4.6 Article

Favipiravir, lopinavir-ritonavir, or combination therapy (FLARE): A randomised, double-blind, 2 x 2 factorial placebo-controlled trial of early antiviral therapy in COVID-19

Related references

Note: Only part of the references are listed.
Article Immunology

AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Andrey A. Ivashchenko et al.

Summary: In May 2020, AVIFAVIR, an RNA polymerase inhibitor, was granted fast-track marketing authorization by the Russian Ministry of Health for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR demonstrated a 62.5% viral clearance rate within 4 days for SARS-CoV-2 patients and was shown to be safe and well-tolerated.

CLINICAL INFECTIOUS DISEASES (2021)

Article Infectious Diseases

An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19

Florence Ader et al.

Summary: This study evaluated the clinical, virological, and safety outcomes of different treatment options in hospitalized COVID-19 patients, showing that lopinavir/ritonavir, lopinavir/ritonavir-IFN-beta-1a, and hydroxychloroquine did not improve the clinical status or SARS-CoV-2 clearance in respiratory tract specimens.

CLINICAL MICROBIOLOGY AND INFECTION (2021)

Article Infectious Diseases

Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia

Faryal Khamis et al.

Summary: The study evaluated the therapeutic effectiveness of favipiravir combined with inhaled interferon beta 1b compared to hydroxychloroquine in adult patients hospitalized with moderate to severe COVID-19 pneumonia. The results showed no significant differences in inflammatory markers, length of hospital stay, discharges, or overall mortality between the two treatment groups. In conclusion, there were no differences in clinical outcomes between favipiravir plus inhaled interferon beta 1b and hydroxychloroquine in this patient population.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

Article Medicine, General & Internal

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19

D. M. Weinreich et al.

Summary: Recent data indicate that complications and death from Covid-19 may be related to high viral loads. In this trial involving nonhospitalized patients, a cocktail of two neutralizing monoclonal antibodies (REGN-COV2) reduced viral load, with a greater effect in patients with no immune response or high viral load at baseline. Safety outcomes were similar between REGN-COV2 dose groups and the placebo group.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

Review Pharmacology & Pharmacy

Systematic Review and Patient-Level Meta-Analysis of SARS-CoV-2 Viral Dynamics to Model Response to Antiviral Therapies

Silke Gastine et al.

Summary: A meta-analysis was conducted to study the viral dynamics of SARS-CoV-2 in humans, revealing that older age, male gender, and more severe illness are associated with longer viral clearance times. Remdesivir and interferon combined with ribavirin were found to accelerate viral clearance, suggesting further investigation into combination therapy. The study has established a viral dynamic dataset and NLME model for designing and analyzing antiviral trials.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

Article Immunology

Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia

Masoud Solaymani-Dodaran et al.

Summary: The study found that adding Favipiravir to the treatment protocol did not reduce ICU admissions, intubations, or in-hospital mortality compared to the Lopinavir/Ritonavir regimen. There were also no significant differences in time to clinical recovery and length of hospital stay between the two treatment groups.

INTERNATIONAL IMMUNOPHARMACOLOGY (2021)

Article Infectious Diseases

Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial

Zarir F. Udwadia et al.

Summary: The study aimed to assess the efficacy and safety of favipiravir in adults with mild-to-moderate COVID-19. Results showed a significant improvement in time to clinical cure with favipiravir, although there was no statistically significant difference in viral shedding cessation time.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

Article Medicine, General & Internal

Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab

Anil Gupta et al.

Summary: In this study, among nonhospitalized patients with symptomatic Covid-19, sotrovimab treatment significantly reduced the risk of disease progression leading to hospitalization or death compared to placebo. Patients receiving sotrovimab also had a lower rate of serious adverse events.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

Article Multidisciplinary Sciences

An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19

Dafydd R. Owen et al.

Summary: PF-07321332, an orally bioavailable SARS-CoV-2 main protease inhibitor, has been discovered with in vitro pan-human coronavirus antiviral activity and excellent off-target selectivity and in vivo safety profiles. This new drug has shown promise in countering the threat of COVID-19 with its oral activity and safety in clinical trials.

SCIENCE (2021)

Letter Medicine, Research & Experimental

Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial

Li-An K. Brown et al.

Summary: The FLARE trial aims to assess the impact of different antiviral treatment regimens on the viral load of SARS-CoV-2 in COVID-19 patients. Conducted in the UK, the trial includes non-hospitalized adults with early-stage symptoms who meet specific inclusion criteria.

TRIALS (2021)

Article Multidisciplinary Sciences

Saliva is superior over nasopharyngeal swab for detecting SARS-CoV2 in COVID-19 patients

Getachew Tesfaye Beyene et al.

Summary: Saliva can be a good alternative sample for diagnosing COVID-19 patients, showing higher yield and viral load compared to NPS samples.

SCIENTIFIC REPORTS (2021)

Article Infectious Diseases

Saliva is a reliable and accessible source for the detection of SARS-CoV-2

Luis A. Herrera et al.

Summary: The study demonstrates that saliva sampling is comparable to nasopharyngeal swab sampling in terms of sensitivity and reproducibility for detecting SARS-CoV-2, with saliva showing higher concordance and viral concentration. Additionally, saliva samples are stable without preservatives and can still detect positive results after an extended period of time. Benefits include cost reduction and increased sample analysis efficiency through pooling.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

Article Infectious Diseases

Pharmacokinetic modelling to estimate intracellular favipiravir ribofuranosyl-5′-triphosphate exposure to support posology for SARS-CoV-2

Henry Pertinez et al.

Summary: This study utilized a mathematical model to simulate the intracellular pharmacokinetics of the active metabolite of favipiravir, revealing that despite rapid clearance of the parent drug from plasma, sufficient intracellular active metabolite may be maintained across the dosing interval. The predicted regimen of 1200 mg twice daily of favipiravir is estimated to maintain intracellular active metabolite concentrations above the Km for the SARS-CoV-2 polymerase for 9 days. Further evaluation of favipiravir in combination with other antivirals for SARS-CoV-2 treatment is recommended.

JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY (2021)

Article Biochemical Research Methods

Validation of a combined ELISA to detect IgG, IgA and IgM antibody responses to SARS-CoV-2 in mild or moderate non-hospitalised patients

A. M. Cook et al.

Summary: An ELISA assay targeting SARS-CoV-2 trimeric spike glycoprotein for the detection of IgG, IgA and IgM antibodies showed high sensitivity and specificity in non-hospitalised adults with mild or moderate disease. The assay was stable, free from cross-reactivity, and the use of dried blood spots made it accessible to a wider community.

JOURNAL OF IMMUNOLOGICAL METHODS (2021)

Article Infectious Diseases

Efficacy and Safety of Favipiravir in Moderate COVID-19 Pneumonia Patients without Oxygen Therapy: A Randomized, Phase III Clinical Trial

Masaharu Shinkai et al.

Summary: The study found that favipiravir may be an option for treating moderate COVID-19 pneumonia, with better effects in patients with obesity or coexisting conditions. However, the risk of adverse events, including hyperuricemia, should be carefully considered when using favipiravir.

INFECTIOUS DISEASES AND THERAPY (2021)

Article Multidisciplinary Sciences

Favipiravir at high doses has potent antiviral activity in SARS-CoV-2-infected hamsters, whereas hydroxychloroquine lacks activity

Suzanne J. F. Kaptein et al.

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2020)

Article Pharmacology & Pharmacy

Timing of Antiviral Treatment Initiation is Critical to Reduce SARS-CoV-2 Viral Load

Antonio Goncalves et al.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2020)

Article Public, Environmental & Occupational Health

Post-exposure prophylaxis for Middle East respiratory syndrome in healthcare workers

S. Y. Park et al.

JOURNAL OF HOSPITAL INFECTION (2019)

Article Infectious Diseases

Favipiravir pharmacokinetics in Ebola-infected patients of the JIKI trial reveals concentrations lower than targeted

Thi Huyen Tram Nguyen et al.

PLOS NEGLECTED TROPICAL DISEASES (2017)