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
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 will remain blind to group allocation until after statistical analysis.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours
and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study
drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during
the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the
presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
Drug: Chloroquine Phosphate Tablets
Orally administered
Other Name: Losartan tablets
Inclusion Criteria:
1. Men or women ≥18 years.
2. Oral tolerance or access for enteral administration of medication.
3. PCR or IgM for SARS-CoV-2 positive.
4. Negative pregnancy test in case of a woman of reproductive age.
5. Signature of a document proving informed consent.
6. Hospital admission for SARS-CoV-2 pneumonia.
Exclusion Criteria:
1. New alteration of the state of alert that does not revert after interventions 60
minutes after hospital admission.
2. Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the
centre.
3. History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
4. Known patient with hearing loss.
5. Received chloroquine or hydroxychloroquine in the last 3 months.
6. Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine
transaminase (ALT) greater than three times the upper normal limit.
7. Patients with calculated glomerular filtration rate by Modification of Diet in Renal
Disease study equation (MDRD) < 30ml/min 1.73 m2.
8. Patients known to be deficient in 6-phosphate dehydrogenase
9. Patients known to have retinopathy or macular disease.
10. 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.
11. Electrocardiogram QTc interval ≥ 480 ms.
12. Patients with hypomagnesemia or uncorrected hypokalemia.
13. Patients with a history of psychiatric illness.
14. Patients who are pregnant or nursing.
15. Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride,
domperidone, atazanavir or lopinavir.
16. Patients with acute pancreatitis.
17. Patients who the investigators deem unsuitable for participation in the clinical
trial.
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo Leon, Mexico
Adrian Camacho Ortiz, MD, Principal Investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL