Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04438850 |
| Other study ID # |
cover_1 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2020 |
| Est. completion date |
June 8, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
IRCCS Sacro Cuore Don Calabria di Negrar |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 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 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
STUDY DESIGN
This is a multicentre, prospective, randomized, double-blind, adaptive phase II dose finding
study.
Patients meeting the inclusion criteria will be asked to participate to the study and
randomized in a 1:1:1 ratio to either:
- Placebo arm (arm A): placebo will be identical in appearance to ivermectin in order to
preserve blinding and will be administered p.o. at empty stomach with water once daily,
for 5 days
- Intervention arms: a) Ivermectin, single dose 600 μg/kg, for 5 days (I_600) and placebo
(arm B) ; b) Ivermectin, single dose 1200 μg/kg, for 5 days (I_1200) (arm C) ); these
drugs will be administered p.o. once daily, for 5 days.
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.
Patients will be randomized by a centralized computer system. At randomization a treatment ID
is assigned to the patient. Once a treatment ID is assigned this must not be re-assigned even
in cases of errors.
Enrolled subjects will be identified by a unique subject number (patient code) that will
remain consistent for the duration of the study.
Patients will be recruited at the emergency room of hospitals, and/or among asymptomatic
hospital workers found positive for SARS-CoV-2 at routine screening and/or in outpatient
ambulatory settings, and/or at home, if not meeting the clinical criteria for
hospitalization, according to the routine procedure of each participating site. The expected
duration of subject inclusion in the study is of 1 month, or until the planned number of
subjects to be enrolled will be reached.
