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

NCT04379518 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: I 659920NCI-2020-02317P30CA016056
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Symptomatic COVID-19 Infection Laboratory-Confirmed

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  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).

  Up to 30 days post treatment initiation, On average, the timeframe is 25 days

• Kinetics of Viral Load

  Will be assessed as cycle threshold values in nasopharyngeal swabs based on quantitative polymerase chain reaction (PCR) in the course of treatment and days 1, 3/4, 7, and 11.

  Treatment and days 1, 3/4, 7 and 11

Secondary Outcomes (22)

• Number of Participants With Selected Clinical Efficacy Complications

  Up to 30 days post treatment initiation

• Kinetics of Viral Load

  Days 1, 3, 7, 14 post treatment initiation

• Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)

  Days 1, 4 , 7, 14 and 30 post treatment initiation

• Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)

  Days 1, 4, 7, 14 and 30 post treatment

• Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)

  Days 1, 4, 7, 14, and 30 post treatment

Other Outcomes (1)

• Known Mediators of Antiviral Immunity

  Up to 30 days post treatment initiation

Study Arms (5)

Rintatolimod, recombinant interferon alfa-2b 0 MU/M^2

EXPERIMENTAL

Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.

Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod

Rintatolimod, recombinant interferon alfa-2b 5 MU/M^2

EXPERIMENTAL

Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.

Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod

Rrintatolimod plus Standard of Care)

EXPERIMENTAL

Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.

Drug: Rintatolimod

Rintatolimod, recombinant interferon alfa-2b 10 MU/M^2

EXPERIMENTAL

Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.

Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod

Rintatolimod, recombinant interferon alfa-2b 20 MU/M^2

EXPERIMENTAL

Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.

Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod

Interventions

Recombinant Interferon Alfa-2b BIOLOGICAL

Given IV

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, Interferon Alfa-2B, Interferon Alpha-2b, Intron A, Sch 30500, Urifron, Viraferon

Rintatolimod, recombinant interferon alfa-2b 0 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 10 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 20 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 5 MU/M^2

Rintatolimod DRUG

Given IV

Also known as: Ampligen, Atvogen

Rintatolimod, recombinant interferon alfa-2b 0 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 10 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 20 MU/M^2; Rintatolimod, recombinant interferon alfa-2b 5 MU/M^2; Rrintatolimod plus Standard of Care)

Eligibility Criteria

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

You may qualify if:

• Presence of symptomatic infection, defined by fever (temperature \[T\] \>= 38 degrees Celsius \[C\]) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infilitrates on chest X-ray or CT imaging. Diagnosis of COVID-19 is based on polymerase chain reaction (PCR) testing of respiratory samples.
• Age equal to \>= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children)
• Platelet \>= 75,000/uL
• Hemoglobin \>= 9 g/dL
• Hematocrit \>= 27%
• Absolute neutrophil count (ANC) \>= 1000/uL
• Creatinine clearance \>= 50 mL/min (Cockcroft-Gault Equation-note: plasma creatine instead of serum is used at Roswell Park)
• Total bilirubin =\< 2 X institutional upper limit of normal (ULN)
• Aspartate transaminase (AST) (plasma) and alanine transferase (ALT) (plasma) =\< 2 X institutional ULN
• Plasma amylase and lipase =\< 2 X institutional ULN
• In the absence of COVID-19, a life expectancy of 6 months is expected
• Participant 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
• EXPANSION COHORT: Patients with cancer or allogeneic stem cell transplant recipients with and without a cancer diagnosis
• Patients with cancer may be on active therapy or received therapy (e.g., chemotherapy, radiation or surgery) within 7 years

You may not qualify if:

• 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 (PaO2) \< 70 mm Hg, or partial pressure of oxygen in arterial blood (PaO2)-PaO2 (alveolar gas) \>= 35 mm Hg
• Contraindication to recombinant (r)-INFalpha based on prior hypersensitivity, autoimmune hepatitis, decompensated liver disease
• Cardiac events:
• Acute coronary syndrome, myocardial infarction, or ischemia within past 3 months
• New York Heart Association classification of III or IV congestive heart failure
• 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 make it difficult to evaluate clinical response to therapy or study drug toxicities
• Therapies known to cause cytokine release syndrome (CRS), e.g. engineered T cells, within 30 days
• Patients at high risk for tumor lysis syndrome
• Concurrent active pneumonitis predating COVID-19, such as from checkpoint inhibitor therapy, chemotherapy-associated toxicity, or radiation pneumonitis
• Autoimmune disease that requires systemic immunosuppression
• Protocol-defined baseline abnormalities in cell counts, renal, or hepatic function
• Any additional condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• AIM ImmunoTech Inc.: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Introns; Interferon alpha-2; poly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

igor.puzanov@roswellpark.org

716-845-2300

Study Officials

• Igor Puzanov

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 7, 2020
• Study Start: November 17, 2020
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-01

Locations

US (1)