Covid19 Clinical Trial
Official title:
Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
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
The study will be carried out in the province of Corrientes, in the Argentine Republic. All patients must be domiciled in this province. In the province of Corrientes, the care of patients with COVID19 is in charge of a single group of professionals (Crisis Committee) and patients who require hospitalization will be carried out in a single hospital destined for this purpose ;
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