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

NCT04428268 | Withdrawn Phase 2

• 1 other identifier: IF20-00003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; SARS-CoV-2 pneumonia; Chloroquine phosphate; Losartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical outcome assessment

  28 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  28 days

• Time to negative SARS-CoV-2 test

  28 days

Study Arms (2)

Chloroquine

ACTIVE COMPARATOR

Patients will receive chloroquine phosphate 450 mg every 12 hours orally

Drug: Chloroquine Phosphate Tablets

Chloroquine plus losartan

EXPERIMENTAL

Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs

Drug: Chloroquine Phosphate Tablets

Interventions

Chloroquine Phosphate Tablets DRUG

Orally administered

Also known as: Losartan tablets

Chloroquine; Chloroquine plus losartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

chloroquine diphosphate; Losartan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Adrian Camacho Ortiz, MD

  Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: investigator will not be aware of the treatments or outcomes until the end of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Infectious Disease Department

Model Details: double blind randomized clinical trial

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: June 11, 2020
• Study Start: March 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: February 16, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

ME (1)