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

NCT ID: NCT04428268

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2021-02-16

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 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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chloroquine

Patients will receive chloroquine phosphate 450 mg every 12 hours orally

Group Type: ACTIVE_COMPARATOR

Chloroquine Phosphate Tablets

Intervention Type: DRUG

Orally administered

Chloroquine plus losartan

Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs

Group Type: EXPERIMENTAL

Chloroquine Phosphate Tablets

Intervention Type: DRUG

Orally administered

Interventions

Chloroquine Phosphate Tablets

Orally administered

Intervention Type: DRUG

Other Intervention Names

Losartan tablets

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

Dr. Adrian Camacho-Ortiz

Head of the Infectious Disease Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Camacho Ortiz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL

Locations

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

IF20-00003

Identifier Type: -

Identifier Source: org_study_id