Clinical trial NCT04529525: Ivermectin to Prevent Hospitalizations in COVID-19
Official title: Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Ivermectin
Lead sponsor: Instituto de Cardiología de Corrientes
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age who reside in the province of Corrientes at the time of diagnosis;
* Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 hours;
* In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least one month before the time of inviting her to participate in this study);
* Weight at the time of inclusion greater than 48,000 kilograms;
* That they sign the informed consent for participation in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Known allergy to ivermectin or some of the components of ivermectin tablets or placebo;
* Current use of home oxygen;
* That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19;
* Presence of mal-absorptive syndrome;
* Presence of any other concomitant acute infectious disease;
* Known history of severe liver disease, for example liver cirrhosis;
* Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19;
* Need or use of hydroxychloroquine or chloroquine;
* Use of ivermectin up to 7 days prior to randomization;
* Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months;
* Current participation or in the last 30 days in a research study that has included the administration of a drug.

Primary outcomes:
measure: Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
timeFrame: through study completion, an average of 30 days
Secondary outcomes:
measure: Time to hospitalization
timeFrame: through study completion, an average of 30 days
measure: Percentage of Use of invasive mechanical ventilation support in each arm
timeFrame: through study completion, an average of 30 days
measure: Time to invasive mechanical ventilation support
timeFrame: through study completion, an average of 30 days
measure: Percentage of dialysis in each arm
timeFrame: through study completion, an average of 30 days
measure: All-cause mortality
timeFrame: through study completion, an average of 30 days
measure: Negative of the swab at 3±1 days and 12±2 days after entering the study
timeFrame: At days 3±1 and 12±2
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
timeFrame: through study completion, an average of 30 days
Other outcomes:
Locations:
city: Corrientes
country: Argentina
facility: Ministry of Public Health of the Province of Corrientes
Study officials:
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