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Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia

Sponsor
South Valley University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04951362
Collaborator
(none)
117
Enrollment
1
Location
2
Arms
12.8
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia

Condition or Disease Intervention/Treatment Phase
  • Drug: intranasal spray ivermectin
 Phase 2/Phase 3

Detailed Description

ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia as one of the most characteresic symptoms of covid19 infection

Study Design

Study Type:
Interventional
Anticipated Enrollment :
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Studying the Expected Effect of Ivermectin Nanosuspension as Nasal Spray Upon Post covid19 Persistant Anosmia
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
May 12, 2022
Anticipated Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intranasal Ivermectin group

49 pateints with anosmia received ivermectin nanosuspension nasal spray

Drug: intranasal spray ivermectin
intranasal spray of saline
Other Names:
  • saline spray

    		•
    Placebo Comparator: saline nasal spray

    47 pateints with anosmia received saline nasal spray

    Drug: intranasal spray ivermectin
    intranasal spray of saline
    Other Names:
  • saline spray

    		•

    Outcome Measures

    Primary Outcome Measures

    1. regaining of smell [within 14 days after enrollemen ]]

      regaining of smell

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • post covid19 anosmia

    • negative swab test for covid19

    Exclusion Criteria:

    • other types of anosmia ,

    • no local or central other causes of anosmia

    • still active covid 19 pateints ( positive swab test )

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zaky Aref Qina Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zaky Aref, ass.professor, South Valley University
    ClinicalTrials.gov Identifier:
    NCT04951362
    Other Study ID Numbers:
    • SVU MED CIT0 23 4 21 1 122
    First Posted:
    Jul 6, 2021
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Anosmia
    Ivermectin

    Study Results

    No Results Posted as of Apr 22, 2022