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
- Conditions
- Severe acute respiratory syndrome SARSA00-B99
- Registration Number
- RBR-7hzhwd
- Lead Sponsor
- Hospital de Base de São José do Rio Preto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>
- Secondary Outcome Measures
Name Time Method