NCT04382846

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
55mo left

Started May 2020

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress58%
May 2020Dec 2030

First Submitted

Initial submission to the registry

May 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

10.6 years

First QC Date

May 7, 2020

Last Update Submit

December 2, 2020

Conditions

COVIDCorona Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with virological cure

    the number of patients with virological cure

    6 months

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

Nitazoxanide with standard protocol of treatment

Drug: Nitazoxanide

Control group

NO INTERVENTION

Standard protocol alone

Interventions

NitazoxanideDRUG

Nitazoxanide

Also known as: Parazoxanide, Nanazoxid
Nitazoxanide

Eligibility Criteria

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

You may qualify if:

  • Patients with COVID-19 infection

You may not qualify if:

  • Allergy or contraindication to the drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tanta University, Assiut University

Tanta, 35111, Egypt

RECRUITING

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

Related Publications (2)

  • Kelleni MT. Nitazoxanide/azithromycin combination for COVID-19: A suggested new protocol for early management. Pharmacol Res. 2020 Jul;157:104874. doi: 10.1016/j.phrs.2020.104874. Epub 2020 Apr 30.

    PMID: 32360581BACKGROUND

  • Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.

    PMID: 32322397BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • sherief Abd-Elsalam, Ass. Prof.

    ass. Prof. Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 11, 2020

Study Start

May 8, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)