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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05502081
Recruitment Status : Completed
First Posted : August 16, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Ahmed H Hassan, PharmD, Mansoura University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Casirivimab and Imdevimab Drug Combination Drug: Remdesivir Drug: Favipiravir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2021
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: casirivimab and imdevimab
casirivimab and imdevimab, vials 1.2 gm (1200 mg of combined antibodies) diluted in 250 ml 0.9% sodium chloride solution as single I.V infusion over 30-60 minutes.
Drug: Casirivimab and Imdevimab Drug Combination
antiviral Monoclonal Antibodies
Other Name: REGN-COV2

Experimental: Remdesivir
Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes
Drug: Remdesivir
antiviral drug
Other Name: Veklury

Experimental: Favipravir
Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) or 1800 mg (9 tablets) orally or in Ryle tube / 12 hours Day 2-5 or day 2-10 (maintenance dose): 600 mg (3 tablets) or 800 mg (4 tablets) orally or in Ryle tube / 12 hours
Drug: Favipiravir
antiviral drug
Other Name: Avigan




Primary Outcome Measures :
  1. 28-days mortality rate [ Time Frame: 28 days ]
    Dead or alive

  2. PCR test results at end of hospital visit [ Time Frame: up to 60 days ]
    Positive or negative

  3. incidence of infusion related reactions, hypersensitivity reactions and any Serious adverse events [ Time Frame: up to 60 days ]
    yes or no


Secondary Outcome Measures :
  1. Need for invasive mechanical ventilation [ Time Frame: up to 60 days ]
    yes or no

  2. oxygen support duration (days) [ Time Frame: up to 60 days ]
    in days

  3. Time to clinical improvement (defined as 2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first [ Time Frame: up to 60 days ]
    in days

  4. duration of hospitalization and ICU stay [ Time Frame: up to 60 days ]
    in days

  5. Sequential organ function assessment score on day 0,3,7,14, and 28. [ Time Frame: up to 60 days ]
    minimum 0 to maximum 24, higher scores mean worse outcomes

  6. COVID-19 world health organization disease progression scale [ Time Frame: up to 60 days ]
    minimum 0 to maximum 10, higher scores mean worse outcomes

  7. CRP [ Time Frame: up to 60 days ]
    continuous level

  8. AST [ Time Frame: up to 60 days ]
    continuous level

  9. ferritin [ Time Frame: up to 60 days ]
    continuous level

  10. LDH [ Time Frame: up to 60 days ]
    continuous level

  11. D-dimer [ Time Frame: up to 60 days ]
    continuous level

  12. ALT [ Time Frame: up to 60 days ]
    Number of participants with abnormal laboratory test results

  13. Albumin [ Time Frame: up to 60 days ]
    Number of participants with abnormal laboratory test results

  14. Bilirubin [ Time Frame: up to 60 days ]
    Number of participants with abnormal laboratory test results

  15. serum creatinine [ Time Frame: up to 60 days ]
    Number of participants with abnormal laboratory test results


Other Outcome Measures:
  1. Glasgow Coma Score [ Time Frame: up to 60 days ]
    minimum 0 to maximum 15, higher scores mean better outcomes

  2. PO2 [ Time Frame: up to 60 days ]
    continuous level

  3. PCO2 [ Time Frame: up to 60 days ]
    continuous level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05502081


Locations
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Egypt
El-gomhoria St
Mansoura, El-dkhalia, Egypt, 050
Sponsors and Collaborators
Mansoura University Hospital
Investigators
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Study Director: Shar K Hegazy, prof Tanta Unversity
  Study Documents (Full-Text)

Documents provided by Ahmed H Hassan, PharmD, Mansoura University Hospital:
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications:
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines [updated September 29, 2021. Available from: https://www.covid19treatmentguidelines.nih.gov.
Aleem A, Kothadia JP. Remdesivir. StatPearls. Treasure Island (FL): StatPearls Publishing Copyright © 2021, StatPearls Publishing LLC.; 2021
FDA. EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COV (casirivimab and imdevimab): Food and Drug Adminsteration (FDA); 2021 [updated 16/9/2021. first:[FACT SHEET FOR HEALTH CARE PROVIDERS,]. Available from: https://www.fda.gov/media/145611/download
WHO COVID19 disease progression ordinal scale. February 18, 2020. [Available from: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf

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Responsible Party: Ahmed H Hassan, PharmD, Principal Investigator, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT05502081    
Other Study ID Numbers: MS.21.11.1737
35039/11/21 ( Other Identifier: Tanta University )
First Posted: August 16, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the end and publication of the study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After the end and publication of the study
Access Criteria: all will be accessiable

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed H Hassan, PharmD, Mansoura University Hospital:
COVID-19
Casirivimab & Imdevimab
Remdesivir
Favipravir
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Favipiravir
Remdesivir
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action