COVidIVERmectin: Ivermectin for Treatment of Covid-19

NCT ID: NCT04438850

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-06-08

Brief Summary

Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection.

Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres.

In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

Detailed Description

Primary objectives

The study is aimed:

1. at defining if ivermectin, administered at dosage of 600 μg/kg or 1200 μg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection,

2. at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7.

Secondary objectives To assess

1. the temporal profile of viral load at baseline, day 7, 14 and 30

2. the time to clinical cure (for symptomatic patients)

3. the proportion of patients with virological clearance at day 14 and 30.

4. the hospitalization rate.

5. the COVID-19 Severity Score at day 14 and 30

STUDY DESIGN

This is a multicentre, prospective, randomized, double-blind, adaptive phase II dose finding study.

Patients meeting the inclusion criteria will be asked to participate to the study and randomized in a 1:1:1 ratio to either:

• Placebo arm (arm A): placebo will be identical in appearance to ivermectin in order to preserve blinding and will be administered p.o. at empty stomach with water once daily, for 5 days
• Intervention arms: a) Ivermectin, single dose 600 μg/kg, for 5 days (I_600) and placebo (arm B) ; b) Ivermectin, single dose 1200 μg/kg, for 5 days (I_1200) (arm C) ); these drugs will be administered p.o. once daily, for 5 days.

In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

Patients will be randomized by a centralized computer system. At randomization a treatment ID is assigned to the patient. Once a treatment ID is assigned this must not be re-assigned even in cases of errors.

Enrolled subjects will be identified by a unique subject number (patient code) that will remain consistent for the duration of the study.

Patients will be recruited at the emergency room of hospitals, and/or among asymptomatic hospital workers found positive for SARS-CoV-2 at routine screening and/or in outpatient ambulatory settings, and/or at home, if not meeting the clinical criteria for hospitalization, according to the routine procedure of each participating site. The expected duration of subject inclusion in the study is of 1 month, or until the planned number of subjects to be enrolled will be reached.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I_600

ivermectin 600 μg/kg daily for 5 consecutive days (I\_600) + placebo

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Patients will be administered a single oral daily dose of approximately 600 μg/Kg (486-679 μg/Kg as rounded to a whole number of tablets), or 1200 μg/Kg (1098-1286 μg/Kg).

I_1200

ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Patients will be administered a single oral daily dose of approximately 600 μg/Kg (486-679 μg/Kg as rounded to a whole number of tablets), or 1200 μg/Kg (1098-1286 μg/Kg).

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients should take placebo orally on an empty stomach with water

Interventions

Ivermectin

Patients will be administered a single oral daily dose of approximately 600 μg/Kg (486-679 μg/Kg as rounded to a whole number of tablets), or 1200 μg/Kg (1098-1286 μg/Kg).

Intervention Type: DRUG

Placebo

Patients should take placebo orally on an empty stomach with water

Intervention Type: OTHER

Other Intervention Names

Ivermectin 9 mg cp by Chemo group; Placebo supplied by chemo group

Eligibility Criteria

Inclusion Criteria

• Age >=18 years
• Positivity at RT-PCR per SARS_CoV2 (nasopharyngeal swabs)
• Consent to participation to the study and to the processing of personal data
• COVID-19 Severity Score < 3
• Patient able to take oral drugs

Exclusion Criteria

• Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded)
• Subjects suffering from known CNS diseases
• Lack of (or inability to provide) informed consent
• Patient under dialysis
• Any severe medical condition with a prognosis of < 6 months
• Patients under warfarin treatment
• Patients under antiviral treatment
• Patients under chloroquine phosphate or hydroxychloroquine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeno Bisoffi

Role: PRINCIPAL_INVESTIGATOR

IRCCS Sacro Cuore Don Calabria hospital

Locations

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy

Policlinico S. Orsola

Bologna, , Italy

Ospedale Luigi Sacco

Milan, , Italy

Ospedale di Rovereto

Rovereto, , Italy

Ospedale Amedeo di Savoia

Turin, , Italy

Countries

Italy

Other Identifiers

cover_1

Identifier Type: -

Identifier Source: org_study_id