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Interferon
Recombinant Interferon Alfa-2b for COVID-19 Infection
Phase 1 & 2
Waitlist Available
Led By Brahm H Segal
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post treatment intiation
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat cancer patients with COVID-19 infection. The drugs are designed to stimulate the immune system to limit the replication and spread of the virus.
Eligible Conditions
- Symptomatic COVID-19 Infection
- Blood Cancers
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post treatment intiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment intiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Clinical efficacy
Inflammation
Kinetics of viral load
Other outcome measures
Known mediators of antiviral immunity
Side effects data
From 2013 Phase 2 trial • 80 Patients • NCT0012659483%
Fatigue
83%
Diarrhea
80%
Palmar-plantar erythrodysesthesia syndrome
75%
Rash maculo-papular
68%
Dry skin
68%
Death
60%
Hyperuricemia
55%
Alopecia
55%
Aspartate aminotransferase increased
55%
Hyperglycemia
55%
Hypoglycemia
50%
Hypophosphatemia
50%
Hypertriglyceridemia
48%
Anemia
45%
Nausea
43%
Hypomagnesemia
40%
Dyspnea
40%
Hypertension
40%
Proteinuria
38%
Cholesterol high
38%
Weight loss
35%
Mucositis oral
33%
Alkaline phosphatase increased
30%
Pain in extremity
28%
Back pain
28%
Skin and subcutaneous tissue disorders - (Other)
28%
Vomiting
25%
Myalgia
25%
Creatinine increased
25%
Hyperkalemia
25%
Peripheral sensory neuropathy
25%
Hypokalemia
23%
Blood bilirubin increased
23%
Anorexia
20%
Pruritus
20%
Arthralgia
18%
Abdominal pain
18%
Fever
18%
Flatulence
18%
Pain
18%
Cough
18%
Alanine aminotransferase increased
15%
Bone pain
13%
Lipase increased
13%
Hyponatremia
13%
Infections and infestations - (Other)
10%
Edema limbs
10%
Hypoalbuminemia
10%
Lymphocyte count decreased
10%
Abdominal distension
10%
Constipation
10%
Dysgeusia
10%
Hyperhidrosis
8%
Serum amylase increased
8%
Depression
8%
Non-cardiac chest pain
8%
Erectile dysfunction
8%
Dyspepsia
8%
White blood cell decreased
8%
Blurred vision
8%
Headache
5%
Arthritis
5%
Dizziness
5%
Hemoglobinuria
5%
Respiratory, thoracic and mediastinal disorders - (Other)
5%
Bladder infection
5%
Gastritis
5%
Hypercalcemia
5%
Allergic rhinitis
5%
Hypocalcemia
5%
Neck pain
5%
Platelet count decreased
5%
Watering eyes
3%
Peripheral motor neuropathy
3%
Glaucoma
3%
Pancreatitis
3%
Stomach pain
3%
Appendicitis
3%
Epistaxis
3%
Bladder spasm
3%
Otitis media
3%
Pneumonitis
3%
Scrotal pain
3%
Conduction disorder
3%
Pleural effusion
3%
Eye pain
3%
Edema trunk
3%
Flushing
3%
Palpitations
3%
Gastrointestinal pain
3%
Oral pain
3%
Lung infection
3%
Supraventricular tachycardia
3%
Rash acneiform
3%
Renal and urinary disorders - (Other)
3%
Small intestinal obstruction
3%
Sinus pain
3%
Reproductive system and breast disorders - (Other)
3%
Upper respiratory infection
3%
Tinnitus
3%
Toothache
3%
Voice alteration
3%
Pharyngolaryngeal pain
3%
Gastrointestinal disorders
3%
Hypotension
3%
Hiccups
3%
Extraocular muscle paresis
3%
Eye disorders
3%
Myocardial infarction
3%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sorafenib Tosylate
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (rintatolimod)Experimental Treatment1 Intervention
Patients receive rintatolimod IV over 2.5-3 hours once.
Group II: Arm I (rintatolimod, recombinant interferon alfa-2b)Experimental Treatment2 Interventions
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.
Group III: Arm II/IV (standard of care)Active Control1 Intervention
Patients receive standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant Interferon Alfa-2b
2019
Completed Phase 2
~150
Rintatolimod
2019
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,794 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,603 Total Patients Enrolled
18 Trials studying COVID-19 Infection
77,456 Patients Enrolled for COVID-19 Infection
Brahm H SegalPrincipal InvestigatorRoswell Park Cancer Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main indications for Recombinant Interferon Alfa-2b?
"Interferon Alfa-2b, which is created through genetic engineering, can be used to treat kaposi sarcoma. In addition, this medication can also alleviate symptoms for patients suffering from anthracycline-based chemotherapy, lymphadenopathy, and melanoma."
Answered by AI
Are recruitment efforts for this trial still ongoing?
"The clinicaltrials.gov website verifies that this study, which was initially published on November 17th 2020, is still recruiting patients. In total, the trial needs 64 individuals from a single location."
Answered by AI
Are there other ongoing research projects that use Recombinant Interferon Alfa-2b?
"32 total studies are currently underway for recombinant interferon alfa-2b, 10 of which are in phase 3. Although many trials for this treatment are based in Buffalo, New york, there are 3428 locations running studies globally."
Answered by AI
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