Pragmatic study CORIVER: Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID19)

Phase 1

• Conditions: SARS-COV2; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001971-33-ES
• Lead Sponsor: Carmen Hidalgo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): x;Timepoint(s) of evaluation of this end point: Two weeks since the start of the tratment