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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447235
Recruitment Status : Terminated (futility analysis has demonstrated no difference between arms)
First Posted : June 25, 2020
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 25, 2020
Last Update Posted Date August 9, 2022
Actual Study Start Date  ICMJE July 23, 2020
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
Incidence of severe complications due COVID-19 infection [ Time Frame: 28 days ]
Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • Incidence of Severe Acute Respiratory Syndrome [ Time Frame: 28 days ]
    Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%
  • Incidence of Severe Acute Respiratory Syndrome [ Time Frame: 28 days ]
    Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
  • Adverse events [ Time Frame: 28 days ]
    Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)
  • Adverse events [ Time Frame: 28 days ]
    Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)
  • Adverse events [ Time Frame: 28 days ]
    Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)
  • Adverse events [ Time Frame: 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 [ Time Frame: 28 days ]
    Death of any cause since protocol enrollment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
Official Title  ICMJE Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
doubled-blind and placebo-controlled
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • COVID
  • Coronavirus Infection
Intervention  ICMJE
  • Drug: Placebo
    Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
  • Drug: Ivermectin
    Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
  • Drug: Losartan
    Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
Study Arms  ICMJE
  • Placebo Comparator: ARM A: 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.
    Intervention: Drug: Placebo
  • Experimental: ARM B: Ivermectin plus 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
    Interventions:
    • Drug: Ivermectin
    • Drug: Losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2022)
77
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2020)
176
Actual Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04447235
Other Study ID Numbers  ICMJE NP 1677/20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share individual participant data
Current Responsible Party Instituto do Cancer do Estado de São Paulo
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedro Exman, MD Instituto do Cancer do Estado de São Paulo
Study Director: Maria del Pilar Diz, MD, PhD Instituto do Cancer do Estado de São Paulo
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP