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

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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 coronavirus disease 2019 (COVID-19). II. Determine the kinetics o...

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 coronavirus disease 2019 (COVID-19). II. Determine the kinetics of viral load in nasopharyngeal swabs in the course of treatment and days 7 and 14. SECONDARY OBJECTIVES: I. To assess the efficacy of the treatment combination in patients with cancer with mild or moderate COVID-19. II. Determine the kinetics of viral load in the peripheral blood in the course of treatment and days 7 and 14. III. 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 and days 7 and 14. IV. Determine the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R (PKR); oligoadenylate synthetase-2 (OAS2); RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats (IFIT1) and IFN-inducible transmembrane protein 3 (IFITM3), TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment. OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa-2b followed by a phase II study. LEAD-IN PHASE: Patients receive rintatolimod IV over 2.5-3 hours on day 1 and day 3 (or 4). Subsequent patients are randomized to 1 of 2 arms. ARM I: Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on day 1 and on day 3 or 4 in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard of care. EXPANSION COHORT: Patients are randomized to 1 of 2 arms. ARM III: Patients receive rintatolimod IV over 2.5-3 hours once. ARM IV: Patients receive standard of care. Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.

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