A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
Study Details
Study Description
Brief Summary
The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RBT-9 (90 mg) RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. |
Drug: RBT-9 (90 mg)
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
|
| Placebo Comparator: Placebo 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. |
Drug: 0.9% sodium chloride (normal saline)
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
|
Outcome Measures
Primary Outcome Measures
- Evaluate the effect of RBT-9 versus placebo on clinical status of COVID-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale [28 days]
Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which measures the clinical status of a subject at the first assessment of a given day with category 1, most favorable, and category 8, least favorable (1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support - pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]; 8. Death)
Secondary Outcome Measures
- Time to first occurrence of death from any cause or new/worsened organ dysfunction [28 Days]
Time to first occurrence of either death from any cause or new/worsened organ dysfunction through Day 28, defined as at least one of the following: 1. Respiratory decompensation; 2. New or worsening congestive heart failure; 3. Requirement of vasopressor therapy and/or inotropic or mechanical circulatory support; 4. Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest; 5. Initiation of renal replacement therapy
- All-cause survival [28 Days]
Percentage of subjects who are alive at Day 28
- Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio [28 Days]
Among subjects who begin oxygen therapy, mean change from initiation to last day on oxygen or Day 28 (whichever happens first) in SpO2/FiO2 ratio
- Fever incidence [28 Days]
Percentage of subjects with fever through Day 28
- Acute kidney injury (AKI) incidence [28 Days]
Percentage of subjects who develop AKI (defined as an increase in serum creatinine by 0.5 mg/dL or more within 48 hours or an increase in serum creatinine to 1.5 × Baseline or more within the last 7 days) through Day 28
- New or worsening congestive heart failure (HF) [28 Days]
Percentage of subjects with new or worsening congestive HF through Day 28
- Hospitalization status [28 Days]
Percentage of subjects who remain hospitalized at Day 28
- Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest [28 Days]
Percentage of subjects with ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest through Day 28
- Oxygen-free days [28 Days]
Number of oxygen-free days through Day 28
- Intensive care unit (ICU) status [28 Days]
Percentage of subjects transferred to the ICU through Day 28
- Days on ventilator [28 Days]
Number of days on mechanical ventilation through Day 28
- Time to and duration of vasopressor or inotrope utilization [28 Days]
Time to and duration of vasopressor or inotrope utilization through Day 28
- Dialysis status [28 Days]
Percentage of subjects who begin dialysis through Day 28
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, ≥18 years of age at Screening.
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Confirmed infection with SARS-CoV-2.
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High risk of COVID-19 disease progression, defined as:
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18-69 years of age with lymphopenia AND 1 additional risk factor (described below)
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18-69 years of age without lymphopenia AND 2 risk factors (described below)
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≥70 years of age with lymphopenia OR 1 other risk factor (described below)
Risk Factors:
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Documented history of coronary artery disease
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Heart failure (New York Heart Association Class 3 or 4)
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Chronic lung disease (eg, asthma or chronic obstructive pulmonary disease) requiring treatment
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Documented history of stroke
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Diabetes mellitus, requiring at least 1 prescription medicine for management
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Documented chronic kidney disease with an estimated glomerular filtration rate <30 mL/min, not on dialysis
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Obesity (Class 2 or 3; body mass index >34.9 kg/m2)
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On immunosuppressive therapy
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Oxygen saturation between 90 and 95% with or without supplemental oxygen
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Admitted to a hospital for observation and/or treatment (controlled facility may include an emergency room, urgent care facility, temporary/modular hospital, infusion center, clinical research unit, etc).
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If female, must be postmenopausal, surgically sterile, or if of childbearing potential, must be practicing 2 effective methods of birth control during the study and through 30 days after completion of the study.
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For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit.
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If male, must be surgically sterile or willing to practice 2 effective methods of birth control during the study and through 30 days after completion of the study.
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Must be willing and able to give informed consent and comply with all study procedures.
Exclusion Criteria:
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Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours.
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Evidence of acute cardiac injury, as determined by the Investigator at the time of Screening. This may be based upon clinical signs and symptoms, ECG findings, or elevated troponin I levels.
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Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening.
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Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening.
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Requires non-invasive ventilation at the time of Screening.
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Requires dialysis at the time of Screening.
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Has received or is receiving anti-IL-6 therapies (eg, Tocilizumab, Sarilumab, Siltuximab, etc) for the treatment of COVID-19; subjects receiving anti-IL-6 therapies for underlying medical conditions unrelated to COVID-19 are not excluded from eligibility.
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Pregnant or lactating.
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History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9.
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Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product.
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Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug.
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Inability to comply with the requirements of the study protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Smyrna Beach, FL | New Smyrna Beach | Florida | United States | 32168 |
| 2 | Berkley, MI | Berkley | Michigan | United States | 48072 |
| 3 | El Paso, TX | El Paso | Texas | United States | 79935 |
| 4 | Fort Worth, TX | Fort Worth | Texas | United States | 76104 |
| 5 | Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Renibus Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REN-005