Status:
TERMINATED
A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
Lead Sponsor:
Renibus Therapeutics, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04364763
Start Date
August 5 2020
End Date
September 30 2021
Last Update
March 29 2023
Active Locations (5)
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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