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

Phase 4

• Conditions: Pneumonia; Covid19
• Interventions: Drug: Hydroxychloroquine; Drug: Remdesivir; Drug: Tocilizumab; Drug: Lopinavir/ Ritonavir; Drug: Ivermectin

• Registration Number: NCT04779047
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-25
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-03
• Primary Completion: 2021-03-10
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Study Completion: 2021-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Lopinavir/ Ritonavir	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
group 2	Hydroxychloroquine	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.
group 1	Remdesivir	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
group 1	Tocilizumab	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
group 2	Tocilizumab	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.
group 2	Ivermectin	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beni-suef University; 🇪🇬 Banī Suwayf, Egypt