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Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19

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: NCT04716569
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Zaky Aref, South Valley University

Brief Summary:
Ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well

Condition or disease Intervention/treatment Phase
Covid19 Drug: intranasal ivermectin spray Phase 2 Phase 3

Detailed Description:
150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Faculty of Medicine ,South Valley University
Actual Study Start Date : January 20, 2021
Actual Primary Completion Date : February 20, 2021
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: intranasal Ivermectin group
Ivermectin group Patients who will receive intranasal ivermectin
Drug: intranasal ivermectin spray
usage of ivermectin as intranasal spray for treating early covid patiens

Control group
patients who will receive regular protocol drugs
Drug: intranasal ivermectin spray
usage of ivermectin as intranasal spray for treating early covid patiens




Primary Outcome Measures :
  1. progression of covid 19 clinical picture [ Time Frame: [ Time Frame: within 14 days after enrollement ] ]
    progress of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)with radiological assesment and blood tests



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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:

  • early covid19 pateints

Exclusion Criteria:

  • children and pregnant women

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): NCT04716569


Locations
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Egypt
Zaky Aref Recruiting
Qinā, Qina, Egypt, 83511
Contact: Zaky Aref, MD    01001771210    doctor.aref@hotmail.com   
Contact: mohammed hosny hassaan, MD    00201115390073    mohammedhosnyhassaan@yahoo.com   
Sponsors and Collaborators
South Valley University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zaky Aref, ass.professor, South Valley University
ClinicalTrials.gov Identifier: NCT04716569    
Other Study ID Numbers: SVU MED CIT0 23 4 21 1 120
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zaky Aref, South Valley University:
Ivermectin intranasal spray in covid19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents