Back to resultsChloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
Primary Purpose
COVID-19 Pneumonia
Status
Withdrawn
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Chloroquine Phosphate Tablets
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, SARS-CoV-2 pneumonia, Chloroquine phosphate, Losartan
Eligibility Criteria
Inclusion Criteria:
- Men or women ≥18 years.
- Oral tolerance or access for enteral administration of medication.
- PCR or IgM for SARS-CoV-2 positive.
- Negative pregnancy test in case of a woman of reproductive age.
- Signature of a document proving informed consent.
- Hospital admission for SARS-CoV-2 pneumonia.
Exclusion Criteria:
- New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
- Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
- Known patient with hearing loss.
- Received chloroquine or hydroxychloroquine in the last 3 months.
- Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
- Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) < 30ml/min 1.73 m2.
- Patients known to be deficient in 6-phosphate dehydrogenase
- Patients known to have retinopathy or macular disease.
- 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.
- Electrocardiogram QTc interval ≥ 480 ms.
- Patients with hypomagnesemia or uncorrected hypokalemia.
- Patients with a history of psychiatric illness.
- Patients who are pregnant or nursing.
- Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
- Patients with acute pancreatitis.
- Patients who the investigators deem unsuitable for participation in the clinical trial.
Sites / Locations
- Hospital Universitario José E. Gonzalez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chloroquine
Chloroquine plus losartan
Arm Description
Patients will receive chloroquine phosphate 450 mg every 12 hours orally
Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Time to negative SARS-CoV-2 test
Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result
Full Information
NCT ID
NCT04428268
First Posted
April 26, 2020
Last Updated
February 16, 2021
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT04428268
Brief Title
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
evidence showed chloroquine is not effective against COVID-19
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
February 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
COVID-19, SARS-CoV-2 pneumonia, Chloroquine phosphate, Losartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized clinical trial
Masking
InvestigatorOutcomes Assessor
Masking Description
investigator will not be aware of the treatments or outcomes until the end of the study
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloroquine
Arm Type
Active Comparator
Arm Description
Patients will receive chloroquine phosphate 450 mg every 12 hours orally
Arm Title
Chloroquine plus losartan
Arm Type
Experimental
Arm Description
Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs
Intervention Type
Drug
Intervention Name(s)
Chloroquine Phosphate Tablets
Other Intervention Name(s)
Losartan tablets
Intervention Description
Orally administered
Primary Outcome Measure Information:
Title
Overall mortality
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinical outcome assessment
Description
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 Frame
28 days
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Assess the adverse events associated to chloroquine and chloroquine plus losartan at 28 days
Time Frame
28 days
Title
Time to negative SARS-CoV-2 test
Description
Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women ≥18 years.
Oral tolerance or access for enteral administration of medication.
PCR or IgM for SARS-CoV-2 positive.
Negative pregnancy test in case of a woman of reproductive age.
Signature of a document proving informed consent.
Hospital admission for SARS-CoV-2 pneumonia.
Exclusion Criteria:
New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
Known patient with hearing loss.
Received chloroquine or hydroxychloroquine in the last 3 months.
Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) < 30ml/min 1.73 m2.
Patients known to be deficient in 6-phosphate dehydrogenase
Patients known to have retinopathy or macular disease.
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.
Electrocardiogram QTc interval ≥ 480 ms.
Patients with hypomagnesemia or uncorrected hypokalemia.
Patients with a history of psychiatric illness.
Patients who are pregnant or nursing.
Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
Patients with acute pancreatitis.
Patients who the investigators deem unsuitable for participation in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Camacho Ortiz, MD
Organizational Affiliation
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario José E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
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