Cancer, Coronavirus Infection, COVID
Conditions
Keywords
cancer, covid-19, losartan, ivermectin
Brief summary
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Detailed description
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.
Interventions
DRUGPlacebo
Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
DRUGIvermectin
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
DRUGLosartan
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
doubled-blind and placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years of age * Ability to understand and sign informed consent * Biopsy-proven diagnosis of previous cancer (solid or hematologic disease) * Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality. * Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan. * ECOG performance status 0 to 2 * Patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by: * Hemoglobin ≥ 9.0 g / dL * Leukometry\> 2,000 / mm3 * Absolute neutrophil count ≥ 1,500 / mm3 * Platelet count ≥ 100,000 / mm3 * Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula. * Total bilirubin \<3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome. * Aspartate aminotransaminase (AST) \<3.0 x LSN. * Alanine aminotransaminase (ALT) \<3.0 x ULN.
Exclusion criteria
* Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB). * Patients who presents with severe conditions at the time of diagnosis requiring ICU admission. * Prior reaction or intolerance to an ARB or ACE inhibitor. * Blood pressure less than 110/70 mmHg at presentation * Potassium greater than 5.0 mEq / L * Pregnancy or breastfeeding * Prior reaction to Ivermectin. * Patient currently enrolled in another research protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe complications due COVID-19 infection | 28 days | Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Acute Respiratory Syndrome | 28 days | Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93% |
| Adverse events | 28 days | Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L) |
| Overall survival | 28 days | Death of any cause since protocol enrollment |
Countries
Brazil
Outcome results
None listed