Researchers investigate the effects of high-dose fluvoxamine among patients with mild-to-moderate coronavirus disease 2019 (COVID-19).
Study
In the present study, researchers evaluate the effects of a higher dose of fluvoxamine in mild-to-moderate COVID-19 patients. Eligible subjects were aged 30 or older with a positive antigen or polymerase chain reaction (PCR) test result. Furthermore, each study participant reported experiencing at least two of the following symptoms including sore throat, loss of sense of smell/taste, body aches, diarrhea, vomiting, cough, nausea, dyspnea, fatigue, nasal symptoms, fever, and chills.
Participants were recruited from August 25, 2022, to January 20, 2023. Subjects were excluded if they participated in other COVID-19 trials, were pregnant, breastfeeding, recently/currently hospitalized for COVID-19, using fluvoxamine, or had bipolar disorder or contraindications/allergy to fluvoxamine.
Participants were instructed to consume two 50 mg tablets of fluvoxamine or placebo on the first day and 100 mg tablets of fluvoxamine or placebo twice a day for the next 12 days. Medical history, demographic information, race/ethnicity, COVID-19 symptoms, and use of other medications were self-reported by the participants.
The primary outcome was the time to sustained recovery, which was defined as the time from intervention to the third of three consecutive days without symptoms. Secondary outcomes included time to hospitalization/death, time to death, COVID-19 clinical progression scale scores, average time spent unwell, and a composite of emergency room/urgent care visits, hospitalization, or death.
Results
The study randomized 1,175 participants to receive fluvoxamine or placebo. About 66% of the study participants were female and 72.7% were White. Hypertension and obesity were the most common comorbidities.
Over 75% of participants received at least two doses of a COVID-19 vaccine. About 10% of participants reported no symptoms at the time of study drug receipt, whereas the remainder reported mild/moderate symptoms.
There were no differences in time to sustained recovery between groups, with a median of 10 days. No deaths occurred in either group. Three participants were hospitalized, including one fluvoxamine recipient.
Fourteen fluvoxamine recipients and 21 placebo recipients reported emergency room/urgent care visits or hospital admission. The clinical progression scale was simplified into a self-evaluation of home activity levels, as hospitalizations and deaths were rare.
Over 95% of study participants had no activity limitations by day seven. Moreover, the average time spent unwell was similar between groups.
Six individuals experienced serious adverse events. More specifically, two fluvoxamine recipients reported Guillain-Barre syndrome, pneumonia, and aggravated asthma, whereas four placebo recipients reported perforated intestinal diverticulitis, partial bowel obstruction, ruptured appendix, and diabetic foot ulcer.
The researchers did not observe a meaningful separation between groups when stratified by symptom severity at baseline and timing of therapy relative to symptom onset. Exploratory analyses suggested that participants who received fluvoxamine more quickly following the onset of their symptoms had poorer symptom resolution than placebo recipients. In contrast, those who received fluvoxamine treatment around seven days post-symptom onset had better resolution than placebo participants.
Conclusion
The study findings indicate that treating mild-to-moderate COVID-19 patients with a higher dose of fluvoxamine did not improve the primary outcome relative to placebo recipients. Notably, the secondary composite outcome of healthcare utilization or death suggested nearly 33% fewer events among fluvoxamine recipients; however, this effect did not meet decision-making thresholds.
Source:
https://www.news-medical.net/news/20231122/Study-finds-among-outpatients-with-mild-to-moderate-COVID-19-treatment-with-fluvoxamine-does-not-reduce-duration-of-symptoms.aspx