COVID-19Phase 2CALAVINCT04346199
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
A Phase 2 study testing Acalabrutinib in people with COVID-19, run by AstraZeneca at 50 sites in 14 countries.
Trial summary
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 50 sitesin 14 countries
- Study dates
- 12 Jun 2020to 17 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
50 sites in 14 countries.
50 sites in 14 countries
Brazil11 sites
Research Site
Botucatu, 18618-687
Research Site
Brasillia, 72145-450
Research Site
Florianópolis, 88036-800
Research Site
Porto Alegre, 90035-903
Research Site
Porto Alegre, 91350-200
Research Site
Ribeirão Preto, 14051-140
Research Site
Salvador, 40110-060
Research Site
São Bernardo do Campo, 09715090
Research Site
São Paulo, 01308-050
Research Site
São Paulo, 01327-001
Research Site
São Paulo, 04004-030
Russia5 sites
Research Site
Moscow, 111539
Research Site
Moscow, 119992
Research Site
Moscow, 123182
Research Site
Moscow, 143442
Research Site
Murmansk, 183047
South Africa5 sites
Research Site
Cape Town, 7500
Research Site
George, 6529
Research Site
Johannesburg, 1827
Research Site
Johannesburg, 2193
Research Site
Pretoria, 0157
Turkey (Türkiye)5 sites
Research Site
Ankara, 06800
Research Site
Bakırköy, 34147
Research Site
Istanbul, 34214
Research Site
Istanbul
Research Site
Ümraniye, 34760
Argentina4 sites
Research Site
Ciudad de Buenos Aires, 1221
Research Site
Ciudad de Buenos Aires, C1180AAX
Research Site
Monte Grande, B1842
Research Site
Ramos Mejía, B1704
Chile3 sites
Research Site
Curicó, 3341643
Research Site
Santiago, 7500692
Research Site
Talca, 3460001
Germany3 sites
Research Site
Cologne, 50937
Research Site
Frankfurt, 60590
Research Site
Gauting, 82131
Mexico3 sites
Research Site
D.F, 14050
Research Site
México, 03103
Research Site
Monterrey, 64461
Peru3 sites
Research Site
Lima, 15324
Research Site
Lima, LIMA 11
Research Site
Lima, LIMA 1
About this study
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
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
- Conditions
- COVID-19
- Being tested
- Acalabrutinib
- Keywords
- 2019 novel coronavirus disease, Acalabrutinib, Btk inhibitor
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Acalabrutinib- administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Acalabrutinib+ Best Supportive Care Receives: Drug: Acalabrutinib |
| Arm 2 | No intervention | Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Day 14
Secondary outcomes (18)
Number of Participants With Adverse Events and Serious Adverse Events
Measured: 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)
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
Measured: At Day 28
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.
Measured: Days 3, 5, 7, 10, 14, 28
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.
Measured: Days 3, 5, 7, 10, 14, 28
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.
Measured: Days 3, 5, 7, 10, 14, 28
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.
Measured: From randomization until 90 days after randomization. Safety Issue:
Percentage of Participants Alive and Discharged From ICU
Measured: At Day 14 and at Day 28
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.
Measured: From randomization to 28 days after randomization.
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
Measured: From randomization to 28 days after randomization.
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.
Measured: From randomization to 28 days after randomization.
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.
Measured: From randomization to 28 days after randomization.
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.
Measured: From randomization to 90 days after randomization.
Number of Days Alive Outside of Hospital
Measured: From randomization to 28 days after randomization.
Number of Days Alive Outside of Hospital
Measured: From randomization to 90 days after randomization.
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.
Measured: Days 3, 5, 7, 10, 14, 28
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.
Measured: From randomization to 28 days after randomization.
Pharmacokinetics of Acalabrutinib
Summary of plasma concentrations (ng/mL) of acalabrutinib
Measured: Day 3 and Day 7
Pharmacokinetics of ACP-5862
Summary of plasma concentrations (ng/mL) of ACP-5862
Measured: Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start12 Jun 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acerta Pharma BV
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346199
- Sponsor's protocol ID
- D822FC00001
- Acronym
- CALAVI
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2020
- Last updated
- 17 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Scheinberg P, Khoshnevis MR, Robinson PA, Guerreros A, Sato VAH, Fonseca BAL, Prozesky HW, Romero JOC, Fogliatto L, Meisenberg BR, Park DJ, Gupta A, Patel P, Townsley DM, Zheng L, Munugalavadla V. Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization. Immunohorizons. 2025 May 30;9(7):vlaf023. doi: 10.1093/immhor/vlaf023.
PubMed 40461100
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04346199
- Acronym / sponsor ID
- CALAVI / D822FC00001
- Conditions
- COVID-19
- Keywords
- 2019 novel coronavirus disease, Acalabrutinib, Btk inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Acerta Pharma BV
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AcalabrutinibAcalabrutinib+ Best Supportive Care |
| Arm 2 | No intervention | –Best Supportive Care |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAcalabrutinib- administered orally | Drug | Arm 1 |
Primary outcome
Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Time frame: 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
18 secondary outcomes
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)
Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Time frame: At Day 28
Percent Change From Baseline in C-reactive Protein.
Time frame: Days 3, 5, 7, 10, 14, 28
Percent Change From Baseline in Ferritin
Time frame: Days 3, 5, 7, 10, 14, 28
Percent Change From Baseline in Absolute Lymphocyte Count
Time frame: Days 3, 5, 7, 10, 14, 28
Overall Survival
Time frame: From randomization until 90 days after randomization. Safety Issue:
Percentage of Participants Alive and Discharged From ICU
Time frame: At Day 14 and at Day 28
Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause
Time frame: From randomization to 28 days after randomization.
Number of Days Alive and Free of Respiratory Failure
Time frame: From randomization to 28 days after randomization.
Number of Days With Respiratory Failure
Time frame: From randomization to 28 days after randomization.
Number of Days Hospitalized
Time frame: From randomization to 28 days after randomization.
Number of Days in ICU
Time frame: From randomization to 90 days after randomization.
Number of Days Alive Outside of Hospital
Time frame: From randomization to 28 days after randomization.
Number of Days Alive Outside of Hospital
Time frame: From randomization to 90 days after randomization.
Percent Change From Baseline in Oxygenation Index
Time frame: Days 3, 5, 7, 10, 14, 28
Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale
Time frame: From randomization to 28 days after randomization.
Pharmacokinetics of Acalabrutinib
Time frame: Day 3 and Day 7
Pharmacokinetics of ACP-5862
Time frame: Day 3 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40461100Scheinberg P, Khoshnevis MR, Robinson PA, Guerreros A, Sato VAH, Fonseca BAL, Prozesky HW, Romero JOC, Fogliatto L, Meisenberg BR, Park DJ, Gupta A, Patel P, Townsley DM, Zheng L, Munugalavadla V. Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization. Immunohorizons. 2025 May 30;9(7):vlaf023. doi: 10.1093/immhor/vlaf023.
- Redacted CSPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acalabrutinib in people with COVID-19, run by AstraZeneca at 50 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Brazil, Russia, South Africa, Turkey (Türkiye), Argentina and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Alive and Free of Respiratory Failure at Day 14 (time frame: At Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.