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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -383% Improvement Relative Risk Ventilation -37% Time to improvement 0% no CI Dischage or NEWS <3 17% Time to viral- -125% Favipiravir  FAVID  LATE TREATMENT  DB RCT Is late treatment with favipiravir beneficial for COVID-19? Double-blind RCT 44 patients in Spain (November 2020 - October 2021) Higher mortality (p=0.49) and slower viral clearance (p=0.51), not sig. c19early.org Horcajada et al., Pneumonia, August 2023 Favors favipiravir Favors control

Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)

Horcajada et al., Pneumonia, doi:10.1186/s41479-023-00124-6 (date from preprint), FAVID, EudraCT2020-002753-22
Aug 2023  
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Underpowered RCT with 44 hospitalized patients in Spain, showing no significant difference with favipiravir treatment in the primary outcome of time to clinical improvement, or in the secondary efficacy outcomes. Adverse events were more frequent in the favipiravir group (68%) compared to placebo (32%), but most were mild.
risk of death, 382.6% higher, RR 4.83, p = 0.49, treatment 2 of 23 (8.7%), control 0 of 21 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 28.
risk of mechanical ventilation, 37.0% higher, RR 1.37, p = 1.00, treatment 3 of 23 (13.0%), control 2 of 21 (9.5%), day 28.
time to improvement, no change, relative time 1.00, p = 0.45, treatment 23, control 21.
dischage or NEWS <3, 16.7% lower, relative time 0.83, p = 0.64, treatment 23, control 21.
time to viral-, 125.0% higher, relative time 2.25, p = 0.51, treatment 23, control 21.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Horcajada et al., 24 Aug 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, peer-reviewed, 30 authors, study period November 2020 - October 2021, trial EudraCT2020-002753-22 (FAVID).
This PaperFavipiravirAll
Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)
Juan P Horcajada, Rebeca Aldonza, Mónica Real, Silvia Castañeda-Espinosa, Elena Sendra, Joan Gomez-Junyent, Inmaculada López-Montesinos, Silvia Gómez-Zorrilla, Silvia Briansó, Montserrat Duran-Taberna, Andrés Fernández, Cristina Tarragó, Teresa Auguet-Quintillá, Maria Arenas-Miras, Itziar Arrieta‐aldea, Esperanza Cañas-Ruano, Roberto Güerri‐fernandez, Hernando Knobel, Maria Milagro Montero, Ivan Pelegrín, Francisca Sánchez‐martínez, Luisa Sorlí, Judith Villar‐garcía, Ajla Alibalic, Javier Camaron, Anna Maria Febrer, Laia Bertran, Andrea Barrientos
Pneumonia, doi:10.1186/s41479-023-00124-6
Purpose To design a randomized clinical trial to assess the efficacy and safety of favipiravir in patients with COVID-19 disease with pneumonia. Methods A randomized, double blind, placebo-controlled clinical trial of favipiravir in patients with COVID-19 pneumonia was conducted in three Spanish sites. Randomization 1:1 to favipiravir or placebo (in both groups added to the Standard of Care) was performed to treat the patients with COVID-19 pneumonia. The primary endpoint was "time to clinical improvement, " measured as an improvement for ≥ two categories on a 7-point WHO ordinal scale in an up to 28 days' time frame. Results Forty-four patients were randomized (23 in the favipiravir group and 21 in the placebo group). The median time to clinical improvement was not different between the favipiravir and the placebo arms (10 days for both groups) and none of the secondary endpoints showed significant differences between arms. The proportion of adverse events (both serious and non-serious) was statistically different between the favipiravir group (68.29%) and the placebo group (31.7%) (p = 0.019), but there was insufficient statistical evidence to correlate the degree of severity of the events with the treatment group. Conclusions Favipiravir administered for ten days to patients with COVID-19 and pneumonia did not improve outcomes compared with placebo. Although this is an underpowered negative study, efficacy results align with other randomized trials. However, in the present study, the non-serious adverse events were more frequent in the favipiravir group.
Authors' contributions Conceptualisation: JPH, TAQ, AF, RA and CT. Data collection: MR, SCE, ES, JGJ, ILM, SGZ, SB and MDT. Data quality: RA. Formal analyses: RA. Project administration: AF, RA and CT. Evidence synthesis: JPH, TAQ, RA and CT. Writing-original draft: JPH, TAQ, RA and CT. Funding acquisition: AF, RA and CT. Writing-review and editing: JPH, TAQ, RA and CT. All authors have read and agreed to the published version of the manuscript. Declarations Ethics approval and consent to participate The competing Ethics Committee of Hospital del Mar, Barcelona, Spain, approved the study protocol on 31 st of July 2020. Competing interests JPH has received consulting fees from Gilead, Menarini and TFF Pharmaceuticals, and participated in educational activities from MSD, Pfizer and Angelini. All other authors have no conflicts of interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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' 'https://doi.org/10.1016/j.antiviral.2013.09.015.', 'volume': '100', 'year': '2013'}, { 'DOI': '10.1016/j.antiviral.2014.02.014', 'author': 'L Oestereich', 'doi-asserted-by': 'publisher', 'first-page': '17', 'journal-title': 'Antiviral Res.', 'key': '124_CR11', 'unstructured': 'Oestereich L, Lüdtke A, Wur RS, Rieger T, Rieger T, Muñoz-Fontela C, et ' 'al. Successful treatment of advanced Ebola virus infection with T-705 ' '(favipiravir) in a small animal model. Antiviral Res. 2014;105:17–21.', 'volume': '105', 'year': '2014'}, { 'DOI': '10.1093/cid/ciw571', 'author': 'CQ Bai', 'doi-asserted-by': 'publisher', 'first-page': '1288', 'issue': '10', 'journal-title': 'Clin Infect Dis', 'key': '124_CR12', 'unstructured': 'Bai CQ, Mu JS, Kargb OD, Song YB, Niu WK, Nie WM, et al. Clinical and ' 'Virological Characteristics of Ebola Virus Disease Patients Treated With ' 'Favipiravir (T-705)-Sierra Leone, 2014. Clin Infect Dis. 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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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