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.
Drug: Placebo
Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
Drug: Ivermectin
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
Drug: Losartan
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
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
Instituto do Cancer do Estado de Sao Paulo
SAo Paulo, Brazil