NCT04959786

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

July 1, 2021

Last Update Submit

July 9, 2021

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (2)

  • Stabilization of oxygen

    at room air more than 90%

    28 days

  • In-hospital and 28-day mortality

    28 day

Secondary Outcomes (2)

  • Negative conversion of SARS-CoV- 2 by Day 28

    28 day

  • Time to clinical improvement

    28 day

Study Arms (2)

INTERVENTION ARM

EXPERIMENTAL
Drug: Ivermectin,ribavirin ,nitazoxanide and zinc

standard of care

NO INTERVENTION

Interventions

Ivermectin,ribavirin ,nitazoxanide and zincDRUG

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

INTERVENTION ARM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years
  • Laboratory-confirmed SARS-CoV- 2 infection
  • Hospitalized patients
  • need reservoir mask for oxygen support
  • need HFNC for oxygen support

You may not qualify if:

  • Mechanical ventilations for oxygen support
  • Inability to take oral medications
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Select A State Or Province, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

IvermectinZinc

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Central Study Contacts

Hatem elalfy, MD

CONTACT

01224790518ELALFY2004@MANS.EDU.EG

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 13, 2021

Study Start

April 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

EG(1)