COVID-19Phase 2ABACCuSNCT04432272
ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
A Phase 2 study testing COVID-19 convalescent plasma in people with COVID-19 and Severe Acute Respiratory Syndrome (SARS), run by Corewell Health East at 1 site in United States.
Trial summary
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Severe Acute Respiratory Syndrome (SARS), Coronavirus Infections
- What is being tested?
- COVID-19 convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 28 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years of age or older.
- Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2 Reverse-transcription polymerase chain reaction (RT-PCR) testing.
- Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of breath) at time of screening.
- Patient requires >6 L nasal cannula oxygen (Group A) or intubated (Group B).
- Patient (or their legal authorized representative) is willing and able to provide written informed consent and comply with all protocol requirements.
Who cannot join
- For patients in Group A admitted for >14 days
- Female subjects with positive pregnancy test, breastfeeding, or planning to become --pregnant or breastfeed during the study period.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Patients currently undergoing cancer treatment or those who are presently immunocompromised.
- Patient who in the opinion of the investigator will not be a good study candidate.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma.
A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study.
Read more
Participants will be assigned to a study group depending on how sick they are.
- Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator
- Group B: Those who require a ventilator to preserve their life.
Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
Read the detailed description
This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria). Participants in both group A and group B will receive COVID-19 convalescent plasma. Group A will include hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain O2 saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. Group B will include hospitalized COVID-19 patients ages ≥18 years requiring intubation. Patients may be enrolled in group A within 14 days of admission to the hospital and may be enrolled in group B at any time after intubation. A total of 300 eligible subjects with significant oxygen requirements and 200 eligible subjects who require intubation will be included in the study. They will receive convalescent plasma from either a patient who has recovered from COVID-19 or from an asymptomatic carrier with confirmed Immunoglobulin-G (IgG) antibodies against SARS-CoV-2. Subjects will not be randomized. The amount of anti-SARS-CoV-2 IgG and Immunoglobulin-A (IgA) antibodies in any unit of plasma will not be known when the unit is assigned to the patient. This will allow us to examine the relationship between the amount of anti-SARS-CoV-2 antibody and outcomes. Analysis will be based on measurement of optical density of the IgG level in the unit of plasma the patient is randomly supplied by the blood bank. While investigators and patients will be aware the patient is receiving a unit of COVID-19 convalescent plasma, both the investigators and the patients will be blinded to the antibody content of that unit.
COVID-19 convalescent plasma (1 unit; ~200mL) will be produced by a blood bank licensed to produce plasma using standard screening and safety procedures. The product may be procured from patients who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA.
Participants at the eight Michigan hospitals comprising the Beaumont Health system may be eligible to participate. Study oversight and coordination will occur centrally, from the Infectious Disease Research Department at Beaumont's Royal Oak campus.
- Being tested
- COVID-19 convalescent plasma
- Keywords
- therapeutic treatment, COVID-19 convalescent plasma, anti-SARS-CoV-2 antibody, IgA, IgG, COVID-19 pandemic
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 convalescent plasmaBiological
Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. Receives: Biological: COVID-19 convalescent plasma |
| Group B | Experimental | Hospitalized COVID-19 patients ages ≥18 years requiring intubation. Receives: Biological: COVID-19 convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance of Intubation at 28 Days (Group A)
Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated
Measured: 28 days
Mortality (Group B)
Count of group B participants (participants who are intubated at study entry) who die
Measured: 28 days
Secondary outcomes (17)
Cardio-circulatory Arrest
Count of participants who experienced cardio-circulatory arrest
Measured: 28 days
Patient Outcome at 28 Days
Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome
Measured: 28 days
Renal Failure
Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
Measured: 28 days
Liver Failure
Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%
Measured: 28 days
Cytokine Storm
Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
Measured: 28 days
Respiratory Support
Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.
Measured: 28 days
Vasopressor Medication Support
Count of participants who received pressor drugs, as ordered by treating physicians
Measured: 28 days
Length of ICU Length of Stay
Length of ICU stay in days, for participants who entered ICU
Measured: 28 days
Intensive Care Unit (ICU) Mortality
Count of patients admitted to the ICU who die in ICU
Measured: 28 days
Hospital Length of Stay
Length of hospital stay in days
Measured: 28 days
Ventilator Free Days
Number of ventilator-free hospitalized days
Measured: 28 days
Intubation Duration
Length of intubation, measured in days
Measured: 28 days
Readmission
Count of participants readmitted to hospital following index procedure hospital discharge
Measured: 90 days
Serum Anti-SARS-CoV-2 IgG
Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.
Measured: During hospitalization, a maximum of 28 days
SARS-CoV-2 RNA
Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.
Measured: During hospitalization, a maximum of 28 days
Mortality (Group A)
Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die
Measured: 28 days
Time From Transfusion to End of Ventilator Support (Group B)
Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)
Measured: During hospitalization, a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start16 Jul 2020
- Primary completion13 Nov 2020
- Study completion28 Nov 2020
Why it stopped: The EUA for CCP was updated by FDA, stipulating that only high titer units be used. This study required untitered units. The study became infeasible
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.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single health system, non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Sims, MD, PhD, Corewell Health East
- Investigators
- Matthew Sims, MD PhD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432272
- Sponsor's protocol ID
- 2020-198
- Acronym
- ABACCuS
- Status last verified
- Mar 2022
- First submitted
- 12 Jun 2020
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
- ClinicalTrials.gov ID
- NCT04432272
- Acronym / sponsor ID
- ABACCuS / 2020-198
- Keywords
- therapeutic treatment, COVID-19 convalescent plasma, anti-SARS-CoV-2 antibody, IgA, IgG, COVID-19 pandemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The EUA for CCP was updated by FDA, stipulating that only high titer units be used. This study required untitered units. The study became infeasible
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 22 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma.
A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study.
Participants will be assigned to a study group depending on how sick they are.
- Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator
- Group B: Those who require a ventilator to preserve their life.
Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
Detailed description
This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria). Participants in both group A and group B will receive COVID-19 convalescent plasma. Group A will include hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain O2 saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. Group B will include hospitalized COVID-19 patients ages ≥18 years requiring intubation. Patients may be enrolled in group A within 14 days of admission to the hospital and may be enrolled in group B at any time after intubation. A total of 300 eligible subjects with significant oxygen requirements and 200 eligible subjects who require intubation will be included in the study. They will receive convalescent plasma from either a patient who has recovered from COVID-19 or from an asymptomatic carrier with confirmed Immunoglobulin-G (IgG) antibodies against SARS-CoV-2. Subjects will not be randomized. The amount of anti-SARS-CoV-2 IgG and Immunoglobulin-A (IgA) antibodies in any unit of plasma will not be known when the unit is assigned to the patient. This will allow us to examine the relationship between the amount of anti-SARS-CoV-2 antibody and outcomes. Analysis will be based on measurement of optical density of the IgG level in the unit of plasma the patient is randomly supplied by the blood bank. While investigators and patients will be aware the patient is receiving a unit of COVID-19 convalescent plasma, both the investigators and the patients will be blinded to the antibody content of that unit.
COVID-19 convalescent plasma (1 unit; ~200mL) will be produced by a blood bank licensed to produce plasma using standard screening and safety procedures. The product may be procured from patients who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA.
Participants at the eight Michigan hospitals comprising the Beaumont Health system may be eligible to participate. Study oversight and coordination will occur centrally, from the Infectious Disease Research Department at Beaumont's Royal Oak campus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single health system, non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: COVID-19 convalescent plasmaHospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. |
| Group B | Experimental | Biological: COVID-19 convalescent plasmaHospitalized COVID-19 patients ages ≥18 years requiring intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be 18 years of age or older.
- Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2 Reverse-transcription polymerase chain reaction (RT-PCR) testing.
- Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of breath) at time of screening.
- Patient requires >6 L nasal cannula oxygen (Group A) or intubated (Group B).
- Patient (or their legal authorized representative) is willing and able to provide written informed consent and comply with all protocol requirements.
Key exclusion criteria (6 listed)
- For patients in Group A admitted for >14 days
- Female subjects with positive pregnancy test, breastfeeding, or planning to become --pregnant or breastfeed during the study period.
- Receipt of pooled immunoglobulin in past 30 days.
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Patients currently undergoing cancer treatment or those who are presently immunocompromised.
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 |
|---|---|---|
| COVID-19 convalescent plasmaParticipants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit | Biological | Group A, Group B |
Primary outcome
Avoidance of Intubation at 28 Days (Group A)
Time frame: 28 days
Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated
Mortality (Group B)
Time frame: 28 days
Count of group B participants (participants who are intubated at study entry) who die
17 secondary outcomes
Cardio-circulatory Arrest
Time frame: 28 days
Patient Outcome at 28 Days
Time frame: 28 days
Renal Failure
Time frame: 28 days
Liver Failure
Time frame: 28 days
Cytokine Storm
Time frame: 28 days
Respiratory Support
Time frame: 28 days
Vasopressor Medication Support
Time frame: 28 days
Length of ICU Length of Stay
Time frame: 28 days
Intensive Care Unit (ICU) Mortality
Time frame: 28 days
Hospital Length of Stay
Time frame: 28 days
Ventilator Free Days
Time frame: 28 days
Intubation Duration
Time frame: 28 days
Readmission
Time frame: 90 days
Serum Anti-SARS-CoV-2 IgG
Time frame: During hospitalization, a maximum of 28 days
SARS-CoV-2 RNA
Time frame: During hospitalization, a maximum of 28 days
Mortality (Group A)
Time frame: 28 days
Time From Transfusion to End of Ventilator Support (Group B)
Time frame: During hospitalization, a maximum of 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Matthew Sims, MD PhD principal investigator
Beaumont Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 convalescent plasma in people with COVID-19 and Severe Acute Respiratory Syndrome (SARS), run by Corewell Health East at 1 site 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 22 Nov 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?
Avoidance of Intubation at 28 Days (Group A) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 9 Mar 2022.