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History of Changes for Study: NCT04346199
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. CALAVI (Calquence Against the Virus) (ACE-ID-201)
Latest version (submitted September 15, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 14, 2020 None (earliest Version on record)
2 April 15, 2020 Study Status and Contacts/Locations
3 May 7, 2020 Contacts/Locations, Outcome Measures, Study Status, Oversight, Study Identification, IPDSharing, Study Design, Eligibility, Arms and Interventions, Conditions and Study Description
4 July 24, 2020 Recruitment Status, Contacts/Locations, Study Status and Oversight
5 October 14, 2020 Recruitment Status, Contacts/Locations, Study Status and Study Design
6 February 1, 2021 Recruitment Status, Study Status, Contacts/Locations, IPDSharing and Study Design
7 September 8, 2021 Contacts/Locations, Outcome Measures, Study Status, Document Section, Results and References
8 September 15, 2021 Participant Flow and Study Status
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Study NCT04346199
Submitted Date:  April 14, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: D822FC00001
Brief Title: Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. CALAVI (Calquence Against the Virus) (ACE-ID-201)
Official Title: A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: December 18, 2020
Primary Completion: January 28, 2022 [Anticipated]
Study Completion: January 28, 2022 [Anticipated]
First Submitted: April 9, 2020
First Submitted that
Met QC Criteria:
April 14, 2020
First Posted: April 15, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 14, 2020
Last Update Posted: April 15, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators: Acerta Pharma BV
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: ACE-ID- 201 will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Detailed Description:
Open or close this module Conditions
Conditions: COVID-19
Keywords: 2019 novel coronavirus disease
Acalabrutinib
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Study will consist of two parts Part1: two treatments acalabrutinib +best supportive care or best supportive care alone Part2: intensive care unit patients treated with acalabrutinib with best supportive care.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 428 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1
Acalabrutinib+ Best Supportive Care
Drug: Acalabrutinib
Acalabrutinib- administered orally or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
No Intervention: Arm 2
Best Supportive Care
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Treatment failure rate
[ Time Frame: Approximately 30 days ]

Treatment failure rate, where treatment failure is defined as use of assisted ventilation or death.
Secondary Outcome Measures:
1. Number of days alive free of assisted ventilation
[ Time Frame: Approximately 30 days ]

2. Number of days with assisted ventilator use
[ Time Frame: Approximately 30 days ]

3. Number of days hospitalized
[ Time Frame: Approximately 30 days ]

4. Number of days in ICU
[ Time Frame: Approximately 30 days ]

5. Number of days alive outside of hospital
[ Time Frame: Approximately 30 days ]

6. Number of days alive outside of hospital
[ Time Frame: Approximately 90 days ]

7. Occurrence of Adverse Events and Serious Adverse Events
[ Time Frame: Approximately 30 days ]

8. Pharmacokinetics of acalabrutinib and its active metabolite ACP-5862 (Cmax)
[ Time Frame: Approximately 30 days ]

Peak Plasma Concentration (Cmax)
9. Pharmacokinetics of acalabrutinib and its active metabolite ACP-5862 (Tmax)
[ Time Frame: Approximately 30 days ]

Time to Maximum Concentration (Tmax)
10. Pharmacokinetics of acalabrutinib and its active metabolite ACP-5862 (AUC)
[ Time Frame: Approximately 30 days ]

Area under the plasma concentration versus time curve (AUC)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 130 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

For Part 1 (Arm 1 and Arm 2):

  1. 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)
  2. Men and women ≥18 years of age at the time of signing the informed consent form
  3. Confirmed COVID-19 infection confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of study entry) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires 2-5

L/min of oxygen with at least one of the follow laboratory values:

  1. Ferritin > 300 ng/mL for men and > 150 ng/mL for women
  2. C-reactive protein (CRP) ≥ 10 mg/L
  3. D-dimer > 1 mg/L
  4. Absolute lymphocyte count < 1000 cells/μL 4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube 5. Willing to follow contraception guidelines

For Part 2 Intensive Care Unit (ICU Cohort):

  1. 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)
  2. Men and women ≥18 years of age at the time of signing the informed consent form
  3. Confirmed COVID-19 infection requiring ICU admission and requiring

    ≥ 6 L/min of oxygen or PaO2/FiO2 ≤300 mm Hg)

  4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
  5. Willing to follow contraception guidelines

Exclusion Criteria:

For Part 1 and Part 2 (All Subjects):

  1. Pregnant or breast feeding
  2. Are not committed to aggressive management. For example, the subject's family or primary physician are unwilling to place the subject on mechanical ventilation or an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation, is present.
  3. Suspected, uncontrolled active bacterial, fungal, viral, or other infection (besides COVID 19)
  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
  5. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, congestive heart failure
  6. Use of active systemic or inhaled corticosteroids
  7. Concomitant use of JAK, PI3K, or Btk (other than acalabrutinib) inhibitors with acalabrutinib.

For Part 1 (only):

  1. In ICU or on invasive mechanical ventilation or ECMO machine before randomization.
  2. Known medical resuscitation within 14 days of randomization
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Central Contact Backup: AstraZeneca Cancer Study Locator
Telephone: 18774004656
Email: astrazeneca@emergingmed.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
Informed Consent Form (ICF)
Time Frame:
Study start to completion date
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
Open or close this module References
Citations:
Links:
Available IPD/Information:

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