COVidIVERmectin: Ivermectin for Treatment of Covid-19

NCT04438850 | Terminated Phase 2 DMC

• 1 other identifier: cover_1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

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.

Conditions

Covid19

Keywords

ivermectin

Outcome Measures

Primary Outcomes (2)

• SADR

  Number of serious adverse drug reaction

  14 days

• Viral load

  Quantitative viral load as measured by quantitative, digital droplet PCR.

  Assessed at day 7

Secondary Outcomes (6)

• Trend viral load

  Days 7 and 14 from baseline

• Clinical resolution

  Assessed on Day 30

• Viral clearance

  assessed on days 14 and 30

• Virological clearance

  Assessed at day 14 and 30

• hospitalization rate

  Day 30

Study Arms (3)

I_600

EXPERIMENTAL

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

Drug: Ivermectin

I_1200

EXPERIMENTAL

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

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Ivermectin 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).

Also known as: Ivermectin 9 mg cp by Chemo group

I_1200; I_600

Placebo OTHER

Patients should take placebo orally on an empty stomach with water

Also known as: Placebo supplied by chemo group

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (5)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

Location

Policlinico S. Orsola

Bologna, Italy

Location

Ospedale Luigi Sacco

Milan, Italy

Location

Ospedale di Rovereto

Rovereto, Italy

Location

Ospedale Amedeo di Savoia

Turin, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Zeno Bisoffi

  IRCCS Sacro Cuore Don Calabria hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ivermectin and placebo treatment will be double blinded, i.e. the treatment will be unknown to both the subject and the treating physician. The hospital pharmacist will be unblinded to study treatment because in charge to prepare the study treatment according to randomization arm.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: June 19, 2020
• Study Start: July 31, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The database will be available upon publication of the results
• Access Criteria: The data will be available in a public repository

Locations

IT (5)