NCT04422561

Brief Summary

asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 31, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
1 month until next milestone

Results Posted

Study results publicly available

August 27, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

June 6, 2020

Results QC Date

August 23, 2020

Last Update Submit

August 23, 2020

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)

    history taking and clinical examination

    within 14 days after enrollement

Secondary Outcomes (1)

  • Development of COVID

    within 14 days after enrollement

Study Arms (2)

Ivermectin group

EXPERIMENTAL

Contacts who will receive prophylactic ivermectin

Drug: Ivermectin Tablets

Control group

NO INTERVENTION

Contacts who will be only observed without prophylaxis

Interventions

Ivermectin TabletsDRUG

two doses 72 hours apart

Ivermectin group

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • family contact of confirmed COVID-19 case

You may not qualify if:

  • refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Waheed Shouman
Organization
Zagazig University
shouman66@gmail.com
+201114812048

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of chest diseases

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 9, 2020

Study Start

May 31, 2020

Primary Completion

July 14, 2020

Study Completion

July 27, 2020

Last Updated

August 27, 2020

Results First Posted

August 27, 2020

Record last verified: 2020-08

Locations

EG(1)