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Terminated
futility analysis has demonstrated no difference between arms

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

ClinicalTrials.gov ID NCT04447235
Sponsor Instituto do Cancer do Estado de São Paulo
Information provided by Instituto do Cancer do Estado de São Paulo (Responsible Party)
Last Update Posted 2022-08-09
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Study Overview

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.

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Official Title
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
Conditions
Cancer
COVID
Coronavirus Infection
Intervention / Treatment
  • Drug: Placebo
  • Drug: Ivermectin
  • Drug: Losartan
  • Drug: Placebo
  • Drug: Ivermectin
  • Drug: Losartan
Other Study ID Numbers
  • NP 1677/20
Study Start (Actual)
2020-07-23
Primary Completion (Actual)
2022-06-30
Study Completion (Actual)
2022-06-30
Enrollment (Actual)
77
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Double (ParticipantCare Provider)
Masking Description: doubled-blind and placebo-controlled

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm 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/Treatment Drug: Placebo
  • Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients

Participant Group/Arm 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
Intervention/Treatment 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

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Incidence of severe complications due COVID-19 infectionIncidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death28 days
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Incidence of Severe Acute Respiratory SyndromeSevere Acute Respiratory Syndrome defined as oxygen saturation less than 93%28 days
Incidence of Severe Acute Respiratory SyndromeSevere Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute28 days
Adverse eventsIncidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)28 days
Adverse eventsIncidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)28 days
Adverse eventsIncidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)28 days
Adverse eventsIncidence 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.28 days
Overall survivalDeath of any cause since protocol enrollment28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Instituto do Cancer do Estado de São Paulo
Investigators
  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-06-22
First Submitted that Met QC Criteria
2020-06-23
First Posted
2020-06-25
Study Record Updates
Last Update Submitted that met QC Criteria
2022-08-05
Last Update Posted
2022-08-09
Last Verified
2022-08

More Information

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Keywords Provided by Instituto do Cancer do Estado de São Paulo
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
no plan to share individual participant data