Abstract

Context Fluvoxamine may have a potential immune-regulatory action and a therapeutic role in severe acute respiratory syndrome-coronavirus (SARS-CoV-2) infection that may prevent progression and/or hospitalization. Aims Trial that compared fluvoxamine versus placebo in nonhospitalized adults with confirmed SARS-CoV-2 infection (mild and moderate coronavirus disease 2019 cases). Settings and design This is a double-blinded, randomized clinical trial. Patients and methods The study enrolled 162 cases with positive PCR assay for SARS-CoV-2 infection and who were symptomatic within 7 days of the first dose of study medication. Statistical analysis The demographic, clinical, and laboratory data gathered together will be tabulated and statistically analyzed. The statistical analysis of data was carried out using Excel and the SPSS programs statistical package for AQ8 Social Sciences, version 17. Quantitative data were described as median (minimum–maximum). An analysis of the data was carried out to test statistically significant differences between groups. Quantitative data were presented as mean±SD and the Student’s t test was used to compare between two groups. Results In all, 162 patients completed the study; 72 patients were of mild severity; 90 patients were moderate cases and each group was randomized to receive fluvoxamine or placebo besides standard care. In the mild group, no significant difference was recorded while slight significance exists in the moderate severity group. Conclusions Fluvoxamine may have an added value besides the current standard care in reducing the need for hospitalization in outpatient cases, especially pneumonic ones; however, more larger studies are needed.

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