Ivermectin to Prevent Hospitalizations in COVID-19
Status:
Completed
Trial end date:
2021-02-22
Target enrollment:
Participant gender:
Summary
It is a single-center, prospective, randomized, double-blind, placebo-controlled study
carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in
coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet
all the inclusion criteria and none of the exclusion criteria are randomized via the web
system to receive placebo or ivermectin. The need for hospitalization in patients with
COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to
hospitalization (in days); use of invasive mechanical ventilation; time to invasive
mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ±
1 days and 12 ± 2 days after entering the study and ivermectin safety.
Intermediate internal analyzes of study objectives and serious adverse events will be
performed, including 125; 250 and 375 patients in order to assess the possible need for early
termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule
will be followed, therefore a value of p <0.001 will be considered significant