COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04447235

Not reported

Not reported

2020-06-25

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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.

- 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

2

Instituto do Cancer do Estado de São Paulo

18

100

Brazil

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

77

Incidence of severe complications due COVID-19 infection

None

Phase 2

[{"arm_notes": "", "treatment_id": 1597, "treatment_name": "Ivermectin+losartan", "treatment_type": "Antiparasitics+cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]