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

Cancer Clinical Trial

— TITAN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04447235
• Other study ID #: NP 1677/20
• Status: Terminated
• Phase: Phase 2
• Start date: July 23, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Coronavirus Infection
• Coronavirus Infections
• COVID
• COVID-19
• Infections

Intervention

Drug:
• Placebo
Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
• Ivermectin
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
• Losartan
Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	SAo Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Severe Acute Respiratory Syndrome	Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%	28 days
Secondary	Incidence of Severe Acute Respiratory Syndrome	Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute	28 days
Secondary	Adverse events	Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)	28 days
Secondary	Adverse events	Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)	28 days
Secondary	Adverse events	Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)	28 days
Secondary	Adverse events	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.	28 days
Secondary	Overall survival	Death of any cause since protocol enrollment	28 days