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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447235
Recruitment Status : Not yet recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Cancer COVID Coronavirus Infection Drug: Placebo Drug: Ivermectin Drug: Losartan Phase 2

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: doubled-blind and placebo-controlled
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021


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

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
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 :
  1. 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


Secondary Outcome Measures :
  1. Incidence of Severe Acute Respiratory Syndrome [ Time Frame: 28 days ]
    Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%

  2. Incidence of Severe Acute Respiratory Syndrome [ Time Frame: 28 days ]
    Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute

  3. Adverse events [ Time Frame: 28 days ]
    Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)

  4. Adverse events [ Time Frame: 28 days ]
    Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)

  5. 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)

  6. 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.

  7. Overall survival [ Time Frame: 28 days ]
    Death of any cause since protocol enrollment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447235


Contacts
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Contact: Pedro Exman, MD +5511991764565 drrpedroexman@gmail.com

Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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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
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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT04447235    
Other Study ID Numbers: NP 1677/20
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share individual participant data

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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
Keywords provided by Instituto do Cancer do Estado de São Paulo:
cancer
covid-19
losartan
ivermectin
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ivermectin
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Antiparasitic Agents
Anti-Infective Agents