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Trial record 1 of 6 for:    Acalabrutinib | Covid19
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Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497948
Recruitment Status : Terminated (

Data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19 did not meet their primary efficacy endpoints.

Based on this higher management made the decision to prematurely terminate the D822FC00005 PK study.

)
First Posted : August 4, 2020
Results First Posted : November 5, 2021
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE June 16, 2020
First Posted Date  ICMJE August 4, 2020
Results First Submitted Date  ICMJE October 29, 2021
Results First Posted Date  ICMJE November 5, 2021
Last Update Posted Date November 17, 2021
Actual Study Start Date  ICMJE September 21, 2020
Actual Primary Completion Date November 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2021)
  • 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) [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1 on Day 1, visit 2 on Day 2 and visit 3 on Day 5 ]
    To summarize the PK parameter AUC12h of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC + PPI
  • 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) [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1 on Day 1, visit 2 on Day 2 and visit 3 on Day5 ]
    To summarize the PK parameter AUClast for Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
  • Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5) [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1(Day 1), visit 2(Day 2) and visit 3(Day 5) ]
    To summarize the PK parameter Cmax of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • Acalabrutinib and ACP-5862 plasma PK parameter: AUC12h [ Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose ]
    To assess the AUC12h (area under plasma concentration-time curve from time zero to 12 hours) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19
  • Acalabrutinib and ACP-5862 plasma PK parameter: AUClast [ Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose ]
    To assess the AUClast (area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19
  • Acalabrutinib and ACP-5862 plasma PK parameter: Cmax [ Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose ]
    To assess the Cmax (maximum observed plasma concentration) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19
  • Type, frequency, severity, and relationship to study intervention of any treatment-emergent AEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study intervention [ Time Frame: From screening to 28 days (+/- 3days) after last dose of acalabrutinib ]
    To Assess Safety and tolerability of acalabrutinib suspension in participants with COVID-19 when administered in the presence of PPIs and BSC
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • Proportion of participants alive and free of respiratory failure at Days 14 and 28 [ Time Frame: 28 Days ]
    To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19
  • Percent change from baseline in CRP at Days 3, 5, 7, 14, 28 [ Time Frame: Baseline and Days 3, 5, 7, 14, 28 ]
    To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19
  • Time to improvement- clinical improvement of ≥ 2 points(from first dose date)on a 9-point category ordinal scale Or live discharge from the hospital Or considered fit for discharge(a score of 0,1,or2 on the ordinal scale)whichever comes first,by Day 28 [ Time Frame: Up to Day 28 ]
    To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Official Title  ICMJE An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19
Brief Summary Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.
Detailed Description This study is to support the ongoing clinical development of acalabrutinib (CALQUENCE®) in hospitalized COVID-19 patients. Because many COVID-19 patients may be unable to swallow capsules due to respiratory failure (eg, they may require endotracheal intubation for ventilator support and Naso Gastric tube placement), it is important to have a clinically acceptable method to administer acalabrutinib (capsules) via NG tube. Furthermore, many hospitalized patients are placed on high doses of proton pump inhibitors (PPIs) (also commonly known as antacid medication). This study is designed to determine the Pharmaco Kinetics (effect of body/ bodily systems on the drug), safety and tolerability of acalabrutinib suspension, when coadministered with a PPI, in participants with confirmed SARS-CoV-2 infection requiring hospitalization due to respiratory failure, attributable to COVID-19 pneumonia and who have an Nasogastric (NG) tube in place.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single group multi dose study. Participants to receive Acalabrutinib + PPI and Best Supportive Care.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Acalabrutinib
Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor
Other Name: CALQUENCE®
Study Arms  ICMJE Single Arm
Single Arm
Intervention: Drug: Acalabrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 29, 2021)
9
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2020)
20
Actual Study Completion Date  ICMJE November 18, 2020
Actual Primary Completion Date November 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant or legally authorized representative must be able to understand the purpose and risks of the study and provide written informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
  2. Participants who are hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by PCR test or other commercial or public health assay in any specimen, as documented by either of the following:

    1. PCR positive in sample collected < 72 hours prior to first dose, OR
    2. PCR positive in sample collected ≥ 72 hours prior to first dose (but no more than 14 days prior to first dose), documented inability to obtain a repeat sample (eg, due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc), AND progressive disease suggestive of ongoing SARS-CoV-2 infection 3 Evidence of respiratory failure attributable to COVID-19 pneumonia (documented radiographically) before enrollment 4 Nasogastric tube or other types of oral or percutaneous gastric feeding tube; placement must be radiographically confirmed and expected to remain in place, as judged by the investigator, for a minimum of 3 days after study enrolment.

      5 Has received treatment with PPIs (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) for a minimum of 24 hours immediately prior to enrollment; any PPI will be permitted, provided it meets the minimum equivalent daily dose of 20 mg rabeprazole.

      Exclusion Criteria:

      1. Any serious and uncorrectable medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the participant's safe participation in and completion of the study.
      2. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
      3. Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
      4. Received BTK inhibitor within 7 days before enrollment.
      5. Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days prior to enrollment. Other anticoagulants are permitted.
      6. Participants on dual antiplatelet and therapeutic anticoagulant therapy (eg, aspirin and therapeutic doses of low molecular weight heparin are not allowed; however, aspirin and prophylactic/ low doses of low-molecular-weight heprin are allowed).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04497948
Other Study ID Numbers  ICMJE D822FC00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party Acerta Pharma BV
Original Responsible Party AstraZeneca
Current Study Sponsor  ICMJE Acerta Pharma BV
Original Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE Not Provided
PRS Account Acerta Pharma BV
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP