NCT04445311

Brief Summary

confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2020

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

May 31, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 19, 2020

Last Update Submit

June 19, 2020

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • time to be symptoms free

    duration from day 1 symptoms till 3 days without symptoms

    within 21 days after enrollment

Secondary Outcomes (4)

  • hospitalization

    within 21 days after enrollement

  • Mechanical ventilation

    within 21 days after enrollement

  • length of stay

    within one month days after enrollement

  • mortality

    within one month days after enrollement

Study Arms (2)

Ivermectin group

EXPERIMENTAL

group that will receive ivermectin plus standard of care ttt

Drug: Ivermectin

Control group

NO INTERVENTION

group that will receive standard of care ttt

Interventions

IvermectinDRUG

3 successive days ttt of ivermectin started within 48 hours of symptoms

Ivermectin group

Eligibility Criteria

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

You may qualify if:

  • COVID-19 patients during period of the study more than 18 years old

You may not qualify if:

  • refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with ivermectin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waheed Shouman

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Waheed Shouman, MD

CONTACT

+201114812048shouman66@gmail.com

Study Design

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

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 24, 2020

Study Start

May 31, 2020

Primary Completion

July 30, 2020

Study Completion

August 15, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

EG(1)