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

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 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 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).

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.

EXPANSION COHORT:

ARM III: Patients receive rintatolimod IV over 2.5-3 hours along with standard of care.

Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.