NCT04951362

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

June 30, 2021

Last Update Submit

April 14, 2022

Conditions

Anosmia

Outcome Measures

Primary Outcomes (1)

  • regaining of smell

    regaining of smell

    within 14 days after enrollemen ]

Study Arms (2)

intranasal Ivermectin group

ACTIVE COMPARATOR

49 pateints with anosmia received ivermectin nanosuspension nasal spray

Drug: intranasal spray ivermectin

saline nasal spray

PLACEBO COMPARATOR

47 pateints with anosmia received saline nasal spray

Drug: intranasal spray ivermectin

Interventions

intranasal spray ivermectinDRUG

intranasal spray of saline

Also known as: saline spray
intranasal Ivermectin groupsaline nasal spray

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post covid19 anosmia
  • negative swab test for covid19

You may not qualify if:

  • other types of anosmia ,
  • no local or central other causes of anosmia
  • still active covid 19 pateints ( positive swab test )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaky Aref

Qina, Egypt

RECRUITING

Related Publications (1)

  • Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Ghweil AA, Sayed MAA, Rashad A, Mansour H, Abdelmaksoud AA. Possible Role of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Recovery of Post-COVID-19 Anosmia. Infect Drug Resist. 2022 Sep 19;15:5483-5494. doi: 10.2147/IDR.S381715. eCollection 2022.

    PMID: 36164334DERIVED

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Zaky Aref, MD

CONTACT

+201001771210doctor.aref@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass.professor

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 6, 2021

Study Start

April 20, 2021

Primary Completion

May 12, 2022

Study Completion

May 15, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations

EG(1)