COVID-19Phase 2NCT04784897
A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
A Phase 2 study testing Brilacidin in people with COVID-19, run by Innovation Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Brilacidin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Feb 2021to 30 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written Informed Consent Form (ICF) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative.
- Male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent.
- SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization.
- Currently hospitalized and requiring medical care for COVID-19.
- Moderate OR severe COVID-19, defined by respiratory function at screening, as below:
- Moderate, meets at least one of the following criteria:
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- Peripheral oxygen saturation SpO2 > 93% on room air;
- Respiratory rate ≥ 20 to < 30 breaths per minute.
- Severe, meets at least one of the following criteria:
- Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) [corrective formulation should be used for higher altitude regions (over 1000m)];
- Respiratory rate ≥ 30 breaths per minute.
- Body mass index (BMI) of ≥18 to <40kg/m2 at screening.
- Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
- In the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.
Who cannot join
- Participation in any other clinical trial of an experimental agent treatment.
- Requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) at the time of randomization.
- Has explicitly expressed the wish not to receive intensive care support (Do not resuscitate or Do not intubate order) should this become necessary.
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure.
- Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
- Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines.
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- If has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines.
- Evidence of moderate or severe hepatic impairment (Child-Pugh Class B or C).
- Estimated GFR (eGFR) <30 mL/min/1.73m2 (based on CKD-EPI formula).
- Prior to a participant's study entry, known allergies or intolerance to Brilacidin or formulation excipients.
- Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
- Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.
- Sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Russia10 sites
IPI Investigator Site
Barnaul, 656045
IPI Investigator Site
Moscow, 111398
IPI Investigator Site
Moscow, 119048
IPI Investigator Site
Moscow, 121359
IPI Investigator Site
Moscow, 125367
IPI Investigator Site
Nizniy Novgorod, 603155
IPI Investigator Site
Pushkin, 196600
IPI Investigator Site
Saint Petersburg, 198205
IPI Investigator Site
Saint Petersburg, 198510
IPI Investigator Site
Saint Petersburg, 199106
United States2 sites
IPI Investigator Site
Toledo, Ohio, 43608
IPI Investigator Site
Winfield, Illinois, 60190
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants
Read the detailed description
This Phase 2 study was a randomized, blinded, placebo-controlled, parallel group design.
The target population treated were patients with moderate to severe COVID-19, active SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and were hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.
For each participant, the study was comprised of three parts:
- Screening/ Baseline visit (Day -1 to 1): Lasting up to 24-48 hours and comprised screening/ baseline assessments. This visit was to confirm that study inclusion and exclusion criteria were met by participants prior to randomization.
- Treatment period (Day 1-3 or Day 1-5): Randomized subjects received blinded study treatment once daily for 3 or 5 days by IV infusion, in addition to Standard of Care (SoC).
- Follow-up period (Day 4 or 6 through Day 60): Subjects were assessed daily while hospitalized. Discharged patients were asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, was performed to confirm patient status.
All participants had a series of efficacy and safety assessments performed, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs were also obtained (oropharyngeal (OP) swabs were to be collected only in exceptional circumstances).
Study participants/subjects were randomized to active or placebo, and the study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing was extended to 5 days. Hence, subjects recruited after the interim analysis received 5 days of study treatment.
For study analyses, subjects randomized to placebo were pooled since duration of placebo should not impact efficacy or safety outcomes. As the different treatment durations for Brilacidin have potential to impact efficacy and/or safety outcomes, 3-dose and 5-dose active arms were analyzed separately.
- Conditions
- COVID-19
- Being tested
- Brilacidin, Placebo, Standard of Care (SoC)
- Keywords
- SARS-CoV-2, coronavirus, Brilacidin, COVID-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrilacidinDrug
Brilacidin IV infusion
PlaceboDrug
Placebo IV infusion
Standard of Care (SoC)Drug
SoC therapies for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Brilacidin + SoC | Experimental | Brilacidin IV infusion, 3 days and up to 5 days, in addition to Standard of Care Receives: Drug: Brilacidin; Drug: Standard of Care (SoC) |
| Placebo + SoC | Placebo comparator | Placebo IV infusion, 3 days and up to 5 days, in addition to Standard of Care Receives: Drug: Placebo; Drug: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sustained Recovery Through Day 29
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the clinical status ordinal scale with response sustained through Day 29:
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities
Measured: Day 1 through Day 29
Percentage of Participants With Sustained Recovery Through Day 29
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the clinical status ordinal scale with response sustained through Day 29:
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities
Measured: Day 5, Day 8, Day 11, Day 15, Day 29
Secondary outcomes (12)
Number and Percentage of Participants Achieving Recovery Status Scores at Day 29
Recovery status scores are the following three categories from the clinical status ordinal scale:
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities
Measured: Day 29
Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29
Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)
Measured: Day 1 through Day 29
Subject Clinical Status
Clinical status was measured with an 8-point ordinal scale:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low-flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 1, Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status
Clinical status was measured with an 8-point ordinal scale:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low-flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status
Clinical status was measured with an 8-point ordinal scale:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low-flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 8, Day 15, Day 29
Time to at Least One Category Improvement in Clinical Status
Day to achieving improvement of one or more category on 8-point clinical status ordinal scale.
Clinical status scale:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low-flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 1 through Day 29
Time to at Least Two Category Improvement in Clinical Status
Day to achieving improvement of two or more categories on 8-point clinical status ordinal scale.
Clinical status scale:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring low-flow supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 1 through Day 29
Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
Time (in days) from randomization to achieve a NEWS2 score lower or equal to 2 being maintained for at least one 24-hour period.
NEWS2 was assessed twice daily while hospitalized; if one of the components of the NEWS2 was missing at a particular time point, the NEWS2 was not calculated.
The National Early Warning Score 2 (NEWS2) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 [alert, normal health condition] or 3 [altered mental state/confusion, worst health condition]). All parameter scores were summed to get an aggregate NEWS2. NEWS2 ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk
Measured: Day 1 through Day 29
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
The National Early Warning Score 2 (NEWS2) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of seven (7) clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 [alert, normal health condition] or 3 [altered mental state/confusion, worst health condition]). All parameter scores were summed to get an aggregate NEWS2 assessment. Scoring for NEWS2 ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk: low risk (score 1 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 20).
Measured: Day 5, Day 8, Day 11, Day 15
Change From Baseline in National Early Warning Score 2 (NEWS2)
The National Early Warning Score 2 (NEWS2) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of seven (7) clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 [alert, normal health condition] or 3 [altered mental state/confusion, worst health condition]). All parameter scores were summed to get an aggregate NEWS2 assessment. Scoring for NEWS2 ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk: low risk (score 1 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 20).
Measured: Day 1 through Day 29
Number and Percentage of Participants With Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
Measured: Day 1 through Day 60
Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest
Treatment-Emergent adverse events have onset dates on or after the study treatment start date.
Adverse Events of Special Interest (AESIs) are (i) hypertension Grade 3 or greater, and (ii) paresthesias / dysesthesias Grade 2 or greater, in accordance with CTCAE (version 5.0) criteria.
Measured: Day 1 through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start22 Feb 2021
- Primary completion1 Jul 2021
- Study completion30 Jul 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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Innovation Pharmaceuticals Inc., Study director, Innovation Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784897
- Sponsor's protocol ID
- IPI-BRIc-201
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2021
- Last updated
- 16 Sep 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
- ClinicalTrials.gov ID
- NCT04784897
- Acronym / sponsor ID
- IPI-BRIc-201
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, coronavirus, Brilacidin, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Innovation Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Posted 16 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants
Detailed description
This Phase 2 study was a randomized, blinded, placebo-controlled, parallel group design.
The target population treated were patients with moderate to severe COVID-19, active SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and were hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.
For each participant, the study was comprised of three parts:
- Screening/ Baseline visit (Day -1 to 1): Lasting up to 24-48 hours and comprised screening/ baseline assessments. This visit was to confirm that study inclusion and exclusion criteria were met by participants prior to randomization.
- Treatment period (Day 1-3 or Day 1-5): Randomized subjects received blinded study treatment once daily for 3 or 5 days by IV infusion, in addition to Standard of Care (SoC).
- Follow-up period (Day 4 or 6 through Day 60): Subjects were assessed daily while hospitalized. Discharged patients were asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, was performed to confirm patient status.
All participants had a series of efficacy and safety assessments performed, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs were also obtained (oropharyngeal (OP) swabs were to be collected only in exceptional circumstances).
Study participants/subjects were randomized to active or placebo, and the study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing was extended to 5 days. Hence, subjects recruited after the interim analysis received 5 days of study treatment.
For study analyses, subjects randomized to placebo were pooled since duration of placebo should not impact efficacy or safety outcomes. As the different treatment durations for Brilacidin have potential to impact efficacy and/or safety outcomes, 3-dose and 5-dose active arms were analyzed separately.
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 |
|---|---|---|
| Brilacidin + SoC | Experimental | Drug: Brilacidin, Drug: Standard of Care (SoC)Brilacidin IV infusion, 3 days and up to 5 days, in addition to Standard of Care |
| Placebo + SoC | Placebo comparator | Drug: Placebo, Drug: Standard of Care (SoC)Placebo IV infusion, 3 days and up to 5 days, in addition to Standard of Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed and dated written Informed Consent Form (ICF) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative.
- Male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent.
- SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization.
- Currently hospitalized and requiring medical care for COVID-19.
- Moderate OR severe COVID-19, defined by respiratory function at screening, as below:
Key exclusion criteria (14 listed)
- Participation in any other clinical trial of an experimental agent treatment.
- Requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) at the time of randomization.
- Has explicitly expressed the wish not to receive intensive care support (Do not resuscitate or Do not intubate order) should this become necessary.
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure.
- Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
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 |
|---|---|---|
| BrilacidinBrilacidin IV infusion | Drug | Brilacidin + SoC |
| PlaceboPlacebo IV infusion | Drug | Placebo + SoC |
| Standard of Care (SoC)SoC therapies for COVID-19 | Drug | Brilacidin + SoC, Placebo + SoC |
Primary outcome
Time to Sustained Recovery Through Day 29
Time frame: Day 1 through Day 29
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the clinical status ordinal scale with response sustained through Day 29: 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities
Percentage of Participants With Sustained Recovery Through Day 29
Time frame: Day 5, Day 8, Day 11, Day 15, Day 29
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the clinical status ordinal scale with response sustained through Day 29: 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities
12 secondary outcomes
Number and Percentage of Participants Achieving Recovery Status Scores at Day 29
Time frame: Day 29
Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29
Time frame: Day 1 through Day 29
Subject Clinical Status
Time frame: Day 1, Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status
Time frame: Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status
Time frame: Day 8, Day 15, Day 29
Time to at Least One Category Improvement in Clinical Status
Time frame: Day 1 through Day 29
Time to at Least Two Category Improvement in Clinical Status
Time frame: Day 1 through Day 29
Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
Time frame: Day 1 through Day 29
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
Time frame: Day 5, Day 8, Day 11, Day 15
Change From Baseline in National Early Warning Score 2 (NEWS2)
Time frame: Day 1 through Day 29
Number and Percentage of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 through Day 60
Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest
Time frame: Day 1 through Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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.
Innovation Pharmaceuticals Inc. study director
Innovation Pharmaceuticals, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brilacidin in people with COVID-19, run by Innovation Pharmaceuticals, Inc. at 12 sites in 2 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 14 inclusion and 14 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia, 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 16 Sep 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?
Time to Sustained Recovery Through Day 29 (time frame: Day 1 through 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 16 Sep 2022.