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

April 14, 2022 updated by: Zaky Aref, South Valley University

Studying the Expected Effect of Ivermectin Nanosuspension as Nasal Spray Upon Post covid19 Persistant Anosmia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

117

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
regaining of smell
Time Frame: within 14 days after enrollemen ]
regaining of smell
within 14 days after enrollemen ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Anticipated)

May 12, 2022

Study Completion (Anticipated)

May 15, 2022

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU MED CIT0 23 4 21 1 122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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