NCT05246072

Brief Summary

The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_4 covid19

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

November 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 7, 2022

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

February 16, 2022

Last Update Submit

April 5, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • length of oxygen requirement

    3 months

Study Arms (3)

Ivermectin + colchicine + standard care

ACTIVE COMPARATOR

In addition to the local standard of care for COVID 19 patients, the patient will receive: Ivermectin + Colchicine

Drug: Ivermectin + colchicine

Colchicine + standard care

ACTIVE COMPARATOR

In addition to the local standard of care for COVID 19 patients, the patient will receive: Colchicine

Drug: Colchicine

standard care

NO INTERVENTION

Patients will receive Standard care

Interventions

Ivermectin + colchicineDRUG

In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine

Ivermectin + colchicine + standard care
ColchicineDRUG

In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine

Colchicine + standard care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide written informed consent prior to performing study procedures.
  • Currently hospitalized and requiring medical care for non-sever COVID-19.
  • One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).

You may not qualify if:

  • Tocilizumab use.
  • Mechanical ventilation
  • Requirement of oxygen supplementation \>8L/min on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

IvermectinColchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 18, 2022

Study Start

November 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

April 7, 2022

Record last verified: 2021-10

Locations

EG(1)