COVidIVERmectin: Ivermectin for Treatment of Covid-19

• Status: Terminated
• Trial end date: 2021-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
• Collaborator: Istituto Di Ricerche Farmacologiche Mario Negri
• Treatments: Ivermectin

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