Back to resultsNovel Regimens in COVID-19 Treatment
Primary Purpose
COVID, Corona Virus Infection
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
Inclusion Criteria:
- Patients with COVID-19 infection
Exclusion Criteria:
- Allergy or contraindication to the drugs.
Sites / Locations
- Tanta University, Assiut UniversityRecruiting
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nitazoxanide
Control group
Arm Description
Nitazoxanide with standard protocol of treatment
Standard protocol alone
Outcomes
Primary Outcome Measures
Number of patients with virological cure
the number of patients with virological cure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04382846
Brief Title
Novel Regimens in COVID-19 Treatment
Official Title
Nitazoxanide in Treatment of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Experimental
Arm Description
Nitazoxanide with standard protocol of treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard protocol alone
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Parazoxanide, Nanazoxid
Intervention Description
Nitazoxanide
Primary Outcome Measure Information:
Title
Number of patients with virological cure
Description
the number of patients with virological cure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with COVID-19 infection
Exclusion Criteria:
Allergy or contraindication to the drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sherief Abd-Elsalam, Ass. Prof.
Organizational Affiliation
ass. Prof. Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University, Assiut University
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, ass. prof
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sherief abd-elsalam
Email
sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32360581
Citation
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.
Results Reference
background
PubMed Identifier
32322397
Citation
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.
Results Reference
background
Learn more about this trial
Novel Regimens in COVID-19 Treatment
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