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

COVID-19 Pneumonia Clinical Trial

Official title:

Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04428268
• Other study ID #: IF20-00003
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 10, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: February 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 16, 2021
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Drug:
• Chloroquine Phosphate Tablets
Orally administered

Locations

Country	Name	City	State
Mexico	Hospital Universitario José E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	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.	28 days
Secondary	Clinical outcome assessment	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	28 days
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Assess the adverse events associated to chloroquine and chloroquine plus losartan at 28 days	28 days
Secondary	Time to negative SARS-CoV-2 test	Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result	28 days