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

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04959786
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ivermectin,ribavirin ,nitazoxanide and zinc
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: INTERVENTION ARM

Drug: Ivermectin,ribavirin ,nitazoxanide and zinc
oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc
No Intervention: standard of care

Outcome Measures

Primary Outcome Measures

  1. Stabilization of oxygen [28 days]

    at room air more than 90%

  2. In-hospital and 28-day mortality [28 day]

Secondary Outcome Measures

  1. Negative conversion of SARS-CoV- 2 by Day 28 [28 day]

  2. Time to clinical improvement [28 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Hospital Mansoura Select A State Or Province Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hatem Elalfy, professor, Mansoura University
ClinicalTrials.gov Identifier:
NCT04959786
Other Study ID Numbers:
  • mu-med-2020-26
First Posted:
Jul 13, 2021
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Ribavirin
Ivermectin
Nitazoxanide

Study Results

No Results Posted as of Jul 13, 2021