Table 1 Summary of Clinical Studies on Fluvoxamine Included in the Systematic Review and Meta-Analysis. This table provides detailed information on all the clinical studies using fluvoxamine that were included in the systematic review and meta-analysis.
Population | Study type | Dates | Intervention | Participants | Controls | Clinical deterioration | Death | |
|---|---|---|---|---|---|---|---|---|
STOP COVID Lenze et al | Adults with COVID 19 confirmed by PCR | Randomized placebo controlled | April 10, 2020, to August 5, 2020 | 100 mg of fluvoxamine or placebo 3 times daily for 15 days | 80 | 72 | Fluvoxamine 0/80 (0%) Control 6/72 (8.3%) | Fluvoxamine 0/80 (0%) Control 0 /72 (0%) |
STOP COVID 2 Reiersen et al | Unvaccinated adults (30 + years) with COVID 19 confirmed by PCR | Randomized placebo controlled | December 22, 2020, to May 21, 2021 | 100 mg fluvoxamine or placebo twice daily for 15 days | 272 | 275 | Fluvoxamine 13/272 (4.8%) Control 15/275 (5.5%) | Fluvoxamine 0/272 (0%) Control 0/275 (%) |
TOGETHER Reis et al | Adults with COVID 19 confirmed by PCR | Randomized placebo controlled | January 20, to August 5, 2021 | 100 mg fluvoxamine or placebo twice daily | 741 | 756 | Fluvoxamine 79/741 (11%) Control 119/756 (16%) | Fluvoxamine 1/548(0.2%) Control 12/618 (2%) |
Covid OUT Bramante et al | Adults (30–85 years) with COVID 19 confirmed by PCR | Randomized placebo controlled | December 30, 2020, to February 14, 2022 | 50 mg fluvoxamine or placebo twice daily for 14 days | 156 | 291 | Fluvoxamine 15/156 (9.6%) Control 48/291 (16.5%) | Fluvoxamine 0/156 (0%) Control 0/291 (0%) |
ACTIV-6 Arm B McCarthy et al | Adults with COVID 19 confirmed by PCR experiencing 2 or more symptoms of acute COVID-19 for 7 days or less | Randomized placebo controlled | August 6, 2021, to May 27, 2022, | 50 mg fluvoxamine or placebo twice daily for 10 days | 646 | 588 | Fluvoxamine 27/646 (4.2%) Control 26/588 (4.4%) | Fluvoxamine 0/646 (0%) Control 0/588 (0%) |
ACTIV-6 ARM E Stewart et al | Adults (30 + years) with COVID 19 confirmed by PCR experiencing 2 or more symptoms of acute COVID-19 for 7 days or less | Randomized placebo controlled | August 25, 2022, and January 20, 2023 | 100 mg of fluvoxamine or placebo twice daily for 13 days | 589 | 586 | Fluvoxamine 14/589 (2.3%) Control 21/586 (3.6%) | Fluvoxamine 0/589 (0%) Control 0/586 (0%) |
Soe et al | Adults (18 + years) with COVID 19 confirmed by PCR | Randomized placebo controlled | January 15, 2021, to February 19, 2021 | 100 mg of fluvoxamine or placebo twice daily for 10 days | 26 | 26 | Fluvoxamine 2/26 (7.6%) Control 2/26 (7.6%) | N/A |
Calusic et al | Adults (18 + years) with COVID 19 confirmed by PCR | Open-label, prospective cohort trial with matched controls | April 1, to May 31, 2021 | 100 mg three times daily | 51 | 51 | Fluvoxamine 30/51 (58.8%) Control 39/51 (76.5%) | Fluvoxamine 30/51(58.8%) Control 39/51(76.5%) |
Pineda et al | Patients (15 + years) COVID 19 confirmed by PCR or antigen test kit | Prospective observational real-world study | November 1, 2020 toJanuary 31, 2022 | 100 mg two or three times a day (tolerance depending) | 594 | 63 | Fluvoxamine 30/594 (5%) Control 10/63 (16%) | Fluvoxamine 1/594 (0.2%) Control 4/63 (6.3%) |
Seftel et al | Adults with COVID 19 confirmed by PCR | Prospective cohort observational real-word study | November 1, to December 31, 2020 | 50 mg twice daily for 14 days | 65 | 48 | Fluvoxamine 0/65 (0%) Control 6/48 (12.5%) | Fluvoxamine 0/65 (0%) Control 1/48 (2.1%) |
Kirenga et al | Adults with COVID 19 confirmed by PCR | prospective interventional open-label cohort study | December 1, 2021 to February 28, 2022 | 100 mg twice a day for 10 days | 94 | 222 | Fluvoxamine 43/94 (45.7%) Control 153/222 (68.9%) | Fluvoxamine 29/94 (30.9%) Control 126 /222 (56.8%) |
Wannigama et al | Adults (18–60 years) with COVID 19 confirmed by PCR | open-label, multi-arm, randomized controlled trial | October 1, 2021, to September 21, 2022 | 100–150 mg over 14 days | 132 | 366 | Fluvoxamine + standard care 9/163 (5.5%) Control 42/366 (11.5%) | Fluvoxamine + standard care 0/162 (0%) Control 0/336 (0%) |
Siripongboonsitti et al | Adults (18 + years) with COVID 19 confirmed by PCR | Open-label randomized controlled trial | June 26, 2021, to February 22, 2022 | 50 mg Fluvoxamine 2 times per day + favipiravir | 132 | 134 | Fluvoxamine 4/132 (3%) Control 0/134 (0%) | N/A |
Tsiakalos et al | Adults with COVID 19 confirmed by PCR | Real-World, Retrospective, before–after Analysis | September 2021 and December 2021 | 100 mg fluvoxamine 2 tmes daily | 53 | 50 | Fluvoxamine 2/53 (3.8%) Control 8/50 (16%) | Fluvoxamine 0/53 (0%) Control 0/50 (0%) |
Oskotsky et al | Adults COVID 19 confirmed by PCR or laboratory antigen test kit | Retrospective cohort study | January to September 2020 | N/A | 481 | 7215 | N/A | Fluvoxamine/fluoxetine 48/481 (10.0%) Control 956/7215 (13.3%) |
