MANS-NRIZ Trial for COVID-19 Treatment : Extension Study

Study Overview
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Brief Summary
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This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

Detailed Description
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This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

Official Title
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Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study

Conditions
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COVID-19 Pneumonia

Intervention / Treatment
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* Drug: Ivermectin,ribavirin ,nitazoxanide and zinc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years Laboratory-confirmed SARS-CoV- 2 infection Hospitalized patients need reservoir mask for oxygen support need HFNC for oxygen support Exclusion Criteria: Mechanical ventilations for oxygen support Inability to take oral medications Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERVENTION ARM<br> | Drug: Ivermectin,ribavirin ,nitazoxanide and zinc<br>* oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc<br>|
| No Intervention: standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stabilization of oxygen | at room air more than 90% | 28 days | 
| In-hospital and 28-day mortality |  | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative conversion of SARS-CoV- 2 by Day 28 |  | 28 day | 
| Time to clinical improvement |  | 28 day |