Phase 2
Completed N=120
A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
Source: ClinicalTrials.gov NCT04784897 ↗Enrolled (actual)
120
Serious AEs
11.7%
Results posted
Sep 2022
Primary outcomePrimary: Time to Sustained Recovery Through Day 29 — 12.00; 13.00; 13.00 days — p=0.7273
Summary
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Recovery Through Day 29 |
12.00; 13.00; 13.00 | 0.7273 |
| PRIMARY Percentage of Participants With Sustained Recovery Through Day 29 |
8.33; 6.25; 4.55; 25.00; 18.75; 20.45 | — |
| SECONDARY Number and Percentage of Participants Achieving Recovery Status Scores at Day 29 |
54; 14; 41 | — |
| SECONDARY Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29 |
3; 2; 2 | — |
| SECONDARY Subject Clinical Status |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status |
30; 6; 20; 44; 12; 35 | — |
| SECONDARY Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status |
16; 3; 10; 39; 9; 27 | — |
| SECONDARY Time to at Least One Category Improvement in Clinical Status |
7.00; 10.00; 8.00 | — |
| SECONDARY Time to at Least Two Category Improvement in Clinical Status |
12.50; 14.00; 13.00 | — |
| SECONDARY Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours |
3.00; 3.00; 3.00 | — |
| SECONDARY Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours |
65.62; 72.73; 62.07; 78.12; 72.73; 84.83 | — |
| SECONDARY Change From Baseline in National Early Warning Score 2 (NEWS2) |
-0.433; -1.000; -0.682; -1.150; -1.500; -1.455 | — |
| SECONDARY Number and Percentage of Participants With Treatment-Emergent Adverse Events |
39; 14; 39; 9; 6; 7 | — |
| SECONDARY Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest |
2; 3; 2; 0; 3; 4 | — |
Eligibility Criteria
Inclusion Criteria
- 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:
- Peripheral oxygen saturation SpO2 > 93% on room air;
- Respiratory rate ≥ 20 to 220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines.
- 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.
Data sourced from ClinicalTrials.gov (NCT04784897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.