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Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779047
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Beni-Suef University
Information provided by (Responsible Party):
Ahmed Essam, October 6 University

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

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Drug: Remdesivir Drug: Hydroxychloroquine Drug: Tocilizumab Drug: Lopinavir/ Ritonavir Drug: Ivermectin Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine


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 Name: Actemra

Drug: Lopinavir/ Ritonavir
Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
Other Name: 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: 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: Tocilizumab
Tocilizumab 800 mg once.
Other Name: Actemra

Drug: Ivermectin
Ivermectin 36 mg at day 1,3 and 6.
Other Name: Iverazine




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

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): NCT04779047


Contacts
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Contact: Ahmed E Abou warda, BSc 00201007647696 ahmed.essam@o6u.edu.eg
Contact: Rania M Sarhan, PhD 0001008789509

Locations
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Egypt
Beni-suef University Recruiting
Banī Suwayf, Egypt
Contact: Rania M Sarhan, PhD         
Sponsors and Collaborators
October 6 University
Beni-Suef University
Investigators
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Principal Investigator: Marian Boshra, PhD Beni-Suef University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Essam, Principle Investigator, October 6 University
ClinicalTrials.gov Identifier: NCT04779047    
Other Study ID Numbers: REC-H-PhBSU-21011
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ahmed Essam, October 6 University:
covid19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
Lopinavir
Hydroxychloroquine
Ivermectin
Remdesivir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents