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

NCT04447235 | Terminated Phase 2 DMC

• 1 other identifier: NP 1677/20
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; COVID; Coronavirus Infection

Keywords

cancer; covid-19; losartan; ivermectin

Outcome Measures

Primary Outcomes (1)

• Incidence of severe complications due COVID-19 infection

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

  28 days

Secondary Outcomes (7)

• Incidence of Severe Acute Respiratory Syndrome

  28 days

• Incidence of Severe Acute Respiratory Syndrome

  28 days

• Adverse events

  28 days

• Adverse events

  28 days

• Adverse events

  28 days

Study Arms (2)

ARM A: Placebo

PLACEBO COMPARATOR

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

ARM B: Ivermectin plus losartan

EXPERIMENTAL

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; Drug: Losartan

Interventions

Placebo DRUG

Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients

ARM A: Placebo

Ivermectin DRUG

Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients

ARM B: Ivermectin plus losartan

Losartan DRUG

Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients

ARM B: Ivermectin plus losartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Coronavirus Infections; COVID-19

Interventions

Ivermectin; Losartan

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Pedro Exman, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

• Maria del Pilar Diz, MD, PhD

  Instituto do Cancer do Estado de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: doubled-blind and placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: July 23, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)