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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib for Hospitalized COVID-19 Patients
Phase 1
Waitlist Available
Led By Jennifer A Woyach, MD
Research Sponsored by Jennifer Woyach
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 to12 months
Awards & highlights
Study Summary
This trial is testing if ibrutinib can help treat symptoms of COVID-19 by reducing inflammation in the lungs and preserving overall immune function.
Who is the study for?
This trial is for hospitalized COVID-19 patients who can take pills and have a history or current diagnosis of cancer or conditions linked to immune suppression. They must not be on active anti-cancer therapy (except hormones), have serious heart issues, bleeding disorders, recent major surgery, uncontrolled infections, HIV/hepatitis B/C, need warfarin-like anticoagulants, or use strong CYP3A inhibitors.Check my eligibility
What is being tested?
The study is testing the safety and optimal dose of Ibrutinib in treating COVID-19 hospital patients. It aims to see if Ibrutinib can reduce lung inflammation without weakening the immune system overall, potentially decreasing ventilator dependency.See study design
What are the potential side effects?
Ibrutinib may cause side effects such as diarrhea, muscle pain, rash and bruising easily due to its effect on blood clotting. It might also lead to irregular heartbeat or infections because it affects the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death
Proportion of patients with diminished respiratory failure and death
Secondary outcome measures
At the end of therapy (day 14)
Duration of hospitalization
Incidence of any infection (viral, fungal, bacterial)
+11 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Mouth ulceration
5%
Onychomycosis
5%
Petechiae
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Haemorrhoids
4%
Vertigo
4%
Ecchymosis
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Abdominal distension
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Erythema
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Viral infection
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (ibrutinib)Experimental Treatment1 Intervention
Patients receive ibrutinib PO QD on days 1-7. Treatment repeats every 7 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who remain hospitalized or are re-admitted after 2 cycles may receive an additional 2 cycles per physician's discretion.
Group II: Arm B (usual care)Active Control1 Intervention
Patients receive usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,508 Total Patients Enrolled
Jennifer WoyachLead Sponsor
3 Previous Clinical Trials
91 Total Patients Enrolled
Jennifer A Woyach, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a stroke or bleeding in your brain recently.You are currently receiving cancer treatment, except for hormonal therapies.You have a known condition that makes you bleed easily.You have HIV, or have active hepatitis B or C infection.You need to take a blood thinner like warfarin.You have a serious stomach or intestine problem that affects how your body absorbs medicine.You have been hospitalized with a confirmed case of COVID-19.You have recently been diagnosed with cancer that needs immediate chemotherapy.You have a significant heart or blood vessel condition.You have a serious, uncontrolled infection.You have had cancer or a condition that makes your immune system weaker.Your total bilirubin level is not more than 1.5 times the normal limit, unless special circumstances apply.You are taking strong CYP3A inhibitors for a long time.Your liver enzymes (ALT and AST) are not more than three times the upper limit of normal.You are currently taking BTK inhibitor medication.Your blood counts are within normal range (white blood cells above 1000/mm^3, and platelets above 50,000/mm^3).You have signs of lung problems that meet certain criteria.Your kidneys are working well enough to clear waste from your body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (usual care)
- Group 2: Arm A (ibrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Ibrutinib attained regulatory certification for use?
"Although there is evidence of safety, the lack of efficacy data means that Ibrutinib only scored a 2 on our team's scale."
Answered by AI
Are more people being sought to participate in this medical experiment?
"At this time, the study is not seeking any more participants. The trial was posted on October 23rd 2020 and last modified on February 24th 2022. Should you be searching for other studies related to aplastic anemia there are currently 3878 trials with open participant recruitment slots; similarly, 155 clinical trials require volunteers for Ibrutinib research."
Answered by AI
How many participants are included in the scope of this research?
"Participants are no longer being accepted for this medical trial, which opened on October 23rd 2020 and was last edited on February 24th 2022. If you hope to join other studies related to aplastic anemia there are currently 3878 trials enlisted with 155 of those dedicated specifically to Ibrutinib therapy."
Answered by AI
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