Randomized, Double-blind, Multi Centre Phase II, Dose Finding Clinical Trial on Ivermectin for the early Treatment of COVID-19

Phase 1

• Conditions: COVID-19; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002283-32-IT
• Lead Sponsor: OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

•Age (>=18 years)
•Positivity at RT-PCR per SARS_CoV-2 (nasopharyngeal swabs)
• COVID-19 Severity Score < 3
•Patient able to take oral drugs
•Informed consent to study participation and to personal data treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified