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

March 15, 2021 updated by: Ahmed Essam, October 6 University

Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.

Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim of the study

  1. To assess the difference in patients' clinical status improvement between patients.
  2. To detect time to improvement in oxygenation among both groups.
  3. To detect duration of hospitalization and mortality rate in both groups.
  4. To detect incidence and duration of mechanical ventilation in both treatment arms.
  5. To monitor of adverse events of both drugs

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rania M Sarhan, PhD
  • Phone Number: 0001008789509

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni-Suef University
        • Contact:
          • Rania M Sarhan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
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
Drug: Remdesivir
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.
Drug: Tocilizumab
Tocilizumab 800 mg once.
Other Names:
  • Actemra
Drug: Lopinavir/ Ritonavir
Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
Other Names:
  • kaletra
Active Comparator: group 2
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.
Drug: Tocilizumab
Tocilizumab 800 mg once.
Other Names:
  • Actemra
Drug: Hydroxychloroquine
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.
Drug: Ivermectin
Ivermectin 36 mg at day 1,3 and 6.
Other Names:
  • Iverazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of clinical cure in each arm
Time Frame: through an average of 5-7 days
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs
through an average of 5-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Collaborators

Beni-Suef University

Investigators

  • Principal Investigator: Marian Boshra, PhD, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

March 10, 2021

Study Completion (Anticipated)

April 5, 2021

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-H-PhBSU-21011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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