Pragmatic study CORIVER: Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID-19) - CORIVER

Carmen Hidalgo0 个研究点目标入组 45 人开始时间: 2020年7月22日最近更新: 2020年11月30日

试验速览

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•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

•Patients with Pneumonia due to SARS-COV2 that requires hospital admission, due to multilobar involvement, respiratory failure P02 <93% ambient air or <92% for COPD patients; with analytical criteria of severity (D-dimer> 600, CRP> 50, lymphopenia <900, ferritin> 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

发起方

Carmen Hidalgo