Status:
TERMINATED
COVidIVERmectin: Ivermectin for Treatment of Covid-19
Lead Sponsor:
IRCCS Sacro Cuore Don Calabria di Negrar
Collaborating Sponsors:
Istituto Di Ricerche Farmacologiche Mario Negri
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) iverme...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04438850
Start Date
July 31 2020
End Date
June 8 2021
Last Update
June 23 2021
Active Locations (5)
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1
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy, 37024
2
Policlinico S. Orsola
Bologna, Italy
3
Ospedale Luigi Sacco
Milan, Italy
4
Ospedale di Rovereto
Rovereto, Italy