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

Study Overview
=================
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 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

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

Conditions
-----------------
Covid19, Pneumonia

Intervention / Treatment
-----------------
* Drug: Remdesivir
* Drug: Hydroxychloroquine
* Drug: Tocilizumab
* Drug: Lopinavir/ Ritonavir
* Drug: Ivermectin


Participation Criteria
=================
Eligibility 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid19