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Rintatolimod and IFN Alpha-2b for the Treatment of Mild or Moderate COVID-19 Infection in Cancer Patients

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ClinicalTrials.gov Identifier: NCT04379518
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm SARS Coronavirus 2 Infection Biological: Recombinant Interferon Alfa-2b Drug: Rintatolimod Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety of the combination of intravenous (i.v.) rintatolimod administered with or without i.v. IFN alpha (recombinant interferon alfa-2b [intron A]) in patients with cancer with mild or moderate COVID-19.

II. To determine the rate of the following complications of COVID-19: (i) progression of infection requiring hospitalization; (ii) acute respiratory distress syndrome (ARDS); (iii) and 30-day mortality.

SECONDARY OBJECTIVES:

I. Determine the kinetics of viral load in the peripheral blood and nasal swabs in the course of treatment.

II. Determine the kinetics of changes of the immune subsets and circulating inflammatory mediators (including C-reactive protein [CRP], cytokines, chemokines, interferons) in peripheral blood in the course of treatment.

OUTLINE: This is a dose-escalation study of recombinant interferon alfa-2b.

Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on days 1, 3, 5, and 8 in the absence of disease progression or unacceptable toxicity.

Patients are followed up at days 14 and 28 after initiation of the study regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection
Estimated Study Start Date : May 30, 2020
Estimated Primary Completion Date : April 6, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportve Care (rintatolimod, recombinant interferon alpha-2b)
Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on days 1, 3, 5 and 8 in the absence of disease progression or unacceptable toxicity.
Biological: Recombinant Interferon Alfa-2b
Given IV
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Interferon alfa 2b
  • Interferon Alfa-2B
  • Interferon Alpha-2b
  • Intron A
  • Sch 30500
  • Urifron
  • Viraferon

Drug: Rintatolimod
Given IV
Other Names:
  • Ampligen
  • Atvogen




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 30 days post treatment intiation ]
    This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).

  2. Reduction of progression of infection requiring hospitalization [ Time Frame: Up to 30 days post treatment initiation ]
  3. Reduction of acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post treatment initiation ]
    ARDS will be defined by Berlin criteria.

  4. 30-day mortality [ Time Frame: At 30 days post treatment initiation ]
    The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.


Secondary Outcome Measures :
  1. Kinetics of viral load in the peripheral blood and nasal swabs [ Time Frame: During the course of treatment up to day 28 ]
    Will be analyzed using quantitative polymerase chain reaction (PCR).

  2. Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood [ Time Frame: During the course of treatment up to day 28 ]
    The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.


Other Outcome Measures:
  1. ARDS severity [ Time Frame: Up to 30 days post treatment initiation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Patients with cancer on active therapy or with therapy (e.g., chemotherapy, radiation or surgery) within 6 months. Basal cell cancer and carcinoma in situ treated with local excision alone do not qualify for inclusion
  • Presence of mild or moderate symptomatic infection, defined by fever (temperature [T] > 38 celsius [C]) OR respiratory symptoms (cough, nasal congestion, or shortness of breath). Severe infection is excluded (see exclusion criteria). Diagnosis of COVID-19 is based on polymerase chain reaction (PCR) testing of respiratory samples
  • Platelet >= 75,000/uL
  • Hemoglobin >= 9 g/dL
  • Hematocrit >= 27%
  • Absolute neutrophil count (ANC) >= 1000/uL
  • Creatinine clearance >= 50 mL/min
  • Total bilirubin =< 2 X institutional upper limit of normal (ULN)
  • Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine transferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 X institutional ULN
  • Serum amylase and lipase =< 2 X institutional ULN
  • In the absence of COVID-19, a life expectancy of at least 6 months is expected
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • NOTE: For blood Chemistry labs, Roswell Park clinical blood chemistries are performed on plasma unless otherwise indicated

Exclusion Criteria:

  • Patients with severe COVID-19 infection defined by pulmonary infiltrates on chest x-ray or computed tomography (CT) imaging plus one of the following: room air oxygen saturation (SaO2) =< 92%, room air partial pressure of oxygen (PO2) < 70 mm Hg, or partial pressure of oxygen in arterial blood (PAO2)-PaO2 (alveolar gas) >= 35 mm Hg
  • Patients who are inpatients or require hospitalization at the time of diagnosis of COVID-19
  • Contraindication to interferon based on the package insert: prior hypersensitivity to interferon-alpha formulations, autoimmune hepatitis, decompensated liver disease
  • Cardiac risk factors including:

    • Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within past 3 months
    • Patients with a New York Heart Association classification of III or IV
  • Unwilling or unable to follow protocol requirements
  • Patients with known serious mood disorders
  • Any additional condition, such as pre-existing inflammatory lung disease, which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
  • Concurrent infections, e.g. bacterial pneumonia or sepsis, that would preclude evaluation of the efficacy or safety of the study regimen
  • Patients receiving the following therapies within the past 30 days that are known to cause cytokine release syndrome (CRS): chimeric antigen receptor (CAR)-T cells and other engineered T cells and bispecific antibodies such as blinatumomab. Decisions about excluding patients based on risk for CRS will be made after discussion with the primary oncologist
  • Patients at high risk for tumor lysis syndrome, such as induction/reinduction therapy for acute leukemia and initial therapy for lymphoma with bulky disease. Decisions about excluding patients at risk for tumor lysis syndrome will be made after discussion with the primary oncologist
  • Concurrent active pneumonitis predating COVID-19, such as from checkpoint inhibitor therapy, chemotherapy-associated toxicity, or radiation pneumonitis
  • Any additional condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive the study drugs

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): NCT04379518


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Contact: Brahm H. Segal    716-845-5721    brahm.segal@roswellpark.org   
Principal Investigator: Brahm H. Segal         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brahm H Segal Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04379518    
Other Study ID Numbers: I 659920
NCI-2020-02317 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 659920 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Neoplasms
Interferons
Interferon-alpha
Interferon alpha-2
poly(I).poly(c12,U)
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs