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

Instituto do Cancer do Estado de São Paulo

Status and phase: Terminated; Phase 2

Conditions: COVID; Cancer; Coronavirus Infection

Treatments: Drug: Placebo; Drug: Ivermectin; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT04447235

NP 1677/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups, including a placebo group

ARM A: Placebo

Placebo Comparator group

Description:

Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.

Treatment:

Drug: Placebo

ARM B: Ivermectin plus losartan

Experimental group

Description:

Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days

Treatment:

Drug: Losartan

Drug: Ivermectin