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

Sponsor

October 6 University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04779047

Collaborator

Beni-Suef University (Other)

150

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

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

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2020

Anticipated Primary Completion Date :

Mar 10, 2021

Anticipated Study Completion Date :

Apr 5, 2021

Arms and Interventions

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

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: 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 Names:

Actemra

Drug: Ivermectin

Ivermectin 36 mg at day 1,3 and 6.

Other Names:

Iverazine

Outcome Measures

Primary Outcome Measures

Percentage of clinical cure in each arm [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 88 Years

Sexes Eligible for Study:

All

Accepts 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:

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.