Favipiravir treatment does not influence disease progression among adult patients hospitalized with moderate-to-severe COVID-19: a prospective, sequential cohort study from Hungary
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Abstract
Data suggests that favipiravir (FVP) could be used against SARS-CoV-2. Our aim was to investigate the role of FVP in COVID-19 treatment. A prospective sequential cohort study was performed among adults hospitalized at our center between March and August 2020 with moderate-to-severe, PCR-confirmed COVID-19. For diagnosis and severity, ECDC and WHO definitions were utilized. Patients were screened for inclusion by a priori criteria and included in the FVP cohort if standard-of-care (SOC) + FVP or the non-FVP cohort if SOC ± other antivirals without FVP were administered for > 48 h from diagnosis. Treatment allocation was done per national guidelines, based on severity and drug availability. Primary endpoint was disease progression, a composite of 14-day all-cause death, need for mechanical ventilation, or immunomodulatory therapy. The impact of FVP exposure on disease progression was analyzed by binomial logistic regression. In all, 150 patients were included, 75 in each cohort. Disease progression (17/75, 22.7% vs. 10/75, 13.3%, p = 0.13), 14-day all-cause death (9/75, 12.0% vs. 10/75, 13.3%, p = 0.8), and need for mechanical ventilation (8/75, 10.7% vs. 4/75, 5.3%, p = 0.22) were similar, while immunomodulatory therapies were required more frequently among patients receiving FVP (10/75, 13.3% vs. 1/75, 1.3%, p < 0.01). The use of favipiravir was not retained as a protective factor against disease progression in multivatiate analysis. Time to antiviral therapy from PCR positivity, disease severity, need for oxygen supportation, and ICU admittance rates did not differ statistically between cohorts. In this study, favipiravir did not seem to positively affect disease progression.
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SciScore for 10.1101/2020.11.26.20238014: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The institutional review board approved the study protocol, and informed consent was obtained from every patient.
Consent: The institutional review board approved the study protocol, and informed consent was obtained from every patient.Randomization COVID-19 antiviral therapies are allocated per protocol, in an open-label and non-randomized fashion (excluding patients in randomized clinical trials), but allocation is affected by drug availability on a national level. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data collection was completed with Microsoft … SciScore for 10.1101/2020.11.26.20238014: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The institutional review board approved the study protocol, and informed consent was obtained from every patient.
Consent: The institutional review board approved the study protocol, and informed consent was obtained from every patient.Randomization COVID-19 antiviral therapies are allocated per protocol, in an open-label and non-randomized fashion (excluding patients in randomized clinical trials), but allocation is affected by drug availability on a national level. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data collection was completed with Microsoft Office Excel 2016, tests were calculated using IBM SPSS Statistics 23. Microsoft Office Excelsuggested: (Microsoft Excel, RRID:SCR_016137)SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:4.3 Limitations: Our study had several limitations. As the pandemic is still ongoing, knowledge about COVID-19 is changing fast, and despite best efforts, per protocol treatment allocation might have been lagging behind literature evidence. National drug availability might have biased treatment allocation. The initiation of alternative antiviral medications might have been biased by (contra)indication. Age and comorbidity differences between our cohorts could represent the temporal progression of the epidemic in Hungary: younger people were affected sooner in larger numbers, and this might have confounded some baseline characteristics due to the sequential cohort design. The number of included patients is relatively low, however, an exact a priori study size calculation was not feasible due to study design and enrollment. Chest CT was not readily obtainable from some patients due to technical reasons.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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