A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: RBT-9 (90 mg)
* Drug: 0.9% sodium chloride (normal saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥18 years of age at Screening. Confirmed infection with SARS-CoV-2. High risk of COVID-19 disease progression, defined as: 18-69 years of age with lymphopenia AND 1 additional risk factor (described below) 18-69 years of age without lymphopenia AND 2 risk factors (described below) ≥70 years of age with lymphopenia OR 1 other risk factor (described below) Risk Factors: Documented history of coronary artery disease Heart failure (New York Heart Association Class 3 or 4) Chronic lung disease (eg, asthma or chronic obstructive pulmonary disease) requiring treatment Documented history of stroke Diabetes mellitus, requiring at least 1 prescription medicine for management Documented chronic kidney disease with an estimated glomerular filtration rate <30 mL/min, not on dialysis Obesity (Class 2 or 3; body mass index >34.9 kg/m2) On immunosuppressive therapy Oxygen saturation between 90 and 95% with or without supplemental oxygen 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). 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. For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit. 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. Must be willing and able to give informed consent and comply with all study procedures. Exclusion Criteria: Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours. 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. Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening. Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening. Requires non-invasive ventilation at the time of Screening. Requires dialysis at the time of Screening. 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. Pregnant or lactating. History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9. Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product. Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug. Inability to comply with the requirements of the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 randomization to receive RBT-9:Placebo
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBT-9 (90 mg)<br>RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. | Drug: RBT-9 (90 mg)<br>* Subjects will receive a single dose and study duration will be approximately 60 days per subject.<br>|
| Placebo Comparator: Placebo<br>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)<br>* Subjects will receive a single dose and study duration will be approximately 60 days per subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | baseline and 7 days, baseline and 28 days |