A clinical, double-blind, randomized study to assess the effects and safety of Ivermectin in patients with Severe Acute Respiratory Syndrome during the Covid-19 pandemic

INTERVENTION: ·Intervention Group: A group of 283 patients will receive Ivermectin 400mcg/kg/day for 3 consecutive days, single dose, Oral and standard treatment standardized by the institution, which will be in charge of the physician on duty and include amoxicillin / clavulanate (100mg/kg/day ) divided into 3 taken by IV, azithromycin 500mg once a day by IV or VO (if spontaneous), oseltamivir, 75 mg every 12hrs by NS or orally. ·Placebo group: A group of 283 patients will receive placebo (microcrystalline cellulose) 400mcg/kg/day for 3 consecutive days for 3 consecutive days a single dose Oral and standard treatment standardized by the institution, which will be in charge of the doctor on duty and include amoxicillin / clavulanate (100mg/ kg/day) divided into 3 taken IV, azithromycin 500mg once a day IV or VO (if spontaneous), oseltamivir, 75 mg every 12hrs by SEN or orally. Standard treatment: amoxacillin / clavulanate (100mg / kg / day) divided into 3 doses taken by EV, azithromycin 500mg once daily via EV or VO (if spontaneous), oseltamivir 75 mg every 12hrs by SNE or orally. E02.319 CONDITION: A00‐B99 Severe acute respiratory syndrome SARS PRIMARY OUTCOME: Investigate the proportion of patients with COVID‐19 who progress to ICU admission by comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment; SECONDARY OUTCOME: Evaluate the proportion of outpatients on day 28 in the Ivermectin treatment group by comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment Investigate all‐cause mortality at 28 days in the Ivermectin treatment group in combination with standard treatment compared to the placebo and standard treatment group; Investigate percentage of SARS‐Cov‐2 detection in oropharyngeal swab samples on day 5 after treatment; Investigate the incidence and duration of antibiotic treatment in the Ivermectin treatment group, comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment; Investigate the proportion of patients who evolve to mechanical ventilatory support by comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment Investigate the safety and tolerability of Ivermectin; Investigate the time until the improvement of the respiratory condition by comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment Investigate whether Ivermectin is able to reduce organ dysfunction assessed by significant improvement in the SOFA score by comparing the Ivermectin groups in combination with standard treatment and placebo in combination with standard treatment; INCLUSION CRITERIA: Men or women, 18 years of age or older, ability to provide informed consent signed by study patient or legally acceptable representative Respiratory sign or symptom, cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, O2 saturation less than 93%, signs of cyanosis, nasal flaring, accessory muscle use, and dyspnea). Need for oxygen support using a nasal catheter up to 6 l / min to keep SaO2 above 94% or SpO2 less than 94% in room air. Proven diagnosis of Covid‐19 using a molecular diagnostic assay based on polymerase chain reaction. Requires hospitalization in the ward. Less than seven days after the first flu‐like symptom.