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

March 15, 2021 updated by: Zaky Aref, South Valley University

Faculty of Medicine ,South Valley University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

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 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • early covid19 pateints

Exclusion Criteria:

  • children and pregnant women

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
[ Time Frame: within 14 days after enrollement ]

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

Helpful Links

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)

January 20, 2021

Primary Completion (Actual)

February 20, 2021

Study Completion (Anticipated)

March 20, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU MED CIT0 23 4 21 1 120

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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