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Remdesivir Efficacy In Management Of COVID-19 Patients

Primary Purpose

Covid19

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Remdesivir
Standard of care_1
Standard of care_2
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remdesivir

Standard of care therapy

Arm Description

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

Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
April 17, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04853901
Brief Title
Remdesivir Efficacy In Management Of COVID-19 Patients
Official Title
Remdesivir Efficacy In Management Of COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remdesivir
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care therapy
Arm Type
Active Comparator
Arm Description
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
Veklury
Intervention Description
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Intervention Type
Drug
Intervention Name(s)
Standard of care_1
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Intervention Type
Drug
Intervention Name(s)
Standard of care_2
Other Intervention Name(s)
Steroid
Intervention Description
Methylprednisolone 1-2mg/kg for 5-7 days
Primary Outcome Measure Information:
Title
Evaluation of viral clearance
Description
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany E Dabbous, M.D
Organizational Affiliation
Faculty of Medicine Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
City
Cairo
State/Province
Non-US
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Remdesivir Efficacy In Management Of COVID-19 Patients

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