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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 : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Renibus Therapeutics, Inc.

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
COVID-19 Drug: RBT-9 (90 mg) Drug: 0.9% sodium chloride (normal saline) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 randomization to receive RBT-9:Placebo
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. All-cause survival [ Time Frame: 28 Days ]
    Percentage of subjects who are alive at Day 28

  3. 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

  4. Fever incidence [ Time Frame: 28 Days ]
    Percentage of subjects with fever through Day 28

  5. 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

  6. New or worsening congestive heart failure (HF) [ Time Frame: 28 Days ]
    Percentage of subjects with new or worsening congestive HF at Day 28

  7. Hospitalization status [ Time Frame: 28 Days ]
    Percentage of subjects who remain hospitalized at Day 28

  8. 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

  9. Oxygen-free days [ Time Frame: 28 Days ]
    Number of oxygen-free days through Day 28

  10. Intensive care unit (ICU) status [ Time Frame: 28 Days ]
    Percentage of subjects transferred to the ICU through Day 28

  11. Days on ventilator [ Time Frame: 28 Days ]
    Number of days on mechanical ventilation through Day 28

  12. 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

  13. Dialysis status [ Time Frame: 28 Days ]
    Percentage of subjects who begin dialysis through Day 28



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, ≥18 years of age at Screening.
  2. Symptomatic 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 (Stage C or D; or 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% without supplemental oxygen
  4. Admitted to a hospital or are in a controlled facility for observation and standard of care treatment (controlled facility may include emergency room, urgent care facility, long-term acute care facility, temporary/modular hospital, nursing home, 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 ventilator support within 24 hours.
  2. Evidence of acute cardiac injury, as determined by elevated troponin-I at the time of Screening.
  3. Evidence of acute kidney injury at the time of Screening.
  4. Requires supplemental oxygen OR oxygen saturation <90% on room air at the time at the time of Screening.
  5. Requires dialysis at the time of Screening.
  6. Is receiving anti-IL-6 therapies (eg, Tocilizumab, Sarilumab, Siltuximab)
  7. Is receiving Remdesivir.
  8. Known or suspected sepsis at time of Screening.
  9. Pregnant or lactating.
  10. History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9.
  11. Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product.
  12. Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug
  13. Inability to comply with the requirements of the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364763


Contacts
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Contact: Austin Keyser, PharmD 682-285-1733 covid19trials@renibus.com
Contact: Stacey Ruiz, PhD 310-926-6556 sruiz@renibus.com

Sponsors and Collaborators
Renibus Therapeutics, Inc.
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Responsible Party: Renibus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04364763    
Other Study ID Numbers: REN-005
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes