Back to resultsAcalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Acalabrutinib
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring 2019 novel coronavirus disease, Acalabrutinib, Btk inhibitor
Eligibility Criteria
Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
- Men and women ≥18 years of age at the time of signing the informed consent form
- Confirmed infection with SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
- COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
- Able to swallow pills
- Willing to follow contraception guidelines
Exclusion Criteria:
- Respiratory failure at time of screening due to COVID-19
- Known medical resuscitation within 14 days of randomization
- Pregnant or breast feeding
- Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment detected within 24 hours at screening (per local lab)
- Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
- Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
- Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study
- Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm 1
Arm 2
Arm Description
Acalabrutinib+ Best Supportive Care
Best Supportive Care
Outcomes
Primary Outcome Measures
Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Secondary Outcome Measures
Number of Participants With Adverse Events and Serious Adverse Events
Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Percent Change From Baseline in C-reactive Protein.
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Percent Change From Baseline in Ferritin
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Percent Change From Baseline in Absolute Lymphocyte Count
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Overall Survival
Median overall survival, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
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
Median time to first occurrence of respiratory failure or death, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
Number of Days Alive and Free of Respiratory Failure
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Number of Days With Respiratory Failure
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation For participants who die (due to any cause) prior to Day 28, days from death to Day 28 are counted as days with respiratory failure. For participants in hospital and experiencing respiratory failure at the time they withdraw from the study, days from last known status to Day 28 are counted as days with respiratory failure.
Number of Days Hospitalized
For this summary, the hospitalization must be considered clinically indicated to count as a day hospitalized.
For participants who die (due to any cause) prior to Day 28, days from death to Day 28 are counted as days hospitalized.
For participants in hospital at the time they withdraw from the study, days from last known status to Day 28 are counted as days hospitalized.
Number of Days in ICU
For this summary, the ICU stay must be considered clinically indicated to count as a day in ICU.
For participants who die (due to any cause) prior to Day 90, days from death to Day 90 are counted as days in ICU.
Number of Days Alive Outside of Hospital
Number of Days Alive Outside of Hospital
Percent Change From Baseline in Oxygenation Index
Baseline is defined as the result obtained on the date of randomization.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale
9-point category ordinal scale: 0. * Uninfected, no clinical or virological evidence of infection
Ambulatory, no limitation of activities
Ambulatory, limitation of activities
Hospitalized - mild disease, no oxygen therapy
Hospitalized - mild disease, oxygen by mask or nasal prongs
Hospitalized - severe disease, non-invasive ventilation or high flow oxygen
Hospitalised - severe disease, intubation and mechanical ventilation
Hospitalized - severe disease, ventilation and additional organ support, such as pressors, renal replacement therapy, extracorporeal membrane oxygenation
Death
Median time to first occurrence of respiratory failure or death, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
Pharmacokinetics of Acalabrutinib
Summary of plasma concentrations (ng/mL) of acalabrutinib
Pharmacokinetics of ACP-5862
Summary of plasma concentrations (ng/mL) of ACP-5862
Full Information
NCT ID
NCT04346199
First Posted
April 9, 2020
Last Updated
September 15, 2021
Sponsor
AstraZeneca
Collaborators
Acerta Pharma BV
1. Study Identification
Unique Protocol Identification Number
NCT04346199
Brief Title
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Acronym
CALAVI
Official Title
A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Acerta Pharma BV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
2019 novel coronavirus disease, Acalabrutinib, Btk inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Acalabrutinib+ Best Supportive Care
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
Best Supportive Care
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Intervention Description
Acalabrutinib- administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Description
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Time Frame
At Day 14
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events and Serious Adverse Events
Time Frame
Screening to 28 (+3) days after last dose of acalabrutinib (for acalabrutinib + BSC participants) or to 38 (+3) days after randomization (for BSC alone participants)
Title
Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Description
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Time Frame
At Day 28
Title
Percent Change From Baseline in C-reactive Protein.
Description
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Time Frame
Days 3, 5, 7, 10, 14, 28
Title
Percent Change From Baseline in Ferritin
Description
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Time Frame
Days 3, 5, 7, 10, 14, 28
Title
Percent Change From Baseline in Absolute Lymphocyte Count
Description
Baseline is defined as the result obtained on the date of randomization. If no result was obtained on the date of randomization, the last result prior to the date of randomization is used.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Time Frame
Days 3, 5, 7, 10, 14, 28
Title
Overall Survival
Description
Median overall survival, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
Time Frame
From randomization until 90 days after randomization. Safety Issue:
Title
Percentage of Participants Alive and Discharged From ICU
Time Frame
At Day 14 and at Day 28
Title
Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause
Description
Median time to first occurrence of respiratory failure or death, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
Time Frame
From randomization to 28 days after randomization.
Title
Number of Days Alive and Free of Respiratory Failure
Description
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Time Frame
From randomization to 28 days after randomization.
Title
Number of Days With Respiratory Failure
Description
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation For participants who die (due to any cause) prior to Day 28, days from death to Day 28 are counted as days with respiratory failure. For participants in hospital and experiencing respiratory failure at the time they withdraw from the study, days from last known status to Day 28 are counted as days with respiratory failure.
Time Frame
From randomization to 28 days after randomization.
Title
Number of Days Hospitalized
Description
For this summary, the hospitalization must be considered clinically indicated to count as a day hospitalized.
For participants who die (due to any cause) prior to Day 28, days from death to Day 28 are counted as days hospitalized.
For participants in hospital at the time they withdraw from the study, days from last known status to Day 28 are counted as days hospitalized.
Time Frame
From randomization to 28 days after randomization.
Title
Number of Days in ICU
Description
For this summary, the ICU stay must be considered clinically indicated to count as a day in ICU.
For participants who die (due to any cause) prior to Day 90, days from death to Day 90 are counted as days in ICU.
Time Frame
From randomization to 90 days after randomization.
Title
Number of Days Alive Outside of Hospital
Time Frame
From randomization to 28 days after randomization.
Title
Number of Days Alive Outside of Hospital
Time Frame
From randomization to 90 days after randomization.
Title
Percent Change From Baseline in Oxygenation Index
Description
Baseline is defined as the result obtained on the date of randomization.
Percent change from baseline at Day X is calculated by multiplying the following result by 100%: (Day X value - Baseline value)/Baseline value.
The mean of this result for all analyzed patients is taken to get the mean percent change from baseline.
Time Frame
Days 3, 5, 7, 10, 14, 28
Title
Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale
Description
9-point category ordinal scale: 0. * Uninfected, no clinical or virological evidence of infection
Ambulatory, no limitation of activities
Ambulatory, limitation of activities
Hospitalized - mild disease, no oxygen therapy
Hospitalized - mild disease, oxygen by mask or nasal prongs
Hospitalized - severe disease, non-invasive ventilation or high flow oxygen
Hospitalised - severe disease, intubation and mechanical ventilation
Hospitalized - severe disease, ventilation and additional organ support, such as pressors, renal replacement therapy, extracorporeal membrane oxygenation
Death
Median time to first occurrence of respiratory failure or death, calculated using the Kaplan-Meier technique. Confidence interval for median overall survival (days) is derived based on Brookmeyer-Crowley method with log-log transformation.
Time Frame
From randomization to 28 days after randomization.
Title
Pharmacokinetics of Acalabrutinib
Description
Summary of plasma concentrations (ng/mL) of acalabrutinib
Time Frame
Day 3 and Day 7
Title
Pharmacokinetics of ACP-5862
Description
Summary of plasma concentrations (ng/mL) of ACP-5862
Time Frame
Day 3 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
Men and women ≥18 years of age at the time of signing the informed consent form
Confirmed infection with SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
Able to swallow pills
Willing to follow contraception guidelines
Exclusion Criteria:
Respiratory failure at time of screening due to COVID-19
Known medical resuscitation within 14 days of randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment detected within 24 hours at screening (per local lab)
Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study
Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Facility Information:
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Research Site
City
Monte Grande
ZIP/Postal Code
B1842
Country
Argentina
Facility Name
Research Site
City
Ramos Mejía
ZIP/Postal Code
B1704
Country
Argentina
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-687
Country
Brazil
Facility Name
Research Site
City
Brasillia
ZIP/Postal Code
72145-450
Country
Brazil
Facility Name
Research Site
City
Florianópolis
ZIP/Postal Code
88036-800
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Ribeirão Preto
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Research Site
City
Sao Bernardo do Campo
ZIP/Postal Code
09715090
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04004-030
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Research Site
City
Curico
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500692
Country
Chile
Facility Name
Research Site
City
Talca
ZIP/Postal Code
3460001
Country
Chile
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560002
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Research Site
City
D.F
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64461
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
03103
Country
Mexico
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15324
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
Research Site
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Research Site
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Research Site
City
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Umraniye
ZIP/Postal Code
34760
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
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Description
Redacted CSP
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D822FC00001&attachmentIdentifier=908e6751-0835-4843-b04e-6d6dcd7f450b&fileName=D822FC00001_CALAVI_CSR_Synopsis.pdf&versionIdentifier=
Description
Redacted CSR Synopsis
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D822FC00001&attachmentIdentifier=29a4f0dc-6f45-4d79-ad24-27aae0e3666c&fileName=D822FC00001_CALAVI_SAP.pdf&versionIdentifier=
Description
Redacted SAP
Learn more about this trial
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
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