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
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm SARS Coronavirus 2 Infection||Biological: Recombinant Interferon Alfa-2b Drug: Rintatolimod||Phase 1 Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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
- 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).
- Reduction of progression of infection requiring hospitalization [ Time Frame: Up to 30 days post treatment initiation ]
- Reduction of acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post treatment initiation ]ARDS will be defined by Berlin criteria.
- 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.
- 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).
- 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.
- ARDS severity [ Time Frame: Up to 30 days post treatment initiation ]
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
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Contact: Brahm H. Segal 716-845-5721 firstname.lastname@example.org|
|Principal Investigator: Brahm H. Segal|
|Principal Investigator:||Brahm H Segal||Roswell Park Cancer Institute|