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Novel Regimens in COVID-19 Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382846
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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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
COVID Corona Virus Infection Drug: Nitazoxanide 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nitazoxanide
Nitazoxanide with standard protocol of treatment
 Drug: Nitazoxanide
Nitazoxanide
Other Name: Parazoxanide, Nanazoxid
No Intervention: Control group
Standard protocol alone


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with virological cure [ Time Frame: 6 months ]
    the number of patients with virological cure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with COVID-19 infection

Exclusion Criteria:

  • Allergy or contraindication to the drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382846


Contacts
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Tanta University, Assiut University Recruiting
Tanta, Egypt, 35111
Contact: Sherief Abd-Elsalam         
Principal Investigator: Sherief Abd-Elsalam, ass. prof         
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: sherief abd-elsalam       sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: sherief Abd-Elsalam, Ass. Prof. ass. Prof. Tropical Medicine
More Information
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Publications:

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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    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents