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Remdesivir Efficacy In Management Of 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: NCT04853901
Recruitment Status : Completed
First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Hany Dabbous, Ain Shams University

Study Description
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Brief Summary:
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Remdesivir Drug: Standard of care_1 Drug: Standard of care_2 Phase 3

Detailed Description:

The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.

The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remdesivir Efficacy In Management Of COVID-19 Patients
Actual Study Start Date : July 27, 2020
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days
 Drug: Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Other Name: Veklury
Active Comparator: Standard of care therapy
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
 Drug: Standard of care_1
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Other Name: Plaquenil

Drug: Standard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Other Name: Steroid


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of viral clearance [ Time Frame: 14 days ]
    Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.

Must have severe or immediately life-threatening COVID-19,

  • Severe disease is defined as:

    • Dyspnea,
    • Respiratory frequency ≥ 30/min,
    • Blood oxygen saturation ≤ 93%,
    • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours

  • Life-threatening disease is defined as:

    • respiratory failure,
    • septic shock, and/or
    • multiple organ dysfunction or failure
  • Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative

Exclusion Criteria:

  • Mild to moderately affected COVID 19 confirmed patients.
  • pregnancy, lactation.
  • known hepatic failure.
  • Patient who is not likely to comply to study procedures.
  • Creatine clearance <30 ml/min.
  • Elevated transaminases > 5 fold ULN.
Contacts and Locations
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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): NCT04853901


Locations
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Egypt
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hany E Dabbous, M.D Faculty of Medicine Ain Shams University
More Information
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Responsible Party: Hany Dabbous, Professor of Tropical Medicine Faculty of Medicine Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT04853901    
Other Study ID Numbers: FMASU P56a/ 2020
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents