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

Phase 2

Terminated

• Conditions: Cancer; COVID; Coronavirus Infection
• Interventions: Drug: Placebo; Drug: Ivermectin; Drug: Losartan

• Registration Number: NCT04447235
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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 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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Study Start: 2020-07-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM B: Ivermectin plus losartan	Losartan	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
ARM A: Placebo	Placebo	Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.
ARM B: Ivermectin plus losartan	Ivermectin	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

Primary Outcome Measures

Name	Time	Method
Incidence of severe complications due COVID-19 infection	28 days	Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death

Secondary Outcome Measures

Name	Time	Method
Incidence of Severe Acute Respiratory Syndrome	28 days	Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
Adverse events	28 days	Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of \> 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.
Overall survival	28 days	Death of any cause since protocol enrollment

Trial Locations

Locations (1)

Instituto do Cancer do Estado de Sao Paulo; 🇧🇷 SAo Paulo, Brazil