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

M

Mansoura University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

COVID-19 Pneumonia

Treatments

Drug: Ivermectin,ribavirin ,nitazoxanide and zinc

Study type

Interventional

Funder types

Other

Identifiers

NCT04959786
mu-med-2020-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

INTERVENTION ARM
Experimental group
Treatment:
Drug: Ivermectin,ribavirin ,nitazoxanide and zinc
standard of care
No Intervention group

Trial contacts and locations

1

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Central trial contact

Hatem elalfy, MD

Data sourced from clinicaltrials.gov

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