Status:
TERMINATED
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Cancer
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 diagno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04447235
Start Date
July 23 2020
End Date
June 30 2022
Last Update
August 9 2022
Active Locations (1)
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1
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246-000