Coronavirus Disease 2019 (COVID-19)Phase 2NCT04409509
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
A Phase 2 study testing Garadacimab, Factor XIIa Antagonist Monoclonal Antibody in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring at 14 sites in United States.
Trial summary
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (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?
- Garadacimab, Factor XIIa Antagonist Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jul 2020to 12 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined using a molecular diagnostic test (reverse transcription polymerase chain reaction [RT-PCR] or equivalent) approved by regulatory authorities (including Food and Drug Administration or Brazilian Health Regulatory Agency) or allowed under an emergency use authorization within 14 days before Screening. If a false negative result is suspected, the SARS-CoV-2 test may be repeated within the Screening Period.
- Chest CT scan or X ray results confirming interstitial pneumonia
- Severe COVID 19 disease as evidenced by ≥ 1 of the following criteria at Screening including within 24 hours before Screening:
- Respiratory frequency > 30 breaths per minute
- SpO2 ≤ 93% on room air
Show all 9Show fewer
- Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300
- Ratio of Arterial oxygen saturation to fraction of inspired oxygen (SaO2/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 IP, including expanded access or compassionate use with the only exception being administration of convalescent plasma. Administration of IP is permitted only if an emergency use authorization has been granted (eg, remdesivir). Additionally, off label use of approved drugs (eg, anti IL 6/anti IL 6R) is also permitted.
- Pregnant or breastfeeding (female subjects)
- Intubated and require mechanical ventilation (including ECMO) at the time of randomization
- In the opinion of the investigator, the subject is expected to be intubated in the first 24 hours after IMP administration
- Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
- In the opinion of the investigator, not expected to survive for > 48 hours after admission
Show all 19Show fewer
- Presence of any of the following comorbid conditions prior to randomization and prior to SARS CoV 2 infection:
- Severe heart failure (New York Heart Association Class IV)
- End stage renal disease (Stage ≥ 4) or need for renal replacement therapy
- Biopsy confirmed cirrhosis, portal hypertension, or hepatic encephalopathy
- Malignancy (Stage IV)
- Chronic lung disease requiring the use of oxygen at home
- Active tuberculosis disease
- Active bleeding or a current clinically significant coagulopathy (eg, international normalized ratio [INR] > 1.5) or clinically significant risk for bleeding (eg, recent intracranial hemorrhage or bleeding peptic ulcer within the last 4 weeks)
- History of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin III, protein C or protein S deficiency)
- Known or suspected Grade 3 or 4 infusion-related reaction or hypersensitivity (per Common Terminology Criteria for Adverse Events [CTCAE]) to monoclonal antibody therapy, or hypersensitivity to the IMP or any excipients of the IMP
- Currently receiving a therapy not permitted during the study.
- Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 90 days after receipt of the last dose of IMP
- Any clinical or laboratory abnormality or other underlying conditions (eg, psychological disorders, substance abuse) that would render the subject unsuitable for participation in the study, in the opinion of the investigator
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Inova Alexandria Hospital
Alexandria, Virginia, 22304
PharmaTex Research
Amarillo, Texas, 79109
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Sisters of Charity Hospital/ St. Joseph's Campus
Buffalo, New York, 14225
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304
UT Health Science Center, McGovern Medical School
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
MercyOne North Iowa Medical Center
Mason City, Iowa, 50401
Monument Health Clinical Research
Rapid City, South Dakota, 57701
Theia Clinical Research, LLC
St. Petersburg, Florida, 33707
Holy Name Hospital
Teaneck, New Jersey, 07666
Inspira Health Center Vineland
Vineland, New Jersey, 08360
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702
About this study
Official title: A Phase 2, Multicenter, Double Blind, Randomized, Placebo-Controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID 19)
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- Garadacimab, Factor XIIa Antagonist Monoclonal Antibody, Placebo
- Keywords
- Prevention of respiratory failure
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garadacimab, Factor XIIa Antagonist Monoclonal AntibodyBiological
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
PlaceboDrug
CSL312 diluent administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| CSL312 | Experimental | Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously Receives: Biological: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody |
| Placebo | Placebo comparator | CSL312 diluent administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent of Participants With Tracheal Intubation or Death Prior to Tracheal Intubation
Measured: From randomization to Day 28
Secondary outcomes (24)
Percent of Participants With Death From All Causes
Measured: From randomization to Day 28
Percent of Participants With Tracheal Intubation
Measured: From randomization to Day 28
Number of Participants With ≥ 2-Point Improvement Compared to Baseline on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: From randomization to Day 28
Percent of Participants With ≥ 2-Point Improvement Compared to Baseline on NIAID
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: From randomization to Day 28
Number of Participants Within Each of the Categories of the NIAID at End of Study
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: Day 28
Percent of Participants Within Each of the Categories of the NIAID at End of Study
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: Day 28
Percent of Participants Requiring Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
Measured: From randomization to Day 28
Percent of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO)
None of the enrolled subjects required the use of ECMO during their participation in this study. Therefore, no data to report for this outcome measure.
Measured: From randomization to Day 28
Percent of Participants Requiring High-Flow Nasal Cannula (HFNC)
Measured: From randomization to Day 28
Maximum Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Measured: From randomization to Day 28
Change From Baseline in SOFA Total Score
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Measured: From randomization to Day 28
Change From Baseline in the Individual Components of SOFA Score
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Measured: From randomization to Day 28
Length of Hospital Stay
Measured: From randomization to Day 28 (+/- 2 days)
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to 28 days after CSL312 or placebo administration
Percent of Participants Experiencing AEs
Measured: Up to 28 days after CSL312 or placebo administration
Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Up to 28 days after CSL312 or placebo administration
Percent of Participants Experiencing SAEs
Measured: Up to 28 days after CSL312 or placebo administration
Number of Participants With Adverse Events of Special Interest (AESIs)
Measured: Up to 28 days after CSL312 or placebo administration
Percent of Participants With AESIs
Measured: Up to 28 days after CSL312 or placebo administration
Number of Participants With Anti-CSL312 Antibodies
Measured: Up to 28 days after CSL312 or placebo administration
Maximum Plasma Concentration (Cmax) of CSL312
Measured: Up to 28 days after CSL312 administration
Time to Maximum Plasma Concentration (Tmax) of CSL312
Measured: Up to 28 days after CSL312 administration
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-Last) of CSL312
Measured: Up to 28 days after CSL312 administration
Terminal Half-life (T1/2) of CSL312
Measured: Up to 28 days after CSL312 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jul 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
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 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409509
- Sponsor's protocol ID
- CSL312_COVID-19
- Status last verified
- Jan 2022
- First submitted
- 28 May 2020
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. Lung. 2023 Apr;201(2):159-170. doi: 10.1007/s00408-023-00615-9. Epub 2023 Mar 31.
PubMed 37000214
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. 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 CSL312 in Coronavirus Disease 2019 (COVID 19)
- ClinicalTrials.gov ID
- NCT04409509
- Acronym / sponsor ID
- CSL312_COVID-19
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Prevention of respiratory failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 24 Jan 2022
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 prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)
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 |
|---|---|---|
| CSL312 | Experimental | Biological: Garadacimab, Factor XIIa Antagonist Monoclonal AntibodyGaradacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously |
| Placebo | Placebo comparator | Drug: PlaceboCSL312 diluent 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
- Positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined using a molecular diagnostic test (reverse transcription polymerase chain reaction [RT-PCR] or equivalent) approved by regulatory authorities (including Food and Drug Administration or Brazilian Health Regulatory Agency) or allowed under an emergency use authorization within 14 days before Screening. If a false negative result is suspected, the SARS-CoV-2 test may be repeated within the Screening Period.
- Chest CT scan or X ray results confirming interstitial pneumonia
- Severe COVID 19 disease as evidenced by ≥ 1 of the following criteria at Screening including within 24 hours before Screening:
Key exclusion criteria (19 listed)
- Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an IP, including expanded access or compassionate use with the only exception being administration of convalescent plasma. Administration of IP is permitted only if an emergency use authorization has been granted (eg, remdesivir). Additionally, off label use of approved drugs (eg, anti IL 6/anti IL 6R) is also permitted.
- Pregnant or breastfeeding (female subjects)
- Intubated and require mechanical ventilation (including ECMO) at the time of randomization
- In the opinion of the investigator, the subject is expected to be intubated in the first 24 hours after IMP administration
- Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
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 |
|---|---|---|
| Garadacimab, Factor XIIa Antagonist Monoclonal AntibodyGaradacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously | Biological | CSL312 |
| PlaceboCSL312 diluent administered intravenously | Drug | Placebo |
Primary outcome
The Percent of Participants With Tracheal Intubation or Death Prior to Tracheal Intubation
Time frame: From randomization to Day 28
24 secondary outcomes
Percent of Participants With Death From All Causes
Time frame: From randomization to Day 28
Percent of Participants With Tracheal Intubation
Time frame: From randomization to Day 28
Number of Participants With ≥ 2-Point Improvement Compared to Baseline on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
Time frame: From randomization to Day 28
Percent of Participants With ≥ 2-Point Improvement Compared to Baseline on NIAID
Time frame: From randomization to Day 28
Number of Participants Within Each of the Categories of the NIAID at End of Study
Time frame: Day 28
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Time frame: Day 28
Percent of Participants Requiring Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
Time frame: From randomization to Day 28
Percent of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO)
Time frame: From randomization to Day 28
Percent of Participants Requiring High-Flow Nasal Cannula (HFNC)
Time frame: From randomization to Day 28
Maximum Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score
Time frame: From randomization to Day 28
Change From Baseline in SOFA Total Score
Time frame: From randomization to Day 28
Change From Baseline in the Individual Components of SOFA Score
Time frame: From randomization to Day 28
Length of Hospital Stay
Time frame: From randomization to Day 28 (+/- 2 days)
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 28 days after CSL312 or placebo administration
Percent of Participants Experiencing AEs
Time frame: Up to 28 days after CSL312 or placebo administration
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 28 days after CSL312 or placebo administration
Percent of Participants Experiencing SAEs
Time frame: Up to 28 days after CSL312 or placebo administration
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to 28 days after CSL312 or placebo administration
Percent of Participants With AESIs
Time frame: Up to 28 days after CSL312 or placebo administration
Number of Participants With Anti-CSL312 Antibodies
Time frame: Up to 28 days after CSL312 or placebo administration
Maximum Plasma Concentration (Cmax) of CSL312
Time frame: Up to 28 days after CSL312 administration
Time to Maximum Plasma Concentration (Tmax) of CSL312
Time frame: Up to 28 days after CSL312 administration
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-Last) of CSL312
Time frame: Up to 28 days after CSL312 administration
Terminal Half-life (T1/2) of CSL312
Time frame: Up to 28 days after CSL312 administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37000214Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. Lung. 2023 Apr;201(2):159-170. doi: 10.1007/s00408-023-00615-9. Epub 2023 Mar 31.
- 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.
Related trials for Coronavirus Disease 2019 (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Study Director study director
CSL Behring
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Garadacimab, Factor XIIa Antagonist Monoclonal Antibody in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring at 14 sites in United States.
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 19 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2022). 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?
The Percent of Participants With Tracheal Intubation or Death Prior to Tracheal Intubation (time frame: From randomization to Day 28). 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 NCT04409509, 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 24 Jan 2022.