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.
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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, COVID-OUT study team
Аннотация
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.