Various Combinations of Favipiravir, Lopinavir-Ritonavir, Darunavir-Ritonavir, High-Dose Oseltamivir, and Hydroxychloroquine for the Treatment of COVID-19: A Randomized Controlled Trial (FIGHT-COVID-19 Study)
et al., SSRN Electronic Journal, doi:10.2139/ssrn.3936499, NCT04303299 (history)
, Various Combinations of Favipiravir, Lopinavir-Ritonavir, Darunavir-Ritonavir, High-Dose Oseltamivir, and.., SSRN Electronic Journal, doi:10.2139/ssrn.3936499, NCT04303299
RCT 320 patients in Thailand, showing significantly lower progression with HCQ for moderate/severe patients, and faster viral clearance with mild patients (statistically significant for 800mg). There are two sets of results - for moderate/severe patients, and for mild patients. There was no mortality for mild patients. NCT04303299 (history).
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risk of death, 56.2% lower, RR 0.44, p = 0.07, treatment 7 of 100 (7.0%), control 16 of 100 (16.0%), NNT 11, moderate/severe, HCQ arms vs. non-HCQ arms.
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risk of progression, 54.2% lower, RR 0.46, p = 0.02, treatment 11 of 100 (11.0%), control 24 of 100 (24.0%), NNT 7.7, moderate/severe, HCQ arms vs. non-HCQ arms.
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time to viral-, 7.1% lower, relative time 0.93, p = 0.51, treatment mean 10.4 (±6.3) n=50, control mean 11.2 (±5.7) n=50, moderate/severe, oseltamivir arms, primary outcome.
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time to viral-, 6.9% lower, relative time 0.93, p = 0.47, treatment mean 9.5 (±5.0) n=50, control mean 10.2 (±4.6) n=50, moderate/severe, favipiravir arms, primary outcome.
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risk of progression, 150.0% higher, RR 2.50, p = 1.00, treatment 1 of 60 (1.7%), control 0 of 30 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), mild, early treatment result.
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time to viral-, 43.3% lower, relative time 0.57, p = 0.04, treatment mean 8.9 (±6.0) n=30, control mean 15.7 (±16.7) n=30, mild, HCQ 800, primary outcome, early treatment result.
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time to viral-, 36.3% lower, relative time 0.64, p = 0.09, treatment mean 10.0 (±6.9) n=30, control mean 15.7 (±16.7) n=30, mild, HCQ 400, primary outcome, early treatment result.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Atipornwanich et al., 5 Oct 2021, Randomized Controlled Trial, Thailand, peer-reviewed, 16 authors, dosage 400mg days 1-14, 800mg/day or 400mg/day, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with oseltamivir/favipiravir and duranivir/ritonavir for moderate/severe, oseltamivir and duranivir/ritonavir for mild) - results of individual treatments may vary, trial NCT04303299 (history).
Abstract: Various combinations of Favipiravir, Lopinavir-Ritonavir, Darunavir-Ritonavir,
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high-dose Oseltamivir, and Hydroxychloroquine for the treatment of Covid-19: A
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randomized controlled trial. (FIGHT-COVID-19 Study)
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Kriangsak Atipornwanich, M.D. 1,2, Subsai Kongsaengdao, M.D. 1,2, Piyathida
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Harnsomburana, M.D. 1,2, Rienthong Nanna, M.D. 3, Chatchawan Chtuparisute, M.D. 3,
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Piamlarp Saengsayan, M.D.4, Kittima Bangpattanasiri, M.D. 4, Weerawat Manosuthi, M.D.
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5,
Narumol Sawanpanyalert, M.D. 6, Attasit Srisubat, M.D. 6, Somchai Thanasithichai, M.D.
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6,
Benchalak Maneeton, M.D. 7, Narong Maneeton, M.D. 7, Chuthamanee Suthisisang, B.
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Pharm, PhD. 8, Jaturong Pratuangdejkul, B. Pharm, PhD. 8, and Somsak Akksilp, M.D. 2,6
pe
er
re
v
iew
ed
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Affiliations:
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1
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of Public Health, Bangkok, Thailand.
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Department of Medicine, College of Medicine, Rangsit University, Bangkok, Thailand.
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Department of Medicine, Monkutwattana Hospital, Bangkok, Thailand.
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Department of Medicine, Central Chest Institute of Thailand, Nonthaburi, Thailand.
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Department of Infectious Disease, Bamrasnaradura Infectious Disease Institute,
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Nonthaburi, Thailand.
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Department of Medical Services, Ministry of Public Health, Nonthaburi, Thailand.
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Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai,
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Thailand
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ot
tn
rin
Correspondence: Associate Professor Subsai Kongsaengdao, M.D., Division of
Neurology, Department of Medicine, 2 Rajavithi Hospital (Victory Monument),
Pr
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Faculty of Pharmacy, Mahidol University, Bangkok Thailand,
ep
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Department of Medicine, Rajavithi Hospital, Department of Medical Services, Ministry
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Ratchathewi Road, Bangkok 10400, Thailand, Tel +66 22 062 900 Ext 6120,
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Fax +66 23 545 477, Email skhongsa@gmail.com
FIGHT COVID-19 study {NCT04303299}
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This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3936499
ABSTRACT
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BACKGROUND
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Monotherapy with Remdesivir, Favipiravir, Lopinavir-Ritonavir, or Hydroxychloroquine
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has been evaluated for the treatment of coronavirus disease 2019 (Covid-19). No
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antiviral agents have yet been shown to be efficacious in terms of viral clearance and
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reduction of death in moderate to severe Covid-19 in randomized controlled trials.
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METHODS
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We conducted an open-label, randomized, controlled trial of various oral combinations
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of Favipiravir, Lopinavir-Ritonavir, Darunavir-Ritonavir, high-dose Oseltamivir, and
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Hydroxychloroquine in adults who were hospitalized with Covid-19. Ninety patients
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were randomly assigned to receive either 1) high-dose Oseltamivir and
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Hydroxychloroquine, 2) Lopinavir-Ritonavir and high-dose Oseltamivir, or 3) Darunavir-
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Ritonavir, high-dose Oseltamivir, and Hydroxychloroquine, compared to thirty voluntary
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quarantine patients without antiviral agent for mild Covid-19. In addition, two hundred
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patients were randomly assigned to receive 1) high-dose Oseltamivir and Lopinavir-
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Ritonavir, 2) Favipiravir and Lopinavir-Ritonavir, 3) high-dose Oseltamivir and
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Darunavir-Ritonavir, or 4) Favipiravir and Darunavir-Ritonavir and Hydroxychloroquine
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for moderate to severe Covid-19.
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RESULTS
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A total of 320 patients were enrolled. Those mild Covid-19 patients who received high-
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dose Oseltamivir and Hydroxychloroquine had a..
Late treatment
is less effective
is less effective
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