Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia

• Status: Withdrawn
• Trial end date: 2021-02-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Chloroquine; Chloroquine diphosphate; Losartan

Criteria

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.