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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959786
• Other study ID #: mu-med-2020-26
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Mansoura University
• Contact: Hatem elalfy, MD
• Phone: 01224790518
• Email: ELALFY2004[@]MANS.EDU.EG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Drug:
• Ivermectin,ribavirin ,nitazoxanide and zinc
oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stabilization of oxygen	at room air more than 90%	28 days
Primary	In-hospital and 28-day mortality		28 day
Secondary	Negative conversion of SARS-CoV- 2 by Day 28		28 day
Secondary	Time to clinical improvement		28 day