COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Ivermectina
Product Code: [-]
Pharmaceutical Form: Tablet
CAS Number: 70288-86-7
Current Sponsor code: -
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age (>=18 years) • Positivity at RT-PCR per SARS_CoV-2 (nasopharyngeal swabs) • COVID-19 Severity Score =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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;Primary end point(s): 1. Number of serious adverse drug reaction (SADR). 2. Quantitative viral load at Day 7 as measured by quantitative, digital droplet PCR. NB: The primary outcome no.2., as well as all secondary outcomes, will be measured only if the number of SADR is less than 4 in at least one of the treatment arms.;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Trend over time of quantitative viral load at Day 7, 14 and Day 30 as measured by quantitative, digital droplet PCR.; Time to clinical resolution (for symptomatic patients).; Proportion of patients with virological clearance at day 14 and 30; Rate of hospitalization.; COVID-19 Severity Score at Day 14 and Day 30;Timepoint(s) of evaluation of this end point: Day 7, 14 and 30; During the follow-up period; Day 14 and 30; During the follow-up period; Day 14 and 30 | — |
Countries
Italy, Spain
Contacts
Public ContactUnità per la Ricerca Clinica
IRCCS Sacro Cuore Don Calabria
Outcome results
None listed