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

NCT04364763 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: REN-005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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

  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

Study Arms (2)

RBT-9 (90 mg)

EXPERIMENTAL

RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1.

Drug: RBT-9 (90 mg)

Placebo

PLACEBO COMPARATOR

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)

Interventions

RBT-9 (90 mg) DRUG

Subjects will receive a single dose and study duration will be approximately 60 days per subject.

RBT-9 (90 mg)

0.9% sodium chloride (normal saline) DRUG

Subjects will receive a single dose and study duration will be approximately 60 days per subject.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• years of age with lymphopenia AND 1 additional risk factor (described below)
• 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

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.

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (5)

New Smyrna Beach, FL

New Smyrna Beach, Florida, 32168, United States

Location

Berkley, MI

Berkley, Michigan, 48072, United States

Location

El Paso, TX

El Paso, Texas, 79935, United States

Location

Fort Worth, TX

Fort Worth, Texas, 76104, United States

Location

Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

tin protoporphyrin IX; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Stacey Ruiz
• Organization: Renibus Therapeutics

sruiz@renibus.com

682-285-1711

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization to receive RBT-9:Placebo

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 28, 2020
• Study Start: August 5, 2020
• Primary Completion: September 2, 2021
• Study Completion: September 30, 2021
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)