MedTrace Logo

Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients

NCT05502081 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2023-07-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Casirivimab and Imdevimab Drug Combination

antiviral Monoclonal Antibodies

DRUG

Remdesivir

antiviral drug

DRUG

Favipiravir

antiviral drug

Sponsors & Collaborators

  • Mansoura University Hospital

    lead OTHER

Principal Investigators

  • Shar K Hegazy, prof · Tanta Unversity

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2022-12-28
Completion
2022-12-28
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502081 on ClinicalTrials.gov