCATS.
Dr. Nicklas was supported by a grant (K23HL133604) from the National Heart, Lung, and Blood Institute of the NIH.
Dr. Odde was supported by the Institute for Engineering in Medicine, the Medtronic Professorship for Engineering in Medicine, and by grants (U54 CA210190 and P01 CA254849) from the National Cancer Institute of the NIH.
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Bramante, Carolyn. (2025). COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection. Comprehensive Datasets. Retrieved from the Data Repository for the University of Minnesota (DRUM), https://hdl.handle.net/11299/269790.
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