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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428268
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Adrian Camacho-Ortiz, 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

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Chloroquine Phosphate Tablets Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: investigator will not be aware of the treatments or outcomes until the end of the study
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : June 10, 2020
Estimated Study Completion Date : August 30, 2020


Arm Intervention/treatment
Active Comparator: Chloroquine
Patients will receive chloroquine phosphate 450 mg every 12 hours orally
Drug: Chloroquine Phosphate Tablets
Orally administered
Other Name: Losartan tablets

Experimental: Chloroquine plus losartan
Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs
Drug: Chloroquine Phosphate Tablets
Orally administered
Other Name: Losartan tablets




Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 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 :
  1. Clinical outcome assessment [ Time Frame: 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

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 28 days ]
    Assess the adverse events associated to chloroquine and chloroquine plus losartan at 28 days

  3. Time to negative SARS-CoV-2 test [ Time Frame: 28 days ]
    Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428268


Contacts
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Contact: Eduardo Pérez Alba, MD +52 8117998705 md.eduardo.perez@gmail.com
Contact: Laura Marina Nuzzolo Shihadeh, MD +52 8112773423 laura.nuzzolo@gmail.com

Locations
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Mexico
Hospital Universitario José E. Gonzalez Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Adrian Camacho, PhD    044 81 1263 5696    acamacho_md@yahoo.com   
Sub-Investigator: Eduardo Pérez Alba, MD         
Sub-Investigator: Laura Marina Nuzzolo Shihadeh, MD         
Principal Investigator: Adrian Camacho-Ortiz, PhD         
Sub-Investigator: Juan Diego Lecona García, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Adrian Camacho Ortiz, MD Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL
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Responsible Party: Dr. Adrian Camacho-Ortiz, Head of the Infectious Disease Department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04428268    
Other Study ID Numbers: IF20-00003
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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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
Keywords provided by Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez:
COVID-19
SARS-CoV-2 pneumonia
Chloroquine phosphate
Losartan
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Chloroquine
Chloroquine diphosphate
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics