Remdesivir Efficacy In Management Of COVID-19 Patients

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04853901
Collaborator
(none)
77
1
2
7.1
10.8

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jul 27, 2020
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • Plaquenil
  • Drug: Standard of care_2
    Methylprednisolone 1-2mg/kg for 5-7 days
    Other Names:
  • Steroid
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluation of viral clearance [14 days]

      Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center Cairo Non-US Egypt 11566

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Hany E Dabbous, M.D, Faculty of Medicine Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 22, 2021
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2021