At a glance
ClinicalIndex Comparison Record- ✓Age more than 12 years old
- ✓Weight at least 40 kg
- ✓Moderate, severe, or critical COVID-19 disease per WHO definition
- ✓PCR-confirmed positive for SARS-CoV-2 prior to enrollment
- ✕History of hypersensitivity or infusion-related reactions to monoclonal antibodies
- ✕Prior use of remdesivir or favipiravir
- ✕Current use of contraindicated antivirals including hydroxychloroquine, ivermectin, nitazoxanide, oseltamivir, acyclovir, ribavirin, lopinavir/ritonavir, sofosbuvir, daclatasvir, simeprevir, or azithromycin
- ✕Expected to die within 48 hours
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Casirivimab and Imdevimab Drug Combination, Remdesivir, and 1 other intervention for COVID-19. Completed, enrolled 265 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
antiviral Monoclonal Antibodies
antiviral drug
antiviral drug