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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Orally administered
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, Mexico
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.
Time frame: 28 days
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
Time frame: 28 days
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 frame: 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
Time frame: 28 days
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