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futility analysis has demonstrated no difference between arms
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Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Severe Acute Respiratory Syndrome | Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93% | 28 days |
| Incidence of Severe Acute Respiratory Syndrome | Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246-000 | Brazil |
no plan to share individual participant data
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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doubled-blind and placebo-controlled
| Ivermectin | Drug | Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients |
|
| Losartan | Drug | Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients |
|
| 28 days |
| Adverse events | Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L) | 28 days |
| Adverse events | Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL) | 28 days |
| Adverse events | Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL) | 28 days |
| 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 |
| Overall survival | Death of any cause since protocol enrollment | 28 days |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |