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
- Cancer
- Blood Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to 30 days post treatment intiation
Day 14
Inflammation
Day 14
Kinetics of viral load
Day 30
Clinical efficacy
Known mediators of antiviral immunity
Day 30
Incidence of adverse events (AEs)
Trial Safety
Phase-Based Safety
Side Effects for
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
90%Fatigue
80%Diarrhea
78%Palmar-plantar erythrodysesthesia syndrome
75%Anemia
73%Death
73%Aspartate aminotransferase increased
68%White blood cell decreased
65%Rash maculo-papular
60%Nausea
60%Proteinuria
57%Alanine aminotransferase increased
55%Dry skin
53%Platelet count decreased
53%Weight loss
53%Hypomagnesemia
53%Hypertriglyceridemia
50%Alopecia
50%Dyspnea
50%Hypophosphatemia
48%Hyperuricemia
45%Neutrophil count decreased
45%Mucositis oral
43%Hyperglycemia
35%Pain in extremity
35%Hypocalcemia
35%Peripheral sensory neuropathy
35%Vomiting
33%Back pain
30%Skin and subcutaneous tissue disorders - (Other)
30%Lymphocyte count decreased
28%Alkaline phosphatase increased
28%Blood bilirubin increased
28%Cough
25%Hypertension
25%Abdominal pain
25%Anorexia
25%Fever
20%Myalgia
20%Creatinine increased
20%Hyperkalemia
18%Arthralgia
18%Depression
18%Cholesterol high
18%Flatulence
18%Dysgeusia
15%Hypokalemia
15%Bone pain
15%Hypoalbuminemia
13%Headache
13%Blurred vision
13%Constipation
13%Pain
13%Injection site reaction
13%Lipase increased
10%Hyponatremia
10%Abdominal distension
10%Pruritus
10%Serum amylase increased
8%Allergic rhinitis
8%Hemorrhoids
8%Flu like symptoms
8%Infections and infestations - (Other)
8%Hypoglycemia
8%Non-cardiac chest pain
8%Syncope
8%Skin ulceration
8%Voice alteration
5%Arthritis
5%Chills
5%Dyspepsia
5%Edema limbs
5%Gastrointestinal disorders
5%Hypercalcemia
5%Hypotension
5%Vascular disorders - (Other)
3%Acidosis
3%Carbon monoxide diffusing capacity decreased
3%Joint range of motion decreased
3%Allergic reaction
3%Lipase Increased
3%Adrenal insufficiency
3%Agitation
3%Bronchospasm
3%Chest wall pain
3%Dehydration
3%Flushing
3%Gait disturbance
3%Glaucoma
3%Fracture
3%Erectile dysfunction
3%Eye pain
3%Eye disorders
3%Neck pain
3%Hemoglobinuria
3%Hyperhidrosis
3%Hypoxia
3%Memory impairment
3%Nervous system disorders - (Other)
3%Insomnia
3%Pelvic pain
3%Pain of skin
3%Pharyngolaryngeal pain
3%Respiratory, thoracic and mediastinal disorders - (Other)
3%Rectal pain
3%Toothache
3%Skin infection
3%Renal and urinary disorders - (Other)
3%Sinus tachycardia
3%Sore throat
3%Small intestinal obstruction
3%Stomach pain
3%Testicular pain
3%Tremor
3%Urinary frequency
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
Arm II/IV (standard of care)
1 of 3
Arm I (rintatolimod, recombinant interferon alfa-2b)
1 of 3
Arm III (rintatolimod)
1 of 3
Active Control
Experimental Treatment
64 Total Participants · 3 Treatment Groups
Primary Treatment: Recombinant Interferon Alfa-2b · No Placebo Group · Phase 1 & 2
Arm I (rintatolimod, recombinant interferon alfa-2b)Experimental Group · 2 Interventions: Recombinant Interferon Alfa-2b, Rintatolimod · Intervention Types: Biological, Drug
Arm III (rintatolimod)
Drug
Experimental Group · 1 Intervention: Rintatolimod · Intervention Types: DrugArm II/IV (standard of care)
Other
ActiveComparator Group · 1 Intervention: Best Practice · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon alfa-2b
FDA approved
Rintatolimod
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days post treatment intiation
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
384 Previous Clinical Trials
29,776 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,275 Previous Clinical Trials
41,234,627 Total Patients Enrolled
18 Trials studying COVID-19 Infection
77,522 Patients Enrolled for COVID-19 Infection
Brahm H SegalPrincipal InvestigatorRoswell Park Cancer Institute
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your doctors expect you to live for at least 6 more months, assuming you do not have COVID-19.
You have cancer or have received a stem cell transplant, with or without a cancer diagnosis.
Patients with any type of cancer, except for those with active acute leukemia and those who have had allogeneic hematopoietic stem cell transplants, may not participate in the trial. However, patients with early stage cancer or newly diagnosed cancer, such as myelodysplastic syndrome or chronic lymphocytic leukemia, may be eligible to participate. Skin cancers that have been treated with surgery do not count as cancer in this criterion.
You have undergone cancer treatment within the past 7 years or are currently receiving treatment.
If you had a type of skin cancer called basal cell carcinoma or a type of early cancer called carcinoma in situ, and it was removed with surgery alone, you cannot participate.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer