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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04364763

Run by

Renibus Therapeutics, Inc.

People needed

42

Starts

2020-08-05

Expected to finish

2021-09-30

Last updated by the study team

2023-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New Smyrna Beach, FL — New Smyrna Beach, Florida, United States
• Berkley, MI — Berkley, Michigan, United States
• El Paso, TX — El Paso, Texas, United States
• Fort Worth, TX — Fort Worth, Texas, United States
• Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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