NCT04716569

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

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
150

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2 covid19

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

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

January 19, 2021

Last Update Submit

March 15, 2021

Conditions

Covid19

Keywords

Ivermectin intranasal spray in covid19

Outcome Measures

Primary Outcomes (1)

  • progression of covid 19 clinical picture

    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 ]

Study Arms (2)

intranasal Ivermectin group

EXPERIMENTAL

Ivermectin group Patients who will receive intranasal ivermectin

Drug: intranasal ivermectin spray

Control group

OTHER

patients who will receive regular protocol drugs

Drug: intranasal ivermectin spray

Interventions

intranasal ivermectin sprayDRUG

usage of ivermectin as intranasal spray for treating early covid patiens

Control groupintranasal Ivermectin group

Eligibility Criteria

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

You may qualify if:

  • early covid19 pateints

You may not qualify if:

  • children and pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaky Aref

Qina, Qena Governorate, 83511, Egypt

RECRUITING

Related Publications (1)

  • Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Rashad A, Hassan RG, Abdelmaksoud AA. Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19. Int J Nanomedicine. 2021 Jun 15;16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.

    PMID: 34163159DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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

January 19, 2021

First Posted

January 20, 2021

Study Start

January 20, 2021

Primary Completion

February 20, 2021

Study Completion

March 20, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

EG(1)