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Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination and Booster on Coronavirus Disease 2019 (COVID-19) Symptom Severity Over Time in the COVID-OUT Trial.
Boulware, David R; Murray, Thomas A; Proper, Jennifer L; Tignanelli, Christopher J; Buse, John B; Liebovitz, David M; Nicklas, Jacinda M; Cohen, Kenneth; Puskarich, Michael A; Belani, Hrishikesh K; Siegel, Lianne K; Klatt, Nichole R; Odde, David J; Karger, Amy B; Ingraham, Nicholas E; Hartman, Katrina M; Rao, Via; Hagen, Aubrey A; Patel, Barkha; Fenno, Sarah L; Avula, Nandini; Reddy, Neha V; Erickson, Spencer M; Lindberg, Sarah; Fricton, Regina; Lee, Samuel; Zaman, Adnin; Saveraid, Hanna G; Tordsen, Walker J; Pullen, Matthew F; Sherwood, Nancy E; Huling, Jared D; Bramante, Carolyn T.
Afiliación
  • Boulware DR; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Murray TA; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Proper JL; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Tignanelli CJ; Department of Surgery, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Buse JB; Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Liebovitz DM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
  • Nicklas JM; Department of Medicine, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
  • Cohen K; UnitedHealth Group, Optum Labs, Minnetonka, Minnesota, USA.
  • Puskarich MA; Department of Emergency Medicine, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Belani HK; Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
  • Siegel LK; Department of Medicine, Olive View - University of California, Los Angeles, California, USA.
  • Klatt NR; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Odde DJ; Department of Surgery, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Karger AB; Department of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
  • Ingraham NE; Department of Laboratory Medicine and Pathology, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Hartman KM; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Rao V; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Hagen AA; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Patel B; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Fenno SL; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Avula N; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Reddy NV; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Erickson SM; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Lindberg S; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Fricton R; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Lee S; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
  • Zaman A; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
  • Saveraid HG; Department of Medicine, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
  • Tordsen WJ; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Pullen MF; Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
  • Sherwood NE; Department of Medicine, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.
  • Huling JD; Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Bramante CT; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
Clin Infect Dis ; 76(3): e1-e9, 2023 02 08.
Article en En | MEDLINE | ID: mdl-36124697
ABSTRACT

BACKGROUND:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has decreasing protection from acquiring any infection with emergence of new variants; however, vaccination continues to protect against progression to severe coronavirus disease 2019 (COVID-19). The impact of vaccination status on symptoms over time is less clear.

METHODS:

Within a randomized trial on early outpatient COVID-19 therapy testing metformin, ivermectin, and/or fluvoxamine, participants recorded symptoms daily for 14 days. Participants were given a paper symptom diary allowing them to circle the severity of 14 symptoms as none (0), mild (1), moderate (2), or severe (3). This is a secondary analysis of clinical trial data on symptom severity over time using generalized estimating equations comparing those unvaccinated, SARS-CoV-2 vaccinated with primary vaccine series only, or vaccine-boosted.

RESULTS:

The parent clinical trial prospectively enrolled 1323 participants, of whom 1062 (80%) prospectively recorded some daily symptom data. Of these, 480 (45%) were unvaccinated, 530 (50%) were vaccinated with primary series only, and 52 (5%) vaccine-boosted. Overall symptom severity was least for the vaccine-boosted group and most severe for unvaccinated at baseline and over the 14 days (P < .001). Individual symptoms were least severe in the vaccine-boosted group including cough, chills, fever, nausea, fatigue, myalgia, headache, and diarrhea, as well as smell and taste abnormalities. Results were consistent over Delta and Omicron variant time periods.

CONCLUSIONS:

SARS-CoV-2 vaccine-boosted participants had the least severe symptoms during COVID-19, which abated the quickest over time. Clinical Trial Registration. NCT04510194.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Humans Idioma: En Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Humans Idioma: En Año: 2023 Tipo del documento: Article