Coronavirus Disease 2019 (COVID-19)Phase 2NCT04519424
CSL324 in COVID-19
A Phase 2 study testing CSL324 in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring.
Trial summary
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- CSL324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time informed consent is obtained
- Positive for SARS-CoV-2 infection determined by a diagnostic test approved by the Food and Drug Administration (FDA) or allowed under an emergency use authorization
- Chest computed tomography (CT) scan or X ray results confirming interstitial pneumonia
- Meets ≥ 1 of the following criteria (subjects improving while on respiratory support still qualify):
- Respiratory rate > 30 breaths per minute
- Peripheral (capillary) oxygen saturation (SpO2) ≤ 93% on room air
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- Partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) ratio (PaO2 / FiO2) < 300
- SpO2 / FiO2 ratio < 218 (if PaO2 / FiO2 ratio is not available)
- Radiographic lung infiltrates > 50%
Who cannot join
- Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an investigational product (ie, not yet marketed), including expanded access or compassionate use
- Exceptions:
- Administration of investigational product with emergency use authorization granted for treatment of COVID 19 (eg, remdesivir) is permitted
- Convalescent plasma as part of approved special access programs such as expanded access, emergency IND, or compassionate use is permitted
- Pregnant or breastfeeding (female subjects)
- Intubated and requires mechanical ventilation (including ECMO) at time of randomization
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- Exception: use of HFNC oxygen and noninvasive ventilation are permitted
- Endotracheal intubation is imminent, in the opinion of the investigator
- Not expected to survive for more than 48 hours after hospital admission, in the opinion of the investigator
- Presence of any of the following comorbid conditions before randomization and prior to SARS-CoV-2 infection:
- New York Heart Association class IV heart failure
- Stage 4 or 5 chronic kidney disease or requires renal replacement therapy
- Biopsy proven cirrhosis, portal hypertension or hepatic encephalopathy
- Stage IV malignancy
- Chronic lung disease requiring home oxygen
- Active tuberculosis
- History or evidence of pulmonary alveolar proteinosis
- Confirmed diagnosis or clinical suspicion of bacterial pneumonia or active uncontrolled bacterial, fungal, or non SARS-CoV-2 viral infection at Screening
- Absolute neutrophil count (ANC) value < 5 × 109 cells/L at Screening (can be lowered up to < 1.5 × 109 cells/L after Independent Data Monitoring Committee review of safety data, if CSL324 induced neutropenia is not assessed as a safety concern)
- Currently receiving a prohibited therapy including G-CSF, granulocyte-macrophage colony-stimulating factor (GM-CSF), or antibody against interleukin 6 (IL-6) / IL 6 receptor (anti IL-6 / 6R)
About this study
Official title: A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19.
For the purposes of this study, standard of care (SOC) may include any written or established treatment protocol followed at the study site for the treatment of severe COVID-19 or its complications, including off-label use of marketed pharmaceutical products and / or products with emergency use authorization granted for the treatment of COVID-19 (ie, not yet marketed) (eg, remdesivir).
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- CSL324, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL324Biological
Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
PlaceboDrug
Normal saline (0.9% sodium chloride)
| Study group | Role | What they receive |
|---|---|---|
| CSL324 | Experimental | CSL324 administered intravenously Receives: Biological: CSL324 |
| Placebo | Placebo comparator | Normal saline administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation
Measured: Randomization to Day 28
Secondary outcomes (18)
Proportion of deaths from all causes
Measured: Randomization to Day 28
Proportion of subjects intubated
Measured: Randomization to Day 28
Median length of stay in hospital
Measured: Randomization to Day 28
Number and proportion of subjects with at least a 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale
Measured: Randomization to Day 28
Number and proportion of subjects within each of the categories of the NIAID ordinal scale
Measured: Daily up to Day 28
Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)
Measured: Randomization to Day 28
Proportion of subjects using high-flow nasal cannula (HFNC)
Measured: Randomization to Day 28
Proportion of subjects using extracorporeal membrane oxygenation (ECMO)
Measured: Randomization to Day 28
Maximum Change in Sequential Organ Failure Assessment (SOFA) score
Measured: Randomization to Day 28
Change in SOFA score and in individual components of the SOFA score
Measured: Baseline to Day 28
Number and proportion of subjects experiencing adverse events (AEs)
Measured: Up to 60 days
Number and proportion of subjects experiencing serious adverse events (SAEs)
Measured: Up to 60 days
Number and proportion of subjects experiencing adverse events of special interest (AESIs)
Measured: Up to 60 days
Presence of anti-CSL324 antibodies
Measured: Up to 28 days
Maximum concentration (Cmax) of CSL324
Measured: Up to 28 days
Time to reach maximum concentration (Tmax) of CSL324
Measured: Up to 28 days
Area under the concentration-time curve (AUC0-last) of CSL324
Measured: Up to 28 days
Trough concentration (Ctrough) of CSL324
Measured: Before dose on Day 4 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Due to business reasons, not safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519424
- Sponsor's protocol ID
- CSL324_COVID-19
- Status last verified
- Oct 2020
- First submitted
- 18 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04519424
- Acronym / sponsor ID
- CSL324_COVID-19
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to business reasons, not safety issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19.
For the purposes of this study, standard of care (SOC) may include any written or established treatment protocol followed at the study site for the treatment of severe COVID-19 or its complications, including off-label use of marketed pharmaceutical products and / or products with emergency use authorization granted for the treatment of COVID-19 (ie, not yet marketed) (eg, remdesivir).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL324 | Experimental | Biological: CSL324CSL324 administered intravenously |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years at the time informed consent is obtained
- Positive for SARS-CoV-2 infection determined by a diagnostic test approved by the Food and Drug Administration (FDA) or allowed under an emergency use authorization
- Chest computed tomography (CT) scan or X ray results confirming interstitial pneumonia
- Meets ≥ 1 of the following criteria (subjects improving while on respiratory support still qualify):
Key exclusion criteria (20 listed)
- Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an investigational product (ie, not yet marketed), including expanded access or compassionate use
- Pregnant or breastfeeding (female subjects)
- Intubated and requires mechanical ventilation (including ECMO) at time of randomization
- Endotracheal intubation is imminent, in the opinion of the investigator
- Not expected to survive for more than 48 hours after hospital admission, in the opinion of the investigator
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 |
|---|---|---|
| CSL324Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody | Biological | CSL324 |
| PlaceboNormal saline (0.9% sodium chloride) | Drug | Placebo |
Primary outcome
Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation
Time frame: Randomization to Day 28
18 secondary outcomes
Proportion of deaths from all causes
Time frame: Randomization to Day 28
Proportion of subjects intubated
Time frame: Randomization to Day 28
Median length of stay in hospital
Time frame: Randomization to Day 28
Number and proportion of subjects with at least a 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale
Time frame: Randomization to Day 28
Number and proportion of subjects within each of the categories of the NIAID ordinal scale
Time frame: Daily up to Day 28
Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)
Time frame: Randomization to Day 28
Proportion of subjects using high-flow nasal cannula (HFNC)
Time frame: Randomization to Day 28
Proportion of subjects using extracorporeal membrane oxygenation (ECMO)
Time frame: Randomization to Day 28
Maximum Change in Sequential Organ Failure Assessment (SOFA) score
Time frame: Randomization to Day 28
Change in SOFA score and in individual components of the SOFA score
Time frame: Baseline to Day 28
Number and proportion of subjects experiencing adverse events (AEs)
Time frame: Up to 60 days
Number and proportion of subjects experiencing serious adverse events (SAEs)
Time frame: Up to 60 days
Number and proportion of subjects experiencing adverse events of special interest (AESIs)
Time frame: Up to 60 days
Presence of anti-CSL324 antibodies
Time frame: Up to 28 days
Maximum concentration (Cmax) of CSL324
Time frame: Up to 28 days
Time to reach maximum concentration (Tmax) of CSL324
Time frame: Up to 28 days
Area under the concentration-time curve (AUC0-last) of CSL324
Time frame: Up to 28 days
Trough concentration (Ctrough) of CSL324
Time frame: Before dose on Day 4 and Day 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Yes. CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSL324 in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring.
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 9 inclusion and 20 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: withdrawn, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation (time frame: Randomization to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.