Novel Regimens in COVID-19 Treatment
Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04382846
Collaborator
(none)
160
2
2
126.8
80
0.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nitazoxanide in Treatment of COVID-19
Actual Study Start Date
:
May 8, 2020
Anticipated Primary Completion Date
:
Dec 1, 2030
Anticipated Study Completion Date
:
Dec 1, 2030
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nitazoxanide Nitazoxanide with standard protocol of treatment |
Drug: Nitazoxanide
Nitazoxanide
Other Names:
|
| No Intervention: Control group Standard protocol alone |
Outcome Measures
Primary Outcome Measures
- Number of patients with virological cure [6 months]
the number of patients with virological cure
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with COVID-19 infection
Exclusion Criteria:
- Allergy or contraindication to the drugs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta University, Assiut University | Tanta | Egypt | 35111 | |
| 2 | Sherief Abd-Elsalam | Tanta | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: sherief Abd-Elsalam, Ass. Prof., ass. Prof. Tropical Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
Responsible Party:
Sherief Abd-Elsalam,
Ass. Prof. Tropical Medicine,
Tanta University
ClinicalTrials.gov Identifier:
NCT04382846
Other Study ID Numbers:
- tanta covid treatment
First Posted:
May 11, 2020
Last Update Posted:
Dec 4, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: