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

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04428268
Collaborator
(none)
0
1
2
11.3
0

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind randomized clinical trialdouble 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 :
Mar 10, 2020
Actual Primary Completion Date :
Jun 10, 2020
Actual Study Completion Date :
Feb 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Chloroquine

Patients will receive chloroquine phosphate 450 mg every 12 hours orally

Drug: Chloroquine Phosphate Tablets
Orally administered
Other Names:
  • 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 Names:
  • Losartan tablets
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario José E. Gonzalez Monterrey Nuevo Leon Mexico 64460

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    • Principal Investigator: Adrian Camacho Ortiz, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jun 11, 2020
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    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, Head of the Infectious Disease Department, Hospital Universitario Dr. Jose E. Gonzalez
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2021