Clinical trial NCT04447235: Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
COVID
Coronavirus Infection
Keywords: cancer
covid-19
losartan
ivermectin
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of severe complications due COVID-19 infection
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of Severe Acute Respiratory Syndrome
timeFrame: 28 days
measure: Incidence of Severe Acute Respiratory Syndrome
timeFrame: 28 days
measure: Adverse events
timeFrame: 28 days
measure: Adverse events
timeFrame: 28 days
measure: Adverse events
timeFrame: 28 days
measure: Adverse events
timeFrame: 28 days
measure: Overall survival
timeFrame: 28 days
Other outcomes:
Locations:
city: SAo Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Pedro Exman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Cancer do Estado de São Paulo
name: Maria del Pilar Diz, MD, PhD
role: STUDY_DIRECTOR
References: