Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study)
Objectives: Fluvoxamine (FVX) is an antidepressant proposed to its immunomodulatory effects in preventing deterioration in mild and moderate COVID-19. Methods: An open-label, 1:1 randomized controlled trial was assigned either combination therapy 50 mg twice daily of FVX for 10 days and favipiravir...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-09-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223006410 |
| _version_ | 1797752983996334080 |
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| author | Taweegrit Siripongboonsitti Teerapat Ungtrakul Kriangkrai Tawinprai Tararin Nimmol Mullika Buttakosa Gaidganok Sornsamdang Tanadul Jarrusrojwuttikul Phumin Silapant Nithi Mahanonda |
| author_facet | Taweegrit Siripongboonsitti Teerapat Ungtrakul Kriangkrai Tawinprai Tararin Nimmol Mullika Buttakosa Gaidganok Sornsamdang Tanadul Jarrusrojwuttikul Phumin Silapant Nithi Mahanonda |
| author_sort | Taweegrit Siripongboonsitti |
| collection | DOAJ |
| description | Objectives: Fluvoxamine (FVX) is an antidepressant proposed to its immunomodulatory effects in preventing deterioration in mild and moderate COVID-19. Methods: An open-label, 1:1 randomized controlled trial was assigned either combination therapy 50 mg twice daily of FVX for 10 days and favipiravir (FPV) or FPV alone to assess the efficacy in preventing disease progression in mild to moderate COVID-19 on the 5th day. Results: In total, 134 patients with mild COVID-19 received FPV and 132 received FVX/FPV, 31 patients with moderate COVID-19 received FPV/dexamethasone (FPV/Dex), and 30 received FVX/FPV/Dex. The intention-to-treat (ITT) analysis showed no difference of no clinical deterioration on the 5th day in both mild COVID-19 (100% in FPV vs 97% in FVX/FPV) and moderate COVID-19 (83.9% in FPV/Dex vs 86.7% in FVX/FPV/Dex). However, there was a low rate of oxygen supplemental, hospitalization, or intensive care in both groups and zero death in all groups. No significant difference in oxygen supplemental, hospitalization, radiological, virological, or biochemical outcomes, and the immunomodulatory effect was observed between the group. Conclusion: The combined fluvoxamine treatment did not add benefit in preventing deterioration in patients with mild to moderate COVID-19 without the immunomodulatory effect observed, although it demonstrated low hospitalization rates, oxygen supplemental, intensive care needed, and zero mortality. Trial Registration: Thai clinical trials registry (TCTR) no. 20210615002. |
| first_indexed | 2024-03-12T17:12:25Z |
| format | Article |
| id | doaj.art-7ea8cdad9a994bf7b265475b19f6c888 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-12T17:12:25Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-7ea8cdad9a994bf7b265475b19f6c8882023-08-06T04:36:45ZengElsevierInternational Journal of Infectious Diseases1201-97122023-09-01134211219Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study)Taweegrit Siripongboonsitti0Teerapat Ungtrakul1Kriangkrai Tawinprai2Tararin Nimmol3Mullika Buttakosa4Gaidganok Sornsamdang5Tanadul Jarrusrojwuttikul6Phumin Silapant7Nithi Mahanonda8Division of Infectious Diseases, Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand; Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand; Corresponding author: Tel: +66816924872.Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, ThailandDivision of Infectious Diseases, Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, ThailandPharmacy Department, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, ThailandNursing Department, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, ThailandCentral Laboratory Center, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, ThailandFaculty of Health Science Technology, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand; Department of Radiology, Queen Savang Vadhana Memorial Hospital, Chonburi, ThailandChulabhorn Royal Academy, Bangkok, ThailandChulabhorn Royal Academy, Bangkok, ThailandObjectives: Fluvoxamine (FVX) is an antidepressant proposed to its immunomodulatory effects in preventing deterioration in mild and moderate COVID-19. Methods: An open-label, 1:1 randomized controlled trial was assigned either combination therapy 50 mg twice daily of FVX for 10 days and favipiravir (FPV) or FPV alone to assess the efficacy in preventing disease progression in mild to moderate COVID-19 on the 5th day. Results: In total, 134 patients with mild COVID-19 received FPV and 132 received FVX/FPV, 31 patients with moderate COVID-19 received FPV/dexamethasone (FPV/Dex), and 30 received FVX/FPV/Dex. The intention-to-treat (ITT) analysis showed no difference of no clinical deterioration on the 5th day in both mild COVID-19 (100% in FPV vs 97% in FVX/FPV) and moderate COVID-19 (83.9% in FPV/Dex vs 86.7% in FVX/FPV/Dex). However, there was a low rate of oxygen supplemental, hospitalization, or intensive care in both groups and zero death in all groups. No significant difference in oxygen supplemental, hospitalization, radiological, virological, or biochemical outcomes, and the immunomodulatory effect was observed between the group. Conclusion: The combined fluvoxamine treatment did not add benefit in preventing deterioration in patients with mild to moderate COVID-19 without the immunomodulatory effect observed, although it demonstrated low hospitalization rates, oxygen supplemental, intensive care needed, and zero mortality. Trial Registration: Thai clinical trials registry (TCTR) no. 20210615002.http://www.sciencedirect.com/science/article/pii/S1201971223006410FluvoxamineFavipiravirCOVID-19SARS-CoV-2SSRI |
| spellingShingle | Taweegrit Siripongboonsitti Teerapat Ungtrakul Kriangkrai Tawinprai Tararin Nimmol Mullika Buttakosa Gaidganok Sornsamdang Tanadul Jarrusrojwuttikul Phumin Silapant Nithi Mahanonda Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) International Journal of Infectious Diseases Fluvoxamine Favipiravir COVID-19 SARS-CoV-2 SSRI |
| title | Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) |
| title_full | Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) |
| title_fullStr | Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) |
| title_full_unstemmed | Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) |
| title_short | Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study) |
| title_sort | efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe covid 19 among mild to moderate covid 19 patients open label randomized controlled trial effaco study |
| topic | Fluvoxamine Favipiravir COVID-19 SARS-CoV-2 SSRI |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223006410 |
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