Severe acute respiratory syndrome SARS
Conditions
Interventions
·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 ch
E02.319
Sponsors
Hospital de Base de São José do Rio Preto
Faculdade de Medicina de São Jose do Rio Preto FAMERP
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Suspected infections suggestive of fungal or bacterial etiologies. Chronic hepatitis C infection in antiviral therapy. Severely immunocompromised in the investigator's opinion (eg, differentiation cluster count 4+ [CD4 +] less than 200 cells / mm3, absolute neutrophil count less than 750 / mm3, first chemotherapy cycle completed within 2 weeks prior to screening, history stem cell transplantation within the period of 1 year prior to screening, any history of solid ORG transplant). Pregnant women, Category C Patients with a life expectancy of less than 30 days Patients with meningitis or other disorders of the Central Nervous System that may affect the blood-brain barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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;;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 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 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 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;;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 percentage of SARS-Cov-2 detection in oropharyngeal swab samples on day 5 after treatment;;Investigate the safety and tolerability of Ivermectin; | — |
Countries
Brazil
Contacts
Public ContactSuzana Lobo
Faculdade de Medicina de São José do Rio Preto - FAMERP
Outcome results
None listed