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

NCT ID: NCT05246072

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ivermectin + colchicine + standard care

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

Ivermectin + Colchicine

Group Type ACTIVE_COMPARATOR

Ivermectin + colchicine

Intervention Type DRUG

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

Colchicine + standard care

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

Colchicine

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

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

standard care

Patients will receive Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ivermectin + colchicine

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

Intervention Type DRUG

Colchicine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FAMSU R 179 / 2021

Identifier Type: -

Identifier Source: org_study_id

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