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

Phase 2

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: Ivermectin,ribavirin ,nitazoxanide and zinc

• Registration Number: NCT04959786
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged ≥18 years

  • Laboratory-confirmed SARS-CoV- 2 infection
  • Hospitalized patients

• need reservoir mask for oxygen support

• need HFNC for oxygen support

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Exclusion Criteria

• Mechanical ventilations for oxygen support
• Inability to take oral medications
• Pregnancy or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION ARM	Ivermectin,ribavirin ,nitazoxanide and zinc	-

Primary Outcome Measures

Name	Time	Method
Stabilization of oxygen	28 days	at room air more than 90%
In-hospital and 28-day mortality	28 day

Secondary Outcome Measures

Name	Time	Method
Time to clinical improvement	28 day
Negative conversion of SARS-CoV- 2 by Day 28	28 day

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Select A State Or Province, Egypt