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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779047
• Other study ID #: REC-H-PhBSU-21011
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: March 2021
• Source: October 6 University
• Contact: Ahmed E Abou warda, BSc
• Phone: 00201007647696
• Email: ahmed.essam[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 5, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

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.
• Hydroxychloroquine
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.
• Tocilizumab
Tocilizumab 800 mg once.
• Lopinavir/ Ritonavir
Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
• Ivermectin
Ivermectin 36 mg at day 1,3 and 6.

Locations

Country	Name	City	State
Egypt	Beni-suef University	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through an average of 5-7 days