Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19. The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan. We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
77
Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Incidence of severe complications due COVID-19 infection
Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
Time frame: 28 days
Incidence of Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%
Time frame: 28 days
Incidence of Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
Time frame: 28 days
Adverse events
Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)
Time frame: 28 days
Adverse events
Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)
Time frame: 28 days
Adverse events
Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)
Time frame: 28 days
Adverse events
Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of \> 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.
Time frame: 28 days
Overall survival
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Death of any cause since protocol enrollment
Time frame: 28 days