COVID-19Phase 2NCT04547140
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
A Phase 2 study testing Liquid Alpha1-Proteinase Inhibitor (Human) and Standard Medical Treatment in people with COVID-19, run by Grifols Therapeutics LLC at 20 sites in 5 countries.
Trial summary
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Liquid Alpha1-Proteinase Inhibitor (Human) and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 29 Jan 2021to 28 Jan 2022
- 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
- Hospitalized male or female participant ≥ 18 years of age at time of screening who is being treated for COVID-19. Participants must be screened within 48 hours (≤ 48 hours) of hospital admission.
- Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for COVID-19 in any specimen during the current hospital admission OR 96 hours prior to the hospital admission date and prior to randomization (the SARS-CoV-2 test results must be performed by a hospital laboratory and the documentation available).
- COVID-19 illness (symptoms) of any duration, including both of the following: a) Radiographic infiltrates by imaging (chest X-Ray, computed tomography (CT) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air; b) Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L).
- Participant provides informed consent prior to initiation of any study procedures.
- Female participants of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
Who cannot join
- Participants requiring invasive mechanical ventilation or ICU admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FIO2) ≤ 150 mmHg (i.e., arterial oxygen in millimeter of mercury (mmHg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]).
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk.
- The participant has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- A medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
- Known alpha-1 antitrypsin deficiency for which the participant is already receiving alpha1-proteinase inhibitor augmentation therapy.
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- Women who are pregnant or breastfeeding. Female participants of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at screening/baseline visit.
- Participants for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
- Currently participating in another interventional clinical trial with investigational medical product or device.
- Participants previously requiring long-term oxygen therapy (home oxygen therapy).
- History (within the last 2 years) of myocardial infarction, unstable angina, stroke or transient ischemic attacks, pulmonary embolism or deep venous thrombosis.
- Participant has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
- Systolic blood pressure < 100 mm Hg or > 160 mm Hg (uncontrolled hypertension) at the time of Screening.
- Alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal (ULN).
- Any elevation of total bilirubin at the time of Screening.
- Estimated glomerular filtration rate (eGFR) < 45 mL/min (or participant is dependent on dialysis/renal replacement therapy) at the time of Screening. eGFR is calculated by the Cockcroft-Gault equation.
- Hemoglobin < 10 g/dL at the time of Screening.
- Absolute neutrophil count < 1000/mm^3 at the time of Screening.
- Platelet count < 75,000/mm^3 at the time of Screening.
- Participant has history of drug or alcohol abuse within the past 24 months.
- Participant is unwilling to commit to follow-up visits.
- Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States10 sites
Birmingham VA
Birmingham, Alabama, 35233
Hannibal Clinic
Hannibal, Missouri, 63401
Kansas City VA
Kansas City, Missouri, 64128
Sparrow Hospital
Lansing, Michigan, 48912
Memphis VA
Memphis, Tennessee, 38104
University of Miami Hospital
Miami, Florida, 33125
Columbia University Medical Center
New York, New York, 10032
CHI Health Center
Omaha, Nebraska, 68102
St. Joseph's Hospital
Phoenix, Arizona, 85013
University of Utah
Salt Lake City, Utah, 84108
Brazil6 sites
AngioCor Blumenau
Blumenau, Santa Catarina, 89020-430
Hospital Dia do Pulmão
Blumenau, 89030-101
Universidade Estadual São Paulo - Campus de Botucatu
Botucatu, São Paulo, 18618-686
Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, 88811-500
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001
Universidade Federal de Sao Paulo
São Paulo, 04037-002
Chile2 sites
Hospital Padre Hurtado
Santiago, 8860000
Hospital Carlos Van Buren
Valparaíso, 2340000
Colombia1 site
Fundación Oftalmológica de Santander
Bucaramanga, Santander Department
Mexico1 site
Unidad Medica para la Salud Integral
San Nicolás de los Garza, 66465
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.
- Conditions
- COVID-19
- Being tested
- Liquid Alpha1-Proteinase Inhibitor (Human), Placebo, Standard Medical Treatment
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Alpha1-Proteinase Inhibitor (Human)Biological
Also called Alpha1-proteinase inhibitor
Intravenous infusion 120 mg/kg
PlaceboDrug
Also called 0.9% Normal Saline
Intravenous infusion
Standard Medical TreatmentDrug
SMT
| Study group | Role | What they receive |
|---|---|---|
| Liquid Alpha1-Proteinase Inhibitor + Standard Medical Treatment | Experimental | Participants received the first intravenous (IV) infusion of liquid alpha1-proteinase inhibitor (human) 120 milligrams per kilogram (mg/kg), based on body weight on Day 1, followed by second liquid alpha1-proteinase inhibitor (human) dose of 120 mg/kg based on body weight, on Day 8 (second dose was not mandatory and was given at the principal investigator's [PI] discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29. Receives: Biological: Liquid Alpha1-Proteinase Inhibitor (Human); Drug: Standard Medical Treatment |
| Placebo + Standard Medical Treatment | Placebo comparator | Participants received IV infusions of 0.9% normal saline of commensurate volume to that of liquid alpha1-proteinase inhibitor as placebo on Day 1 and Day 8 (Day 8 was not mandatory and was given at the PI's discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29. Receives: Drug: Placebo; Drug: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Dying or Requiring Intensive Care Unit (ICU) Admission
Measured: Up to Day 29
Percentage of Participants Who Are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation
Measured: Day 29
Secondary outcomes (13)
Change From Baseline in National Early Warning Score (NEWS)
NEWS is clinical scoring developed to improve detection of deterioration in ill participant. It is based on 7 clinical parameters: Respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure (BP), pulse rate, level of consciousness, and temperature. A score of 0 and 2 was allocated to supplemental oxygen, 0 and 3 for level of consciousness and score of 0, 1, 2 and 3 for remaining parameters (i.e. respiration rate, oxygen saturation, systolic BP, pulse rate and temperature) where 0 = normal health condition to 3 = worst health condition; Higher scores indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 20, with higher scores indicating more severity/higher risk.
Measured: Baseline, Days 15 and 29
Time to Clinical Response as Assessed by NEWS Score ≤ 2 Maintained for 24 Hours
Time to clinical response was reported at 50th percentile in days.
Measured: Up to Day 29
Time to Hospital Discharge
Time to hospital discharge is defined as duration of hospitalization from Day 1 through Day 29.
Measured: Up to Day 29
Duration of ICU Stay
Duration of ICU stay in days is analyzed for participants admitted to ICU post randomization.
Measured: Up to Day 29
Duration of Any Oxygen Use
Measured: Up to Day 30
Duration of Mechanical Ventilation
Duration of Mechanical Ventilation is analyzed for participants requiring mechanical ventilation post randomization.
Measured: Up to Day 29
Mean Change From Baseline in Ordinal Scale
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness. Mean change in Ordinal scale was evaluated by fitting a linear mixed-effects model for repeated measures (MMRM).
Measured: Baseline, Days 15 and 29
Absolute Change From Baseline in Ordinal Scale
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness.
Measured: Baseline, Days 15 and 29
Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. The percentages are rounded off to the single decimal point.
Measured: Day 15 and Day 29
Time to Sustained Normalization of Temperature
Time to sustained normalization of temperature was reported at 50th percentile in days.
Measured: Up to Day 29
Percentage of Participants Who Experienced Sustained Normalization of Fever
Normalization of fever is defined as temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours.
Measured: Up to Day 29
Number of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
ARDS was defined based on Berlin criteria (chest imaging, origin of edema, oxygenation).
Measured: Up to Day 29
Time to Clinical Progression
Time to clinical progression is defined as the time to death, mechanical ventilation, or ICU admission. Time to clinical progression was reported at 50th percentile in days.
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start29 Jan 2021
- Primary completion13 Dec 2021
- Study completion28 Jan 2022
Why it stopped: Study Stopped for Futility
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547140
- Sponsor's protocol ID
- GC2006
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2020
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19
- ClinicalTrials.gov ID
- NCT04547140
- Acronym / sponsor ID
- GC2006
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Stopped for Futility
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 22 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Alpha1-Proteinase Inhibitor + Standard Medical Treatment | Experimental | Biological: Liquid Alpha1-Proteinase Inhibitor (Human), Drug: Standard Medical TreatmentParticipants received the first intravenous (IV) infusion of liquid alpha1-proteinase inhibitor (human) 120 milligrams per kilogram (mg/kg), based on body weight on Day 1, followed by second liquid alpha1-proteinase inhibitor (human) dose of 120 mg/kg based on body weight, on Day 8 (second dose was not mandatory and was given at the principal investigator's [PI] discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Placebo + Standard Medical Treatment | Placebo comparator | Drug: Placebo, Drug: Standard Medical TreatmentParticipants received IV infusions of 0.9% normal saline of commensurate volume to that of liquid alpha1-proteinase inhibitor as placebo on Day 1 and Day 8 (Day 8 was not mandatory and was given at the PI's discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized male or female participant ≥ 18 years of age at time of screening who is being treated for COVID-19. Participants must be screened within 48 hours (≤ 48 hours) of hospital admission.
- Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for COVID-19 in any specimen during the current hospital admission OR 96 hours prior to the hospital admission date and prior to randomization (the SARS-CoV-2 test results must be performed by a hospital laboratory and the documentation available).
- COVID-19 illness (symptoms) of any duration, including both of the following: a) Radiographic infiltrates by imaging (chest X-Ray, computed tomography (CT) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air; b) Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L).
- Participant provides informed consent prior to initiation of any study procedures.
- Female participants of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
Key exclusion criteria (22 listed)
- Participants requiring invasive mechanical ventilation or ICU admission or with partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FIO2) ≤ 150 mmHg (i.e., arterial oxygen in millimeter of mercury (mmHg) divided by fraction inspired oxygen concentration [example, 0.21 for room air]).
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk.
- The participant has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- A medical condition in which the infusion of additional fluid is contraindicated (example, decompensated congestive heart failure or renal failure with fluid overload). This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal 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 |
|---|---|---|
| Liquid Alpha1-Proteinase Inhibitor (Human)Also: Alpha1-proteinase inhibitorIntravenous infusion 120 mg/kg | Biological | Liquid Alpha1-Proteinase Inhibitor + Standard Medical Treatment |
| PlaceboAlso: 0.9% Normal SalineIntravenous infusion | Drug | Placebo + Standard Medical Treatment |
| Standard Medical TreatmentSMT | Drug | Liquid Alpha1-Proteinase Inhibitor + Standard Medical Treatment, Placebo + Standard Medical Treatment |
Primary outcome
Percentage of Participants Dying or Requiring Intensive Care Unit (ICU) Admission
Time frame: Up to Day 29
Percentage of Participants Who Are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation
Time frame: Day 29
13 secondary outcomes
Change From Baseline in National Early Warning Score (NEWS)
Time frame: Baseline, Days 15 and 29
Time to Clinical Response as Assessed by NEWS Score ≤ 2 Maintained for 24 Hours
Time frame: Up to Day 29
Time to Hospital Discharge
Time frame: Up to Day 29
Duration of ICU Stay
Time frame: Up to Day 29
Duration of Any Oxygen Use
Time frame: Up to Day 30
Duration of Mechanical Ventilation
Time frame: Up to Day 29
Mean Change From Baseline in Ordinal Scale
Time frame: Baseline, Days 15 and 29
Absolute Change From Baseline in Ordinal Scale
Time frame: Baseline, Days 15 and 29
Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale
Time frame: Day 15 and Day 29
Time to Sustained Normalization of Temperature
Time frame: Up to Day 29
Percentage of Participants Who Experienced Sustained Normalization of Fever
Time frame: Up to Day 29
Number of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Time frame: Up to Day 29
Time to Clinical Progression
Time frame: Up to Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liquid Alpha1-Proteinase Inhibitor (Human) and Standard Medical Treatment in people with COVID-19, run by Grifols Therapeutics LLC at 20 sites in 5 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 5 inclusion and 22 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Brazil, Chile, Colombia, Mexico. 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 22 Mar 2023). 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 Dying or Requiring Intensive Care Unit (ICU) Admission (time frame: Up to Day 29). 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 22 Mar 2023.