SARS-COV2
Conditions
Interventions
Trade Name: Ivermectin
Product Name: Ivermectin
Product Code: Ivermectin
Pharmaceutical Form: Tablet
INN or Proposed INN: Ivermectin
Other descriptive name: IVERMECTIN
Concentration unit: µg/kg microg
Sponsors
Carmen Hidalgo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients over 50 years of age with comorbidities, diagnosed with SARS-Cov 2 infection by PCR or another diagnostic test performed in the emergency department, who are in the first week of clinic, without pneumonia and without admission criteria. • Patients between 18 and 70 years old (both inclusive) with pneumonia associated to SARS-Co2 infection: Cough or expectoration and / or fever> 38ºC + - Radiological infiltrate in Rxtórax; with SARS-Co2 PCR or radiological, clinical and analytical findings of COVID-19. • Evolution time of initial symptoms between 3 and 8 days. • Basal oxygen saturation> = 93% by breathing ambient air. • Have signed the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: • Patients with Pneumonia due to SARS-COV2 that requires hospital admission, due to multilobar involvement, respiratory failure P02 600, CRP> 50, lymphopenia 700 mg / dL, Il-6 or organ failure of the organ or who have significant comorbidities: Renal insufficiency> 3B; immunosuppression, cancer; chronic cirrhosis or liver disease, diabetes mellitus, atherosclerosis of any territory, heart rhythm disturbances (including prolonged QT), poorly controlled HT. • Patients with QT range > 500ms. • Patients under 18 years of age. • Chilg-Pugh C liver failure. • Impossibility of giving treatment for non-suppressible drugs with the risk of QT prolongation or interactions (antidepressants, antihistamines, quinolones, statins except pitavastatin) or allergy to the drug. • Taking any of the drugs in the trial within 7 days prior to inclusion in the study • Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of the use of Ivermectin in the treatment of SARS-COV2 ambulatory patients.;Secondary Objective: To analyze clinical parameters To evaluate the;Primary end point(s): Efficacy will be measured by comparing clinical cure, Microbiology, need for hospital admission due to clinical or analytical, blood gas and / or radiological deterioration for each arm.;Timepoint(s) of evaluation of this end point: Two weeks since the start of the tratment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): x;Timepoint(s) of evaluation of this end point: Two weeks since the start of the tratment | — |
Countries
Spain
Contacts
Public ContactSergio Sequera
Hospital Universitario Virgen de las Nieves
Outcome results
None listed