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

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ClinicalTrials.gov Identifier: NCT04364763
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Renibus Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 20, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE August 5, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
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 [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
Evaluate the effect of RBT-9 (Stannous Protoporphyrin) versus placebo on clinical status of COVID-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale [ Time Frame: 28 days ]
Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Time to first occurrence of death from any cause or new/worsened organ dysfunction [ Time Frame: 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 [ Time Frame: 28 Days ]
    Percentage of subjects who are alive at Day 28
  • Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio [ Time Frame: 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 [ Time Frame: 28 Days ]
    Percentage of subjects with fever through Day 28
  • Acute kidney injury (AKI) incidence [ Time Frame: 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) [ Time Frame: 28 Days ]
    Percentage of subjects with new or worsening congestive HF through Day 28
  • Hospitalization status [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28 Days ]
    Number of oxygen-free days through Day 28
  • Intensive care unit (ICU) status [ Time Frame: 28 Days ]
    Percentage of subjects transferred to the ICU through Day 28
  • Days on ventilator [ Time Frame: 28 Days ]
    Number of days on mechanical ventilation through Day 28
  • Time to and duration of vasopressor or inotrope utilization [ Time Frame: 28 Days ]
    Time to and duration of vasopressor or inotrope utilization through Day 28
  • Dialysis status [ Time Frame: 28 Days ]
    Percentage of subjects who begin dialysis through Day 28
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • Time to first occurrence of death from any cause or new/worsened organ dysfunction [ Time Frame: 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 [ Time Frame: 28 Days ]
    Percentage of subjects who are alive at Day 28
  • Respiratory distress rate [ Time Frame: 28 Days ]
    Among subjects who begin oxygen therapy, mean change from initiation to last day on oxygen or Day 28 (whichever happens first) in respiratory distress rate
  • Fever incidence [ Time Frame: 28 Days ]
    Percentage of subjects with fever through Day 28
  • Acute kidney injury (AKI) incidence [ Time Frame: 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) [ Time Frame: 28 Days ]
    Percentage of subjects with new or worsening congestive HF at Day 28
  • Hospitalization status [ Time Frame: 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 [ Time Frame: 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 at Day 28
  • Oxygen-free days [ Time Frame: 28 Days ]
    Number of oxygen-free days through Day 28
  • Intensive care unit (ICU) status [ Time Frame: 28 Days ]
    Percentage of subjects transferred to the ICU through Day 28
  • Days on ventilator [ Time Frame: 28 Days ]
    Number of days on mechanical ventilation through Day 28
  • Time to and duration of vasopressor or inotrope utilization [ Time Frame: 28 Days ]
    Time to and duration of vasopressor or inotrope utilization through Day 28
  • Dialysis status [ Time Frame: 28 Days ]
    Percentage of subjects who begin dialysis through Day 28
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2:1 randomization to receive RBT-9:Placebo
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: RBT-9 (90 mg)
    Subjects will receive a single dose and study duration will be approximately 60 days per subject.
  • Drug: 0.9% sodium chloride (normal saline)
    Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Study Arms  ICMJE
  • Experimental: RBT-9 (90 mg)
    RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1.
    Intervention: Drug: RBT-9 (90 mg)
  • Placebo Comparator: Placebo
    0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1.
    Intervention: Drug: 0.9% sodium chloride (normal saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, ≥18 years of age at Screening.
  2. Confirmed infection with SARS-CoV-2.
  3. High risk of COVID-19 disease progression, defined as:

    1. 18-69 years of age with lymphopenia AND 1 additional risk factor (described below)
    2. 18-69 years of age without lymphopenia AND 2 risk factors (described below)
    3. ≥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
  4. 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).
  5. 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.
  6. For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit.
  7. 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.
  8. Must be willing and able to give informed consent and comply with all study procedures.

Exclusion Criteria:

  1. Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours.
  2. 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.
  3. Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening.
  4. Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening.
  5. Requires non-invasive ventilation at the time of Screening.
  6. Requires dialysis at the time of Screening.
  7. 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.
  8. Pregnant or lactating.
  9. History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9.
  10. Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product.
  11. Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug.
  12. Inability to comply with the requirements of the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Austin Keyser, PharmD 682-285-1733 covid19trials@renibus.com
Contact: Stacey Ruiz, PhD sruiz@renibus.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04364763
Other Study ID Numbers  ICMJE REN-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Renibus Therapeutics, Inc.
Study Sponsor  ICMJE Renibus Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Renibus Therapeutics, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP