Novel Regimens in COVID-19 Treatment

December 2, 2020 updated by: Sherief Abd-Elsalam, Tanta University

Nitazoxanide in Treatment of COVID-19

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019. Some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
      • Tanta, Egypt, 35111
        • Recruiting
        • Tanta University, Assiut University
        • Principal Investigator:
          • Sherief Abd-Elsalam, ass. prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with COVID-19 infection

Exclusion Criteria:

  • Allergy or contraindication to the drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitazoxanide
Nitazoxanide with standard protocol of treatment
Drug: Nitazoxanide
Nitazoxanide
Other Names:
  • Parazoxanide, Nanazoxid
No Intervention: Control group
Standard protocol alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with virological cure
Time Frame: 6 months
the number of patients with virological cure
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: sherief Abd-Elsalam, Ass. Prof., ass. Prof. Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tanta covid treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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