NCT04382586
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Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants |
Completed |
Phase 2 |
Jul/06/2020 |
Feb/01/2021 |
- Alternative id - BGB-3111-219
- Interventions - Drug: Zanubrutinib|Drug: Supportive Care|Drug: Placebo
- Study type - Interventional
- Study results - Has Results
- Locations - Honor Health, Scottsdale, Arizona, United States|St. Jude Medical Center, Fullerton, California, United States|Olive View - UCLA Medical Center, Sylmar, California, United States|MedStar Heath Research Institute/ MedStar Washington Hospital Center, Washington, District of Columbia, United States|Augusta University, Augusta, Georgia, United States|John D. Archbold Memorial Hospital, Thomasville, Georgia, United States|Loyola University Medical Center, Maywood, Illinois, United States|SIU School of Medicine, Springfield, Illinois, United States|University of Iowa, Iowa City, Iowa, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|Brigham And Women's Hospital, Boston, Massachusetts, United States|Morristown Medical Center, Morristown, New Jersey, United States|Rutgers University Hospital, Newark, New Jersey, United States|Atlantic Health System, Inc. / Chilton Medical Center, Pompton Plains, New Jersey, United States|Overlook Medical Center, Summit, New Jersey, United States|Therapeutic Concepts, Houston, Texas, United States|Covenant Health System, Lubbock, Texas, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 63
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of Participants With Respiratory Failure-free Survival|Time to Breathing Room Air|Number of Participants Experiencing Respiratory Failure or Death|Number of Participants With All-cause Mortality|Number of Participants Discharged Alive|Number of Participants Discharged Alive From the ICU|Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale|Duration of Mechanical Ventilation|Duration of Hospitalization|PaO2:FiO2 Ratio|Number of Participants With Adverse Events
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NCT04346199
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Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. |
Completed |
Phase 2 |
Jun/12/2020 |
Nov/17/2020 |
- Alternative id - D822FC00001
- Interventions - Drug: Acalabrutinib
- Study type - Interventional
- Study results - Has Results
- Locations - Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Monte Grande, Argentina|Research Site, Ramos Mejía, Argentina|Research Site, Botucatu, Brazil|Research Site, Brasillia, Brazil|Research Site, Florianópolis, Brazil|Research Site, Porto Alegre, Brazil|Research Site, Porto Alegre, Brazil|Research Site, Ribeirão Preto, Brazil|Research Site, Salvador, Brazil|Research Site, Sao Bernardo do Campo, Brazil|Research Site, Sao Paulo, Brazil|Research Site, Sao Paulo, Brazil|Research Site, São Paulo, Brazil|Research Site, Curico, Chile|Research Site, Santiago, Chile|Research Site, Talca, Chile|Research Site, Villejuif Cedex, France|Research Site, Frankfurt, Germany|Research Site, Gauting, Germany|Research Site, Köln, Germany|Research Site, Bangalore, India|Research Site, New Delhi, India|Research Site, Milano, Italy|Research Site, Roma, Italy|Research Site, Shinjuku-ku, Japan|Research Site, D.F, Mexico|Research Site, Monterrey, Mexico|Research Site, México, Mexico|Research Site, Lima, Peru|Research Site, Lima, Peru|Research Site, Lima, Peru|Research Site, Warszawa, Poland|Research Site, Warszawa, Poland|Research Site, Moscow, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Murmansk, Russian Federation|Research Site, Cape Town, South Africa|Research Site, George, South Africa|Research Site, Johannesburg, South Africa|Research Site, Johannesburg, South Africa|Research Site, Pretoria, South Africa|Research Site, Ankara, Turkey|Research Site, Bakirkoy, Turkey|Research Site, Istanbul, Turkey|Research Site, Istanbul, Turkey|Research Site, Umraniye, Turkey
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 177
- Age - 18 Years to 130 Years (Adult, Older Adult)
- Outcome measures - Percentage of Participants Alive and Free of Respiratory Failure at Day 14|Number of Participants With Adverse Events and Serious Adverse Events|Percentage of Participants Alive and Free of Respiratory Failure at Day 28|Percent Change From Baseline in C-reactive Protein.|Percent Change From Baseline in Ferritin|Percent Change From Baseline in Absolute Lymphocyte Count|Overall Survival|Percentage of Participants Alive and Discharged From ICU|Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause|Number of Days Alive and Free of Respiratory Failure|Number of Days With Respiratory Failure|Number of Days Hospitalized|Number of Days in ICU|Number of Days Alive Outside of Hospital|Percent Change From Baseline in Oxygenation Index|Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale|Pharmacokinetics of Acalabrutinib|Pharmacokinetics of ACP-5862
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NCT04497948
|
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 |
Terminated |
Phase 1 |
Sep/21/2020 |
Nov/18/2020 |
- Alternative id - D822FC00005
- Interventions - Drug: Acalabrutinib
- Study type - Interventional
- Study results - Has Results
- Locations - Research Site, Porto Alegre, Brazil|Research Site, Ribeirão Preto, Brazil|Research Site, Sao Paulo, Brazil|Research Site, Sao Paulo, Brazil
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 9
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Area Under the Concentration-time Curve From 0 to 12 Hours (AUC12h) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5)|Area Under the Concentration-time Curve From 0 to Time to Last Quantifiable Concentration (AUClast) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5)|Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5)
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NCT04647669
|
World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments |
Not yet recruiting |
Phase 3 |
Jun/01/2021 |
Dec/31/2021 |
- Alternative id - SRD/ETH/20
- Interventions - Drug: Remdesivir|Drug: Acalabrutinib|Drug: Interferon beta-1a|Other: Standard of Care
- Study type - Interventional
- Study results - No Results Available
- Locations - Univeristy of the West Indies, Kingston, Jamaica
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - All cause Mortality|Duration of hospital stay|Time to first receiving ventilation|Time to admission to the intensive care unit
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NCT04564040
|
A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole |
Completed |
Phase 1 |
Oct/12/2020 |
Dec/11/2020 |
- Alternative id - D8223C00005
- Interventions - Drug: Acalabrutinib Treatment A|Drug: Acalabrutinib Treatment B|Drug: Acalabrutinib Treatment C|Drug: Acalabrutinib Treatment D
- Study type - Interventional
- Study results - No Results Available
- Locations - Research Site, Berlin, Germany
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 20
- Age - 18 Years to 55 Years (Adult)
- Outcome measures - Part 1 and 2: Area under plasma concentration-time curve from time zero to infinity (AUCinf)|Part 1 and 2: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUClast)|Part 1 and Part 2: Maximum observed plasma concentration (Cmax)|Part 1 and Part 2: Area under the plasma concentration-time curve from time zero to 24 hours post dose (AUC0-24)|Part 1 and 2: Time to reach maximum observed plasma concentration (tmax)|Part 1 and 2: Half-life associated with terminal slope (λz) of a semi-logarithmic concentrationtime curve (t1/2)|Part 1 and 2: Mean residence time of the drug in the systemic circulation from zero to infinity (MRT)|Part 1 and 2: Terminal elimination rate constant (λz)|Part 1 and 2: Apparent total body clearance of drug from plasms after extravascular administration (acalabrutinib only (CL/F)|Part 1 and 2: Apparent volume of distribution during the terminal phase after extravascular administration (acalabrutinib only) (Vz/F)|Part 1 and 2: Metabolite to parent ratio based on AUCinf and/or AUClast (M:P[AUC])|Part 1 and 2: Metabolite to parent ratio based on Cmax (M:P[Cmax])|Number of subjects with serious and non-serious adverse events
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NCT04380688
|
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. |
Completed |
Phase 2 |
Jun/13/2020 |
Nov/16/2020 |
- Alternative id - D822FC00003
- Interventions - Drug: Acalabrutinib
- Study type - Interventional
- Study results - Has Results
- Locations - Research Site, Anniston, Alabama, United States|Research Site, Mobile, Alabama, United States|Research Site, Escondido, California, United States|Research Site, Fullerton, California, United States|Research Site, Glendale, California, United States|Research Site, Newport Beach, California, United States|Research Site, New Haven, Connecticut, United States|Research Site, Washington, District of Columbia, United States|Research Site, Fort Lauderdale, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Loxahatchee Groves, Florida, United States|Research Site, Fort Wayne, Indiana, United States|Research Site, Louisville, Kentucky, United States|Research Site, Annapolis, Maryland, United States|Research Site, Baltimore, Maryland, United States|Research Site, Bethesda, Maryland, United States|Research Site, Bethesda, Maryland, United States|Research Site, Silver Spring, Maryland, United States|Research Site, Hackensack, New Jersey, United States|Research Site, Albany, New York, United States|Research Site, Bronx, New York, United States|Research Site, Buffalo, New York, United States|Research Site, New York, New York, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Nashville, Tennessee, United States|Research Site, Houston, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Tyler, Texas, United States|Research Site, Richmond, Virginia, United States|Research Site, Renton, Washington, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 62
- Age - 18 Years to 130 Years (Adult, Older Adult)
- Outcome measures - Number of Participants With Adverse Events and Serious Adverse Events|Percentage of Participants Alive and Free of Respiratory Failure at Day 28|Percentage of Participants Alive and Free of Respiratory Failure at Day 14|Percent Change From Baseline in C-reactive Protein.|Percent Change From Baseline in Ferritin|Percent Change From Baseline in Absolute Lymphocyte Count|Overall Survival|Percentage of Participants Alive and Discharged From ICU|Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause|Number of Days Alive and Free of Respiratory Failure|Number of Days With Respiratory Failure|Number of Days Hospitalized|Number of Days in ICU|Number of Days Alive Outside of Hospital|Percent Change From Baseline in Oxygenation Index|Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale|Pharmacokinetics of Acalabrutinib|Pharmacokinetics of ACP-5862
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NCT04665115
|
Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) |
Withdrawn |
Phase 2 |
Dec/01/2021 |
May/01/2025 |
- Alternative id - ACCRU-LY-2001|NCI-2020-11785|P30CA015083
- Interventions - Drug: Ibrutinib|Other: Quality-of-Life Assessment
- Study type - Interventional
- Study results - No Results Available
- Locations - Mayo Clinic in Rochester, Rochester, Minnesota, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients who require hospitalization for their COVID-19 disease or die (Cohort 1)|Proportion of patients who require mechanical ventilation and/or die (Cohort 2)|Rate of "flare phenomena" (Cohort I)|Patient-reported health and symptom status (Cohort I)|Patterns on ibrutinib therapy during COVID-19 infection (Cohort I)|Reasons for hospitalization (Cohort I)|Mortality (Cohort II)|Time to hospital discharge (Cohort II)|Intubation and oxygen supplementation (Cohort II)|Incidence of "flare phenomena" (Cohort II)|Viral clearance|Development of COVID-19 antibodies|Coagulopathy and thrombosis measures|Cytokine measures|Immune subset measures
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NCT04375397
|
Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury |
Completed |
Phase 2 |
Jun/06/2020 |
Jun/08/2021 |
- Alternative id - M20-310
- Interventions - Drug: Ibrutinib|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Stanford Univ School Medicine /ID# 221954, Stanford, California, United States|Medstar Washington Hospital Center /ID# 221886, Washington, District of Columbia, United States|GW Medical Faculty Associates /ID# 222023, Washington, District of Columbia, United States|Midway Immunology and Research /ID# 222004, Fort Pierce, Florida, United States|University of Miami /ID# 223227, Miami, Florida, United States|Triple O Research Institute /ID# 222944, West Palm Beach, Florida, United States|Brigham & Women's Hospital /ID# 221847, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center /ID# 222994, Boston, Massachusetts, United States|Intermountain Healthcare /ID# 221955, Salt Lake City, Utah, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 46
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of Participants Alive and Without Respiratory Failure|Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline|Median Reduction in Days Spent on Supplemental Oxygen|All-Cause Mortality|Percentage of Participants Experiencing Respiratory Failure or Death|Mechanical Ventilation-Free Survival|Days on Mechanical Ventilation|Duration of hospitalization|Time to Discharge|Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio|Oxygenation Index|Number of Participants With Adverse Events|Number of Participants With Abnormal Laboratory Findings
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NCT05024006
|
Public Health Emergency: SOLIDARITY TRIAL Philippines |
Completed |
Not Applicable |
Apr/23/2020 |
Apr/17/2021 |
- Alternative id - SJREB-2020-20
- Interventions - Drug: Remdesivir|Drug: Hydroxychloroquine|Drug: Lopinavir / Ritonavir|Drug: Interferon beta-1a|Drug: Acalabrutinib
- Study type - Interventional
- Study results - No Results Available
- Locations - Baguio General Hospital, Baguio City, Benguet, Philippines|Cebu Doctor's University Hospital, Cebu City, Cebu, Philippines|Perpetual Succor Hospital Cebu, Cebu City, Cebu, Philippines|Vicente Sotto Memorial Medical Center, Cebu City, Cebu, Philippines|Southern Philippines Medical Center, Davao City, Davao, Philippines|West Visayas University Medical Center, Iloilo City, Iloilo, Philippines|Makati Medical Center, Makati City, Metro Manila, Philippines|Chinese General Hospital, Manila, Metro Manila, Philippines|Manila Doctors Hospital, Manila, Metro Manila, Philippines|ManilaMed - Medical Center Philippines, Manila, Metro Manila, Philippines|San Lazaro Hospital, Manila, Metro Manila, Philippines|UP - Philippine General Hospital, Manila, Metro Manila, Philippines|Asian Hospital and Medical Center, Muntinlupa, Metro Manila, Philippines|Research Institute for Tropical Medicine, Muntinlupa, Metro Manila, Philippines|San Juan de Dios Educational Foundation Inc - Hospital, Pasay, Metro Manila, Philippines|The Medical City, Pasig City, Metro Manila, Philippines|Diliman Doctors Hospital, Quezon City, Metro Manila, Philippines|Fe Del Mundo Medical Center, Quezon City, Metro Manila, Philippines|Lung Center of the Philippines, Quezon City, Metro Manila, Philippines|St Luke's Medical Center Quezon City, Quezon City, Metro Manila, Philippines|University of the East Ramon Magsaysay Memorial Medical Center, Quezon City, Metro Manila, Philippines|World Citi Medical Center, Quezon City, Metro Manila, Philippines|Cardinal Santos Medical Center, San Juan, Metro Manila, Philippines|St Luke's Medical Center Global, Taguig, Metro Manila, Philippines|Batangas Medical Center, Batangas, Philippines
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1314
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality|Duration of hospital stay|Time to first receiving ventilation
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NCT04439006
|
Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization |
Active, not recruiting |
Phase 2 |
Oct/23/2020 |
Dec/31/2023 |
- Alternative id - OSU-20135|NCI-2020-03341
- Interventions - Other: Best Practice|Drug: Ibrutinib
- Study type - Interventional
- Study results - No Results Available
- Locations - Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 10
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients with diminished respiratory failure and death|Death|Time from study initiation to 48 hours fever-free|Duration of hospitalization|Time in intensive care unit (ICU)|Time to ICU admission|Number of days requiring supplemental oxygen|Total days of mechanical ventilation|Time to mechanical ventilation|Shock and need for pressure support|Incidence of any infection (viral, fungal, bacterial)|Time to clinical resolution|Incidence of grade 3 or higher adverse events|At the end of therapy (day 14)|Time to viral clearance|Survival
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