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Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

Primary Purpose

Covid19, Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Remdesivir
Hydroxychloroquine
Tocilizumab
Lopinavir/ Ritonavir
Ivermectin
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized adult patients with pneumonia evidenced by chest CT scan.
  • Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.

  • And at least one of the following:

    1. Respiratory frequency ≥30/min.
    2. Blood oxygen saturation ≤93% on room air (RA).
    3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300.
    4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2.

Exclusion Criteria:

  • Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3-fold the upper limit of the normal range.
  • Pregnancy.

Sites / Locations

  • Beni-suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1

group 2

Arm Description

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.

Outcomes

Primary Outcome Measures

Percentage of clinical cure in each arm
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs

Secondary Outcome Measures

Full Information

First Posted
February 25, 2021
Last Updated
March 15, 2021
Sponsor
October 6 University
Collaborators
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04779047
Brief Title
Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.
Official Title
Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Anticipated)
Study Completion Date
April 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.
Detailed Description
Aim of the study To assess the difference in patients' clinical status improvement between patients. To detect time to improvement in oxygenation among both groups. To detect duration of hospitalization and mortality rate in both groups. To detect incidence and duration of mechanical ventilation in both treatment arms. To monitor of adverse events of both drugs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Pneumonia
Keywords
covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra
Intervention Description
Tocilizumab 800 mg once.
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ Ritonavir
Other Intervention Name(s)
kaletra
Intervention Description
Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Iverazine
Intervention Description
Ivermectin 36 mg at day 1,3 and 6.
Primary Outcome Measure Information:
Title
Percentage of clinical cure in each arm
Description
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs
Time Frame
through an average of 5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized adult patients with pneumonia evidenced by chest CT scan. Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending. And at least one of the following: Respiratory frequency ≥30/min. Blood oxygen saturation ≤93% on room air (RA). Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2. Exclusion Criteria: Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3-fold the upper limit of the normal range. Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed E Abou warda, BSc
Phone
00201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rania M Sarhan, PhD
Phone
0001008789509
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Boshra, PhD
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-suef University
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania M Sarhan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34764044
Citation
Sarhan RM, Harb HS, Abou Warda AE, Salem-Bekhit MM, Shakeel F, Alzahrani SA, Madney YM, Boshra MS. Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients. J Infect Public Health. 2022 Jan;15(1):116-122. doi: 10.1016/j.jiph.2021.10.024. Epub 2021 Nov 2.
Results Reference
derived

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Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

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