Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Ivermectin; Losartan

Criteria

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