Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Casirivimab and Imdevimab Drug Combination; Remdesivir; Favipiravir
Intervention description: antiviral Monoclonal Antibodies; antiviral drug; antiviral drug
Intervention MeSH terms: Remdesivir; Favipiravir; Casirivimab and imdevimab drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 265.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; Casirivimab & Imdevimab; Remdesivir; Favipravir

Summary:

      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.
    

Eligibility criteria:

        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.