Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05246072

Collaborator

(none)

135

Enrollment

Location

Arms

3.9

Actual Duration (Months)

34.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ivermectin + colchicine Drug: Colchicine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ivermectin + colchicine + standard care In addition to the local standard of care for COVID 19 patients, the patient will receive: Ivermectin + Colchicine	Drug: Ivermectin + colchicine In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine
Active Comparator: Colchicine + standard care In addition to the local standard of care for COVID 19 patients, the patient will receive: Colchicine	Drug: Colchicine In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine
No Intervention: standard care Patients will receive Standard care

Arm

Intervention/Treatment

Active Comparator: Ivermectin + colchicine + standard care

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

Drug: Ivermectin + colchicine

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

Active Comparator: Colchicine + standard care

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

Drug: Colchicine

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

No Intervention: standard care

Patients will receive Standard care

Outcome Measures

Primary Outcome Measures

length of oxygen requirement [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05246072

Other Study ID Numbers:

FAMSU R 179 / 2021

First Posted:

Feb 18, 2022

Last Update Posted:

Apr 7, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Ivermectin

Colchicine

Study Results

No Results Posted as of Apr 7, 2022