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

Primary Purpose

COVID-19 Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ivermectin,ribavirin ,nitazoxanide and zinc
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

INTERVENTION ARM

standard of care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2021
Last Updated
July 9, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04959786
Brief Title
MANS-NRIZ Trial for COVID-19 Treatment : Extension Study
Official Title
Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION ARM
Arm Type
Experimental
Arm Title
standard of care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ivermectin,ribavirin ,nitazoxanide and zinc
Intervention Description
oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc
Primary Outcome Measure Information:
Title
Stabilization of oxygen
Description
at room air more than 90%
Time Frame
28 days
Title
In-hospital and 28-day mortality
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Negative conversion of SARS-CoV- 2 by Day 28
Time Frame
28 day
Title
Time to clinical improvement
Time Frame
28 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatem elalfy, MD
Phone
01224790518
Email
ELALFY2004@MANS.EDU.EG
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
State/Province
Select A State Or Province
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatem elalfy
Phone
01224790518
Email
elalfy_hatem66@yahoo.com

12. IPD Sharing Statement

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

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