Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (Casirivimab and Imdevimab) Versus Standard Antiviral Therapy (Remdesivir and Favipravir) as Antiviral Agent Against Corona Virus 2 Infection in Hospitalized COVID-19 Patients

MS.21.11.1737

Introduction: Corona Virus induced disease - 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of 2021 year, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, Casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipravir. Aim of Study: 1. To compare the efficacy of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir in reducing 28-day mortality in hospitalized patients with moderate, severe or critical COVID19 2. To compare safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir by monitoring hypersensitivity and infusion related reactions or other significant adverse effects Patients and Population: 265 COVID-19 Polymerase Chain Reaction (PCR) confirmed patients with indication for antiviral therapy is included in this study and will be divided into 3 groups (1:2:2): 1. Group A: REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)) 2. group B: Remdesivir 3. group C: Favipravir Methods: Study design is single blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are owned by Mansoura University Hospital (MUH), and prescribed by chest diseases lectures of faculty of medicine-Mansoura University. The duration of study is about 6 months after ethical approval.

2022-09-02

2022-12-28

2022-12-28

Completed

Early phase I

265

Inclusion Criteria: 1. age more than 12 years old. 2. weight not less than 40 kg. 3. Moderate, sever or critical COVID-19 disease as defined by WHO. 4. PCR- confirmed patients to be Positive before inclusion. Exclusion Criteria: 1. history of hypersensitivity or infusion related reactions after administration of monoclonal antibodies. 2. prior use of standard antiviral therapy (remedsvir or favipravir). 3. Current use of controversial antiviral therapy (hydroxychloroquine, ivermectin, nitazoxanide, oseltemavir, acyclovir, ribavirine, lopinvir/rotinvir, sofosfbuvir, decltasevir, semipirvir, azithromycin). 4. patients expected to die within 48 hours.

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2023-07-25