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

NCT ID: NCT04959786

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-12-31

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

INTERVENTION ARM

Group Type: EXPERIMENTAL

Ivermectin,ribavirin ,nitazoxanide and zinc

Intervention Type: DRUG

oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ivermectin,ribavirin ,nitazoxanide and zinc

oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Hatem Elalfy

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Hospital

Al Mansurah, Select A State Or Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hatem elalfy, MD

Role: CONTACT

ELALFY2004@MANS.EDU.EG

01224790518

Facility Contacts

Hatem elalfy

Role: primary

elalfy_hatem66@yahoo.com

01224790518

Other Identifiers

mu-med-2020-26

Identifier Type: -

Identifier Source: org_study_id