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

Phase 2

Withdrawn

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: Chloroquine Phosphate Tablets

• Registration Number: NCT04428268
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-04-26
• Primary Completion: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Status Verified: 2021-02
• Study Completion: 2021-02-16
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroquine	Chloroquine Phosphate Tablets	Patients will receive chloroquine phosphate 450 mg every 12 hours orally
Chloroquine plus losartan	Chloroquine Phosphate Tablets	Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs

Primary Outcome Measures

Name	Time	Method
Overall mortality	28 days	Determine all-cause mortality up to 28 days after randomization of Chloroquine Phosphate Compared to Chloroquine Phosphate plus Losartan in Non-Critically Ill Patients with SARS-CoV-2 Pneumonia.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	28 days	Assess the adverse events associated to chloroquine and chloroquine plus losartan at 28 days
Clinical outcome assessment	28 days	Compare the clinical outcome of Chloroquine Phosphate treatment vs Chloroquine Phosphate plus Losartan in the follow-up visit at the end of treatment. Acording to NIH and FDA definitions
Time to negative SARS-CoV-2 test	28 days	Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result

Trial Locations

Locations (1)

Hospital Universitario José E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico