Status:
WITHDRAWN
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects
Detailed Description
Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst ...
Eligibility Criteria
Inclusion
- Men or women ≥18 years.
- Oral tolerance or access for enteral administration of medication.
- PCR or IgM for SARS-CoV-2 positive.
- Negative pregnancy test in case of a woman of reproductive age.
- Signature of a document proving informed consent.
- Hospital admission for SARS-CoV-2 pneumonia.
Exclusion
- New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
- Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
- Known patient with hearing loss.
- Received chloroquine or hydroxychloroquine in the last 3 months.
- Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
- Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) \< 30ml/min 1.73 m2.
- Patients known to be deficient in 6-phosphate dehydrogenase
- Patients known to have retinopathy or macular disease.
- History of acute myocardial infarction in the last 6 months, unstable angina, ventricular tachycardia, ventricular fibrillation or class III-IV heart failure according to New York Heart Association.
- Electrocardiogram QTc interval ≥ 480 ms.
- Patients with hypomagnesemia or uncorrected hypokalemia.
- Patients with a history of psychiatric illness.
- Patients who are pregnant or nursing.
- Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
- Patients with acute pancreatitis.
- Patients who the investigators deem unsuitable for participation in the clinical trial.
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04428268
Start Date
March 10 2020
End Date
February 16 2021
Last Update
February 18 2021
Active Locations (1)
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1
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460