Clinical Trials Directory

Trials / Terminated

TerminatedNCT04379518

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

Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALRecombinant Interferon Alfa-2bGiven IV
DRUGRintatolimodGiven IV

Timeline

Start date
2020-11-17
Primary completion
2023-03-15
Completion
2023-03-15
First posted
2020-05-07
Last updated
2026-01-13
Results posted
2026-01-13

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04379518. Inclusion in this directory is not an endorsement.