COVID-19Phase 2NCT04364763
A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
A Phase 2 study testing RBT-9 (90 mg) and 0.9% sodium chloride (normal saline) in people with COVID-19, run by Renibus Therapeutics, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- RBT-9 (90 mg) and 0.9% sodium chloride (normal saline)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2020to 30 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Berkley, MI
Berkley, Michigan, 48072
El Paso, TX
El Paso, Texas, 79935
Fort Worth, TX
Fort Worth, Texas, 76104
Houston
Houston, Texas, 77030
New Smyrna Beach, FL
New Smyrna Beach, Florida, 32168
About this study
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)
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
- Being tested
- RBT-9 (90 mg), 0.9% sodium chloride (normal saline)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBT-9 (90 mg)Drug
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
0.9% sodium chloride (normal saline)Drug
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
| Study group | Role | What they receive |
|---|---|---|
| RBT-9 (90 mg) | Experimental | RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. Receives: 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. Receives: Drug: 0.9% sodium chloride (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 7 days, baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start5 Aug 2020
- Primary completion2 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Enrollment feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization to receive RBT-9:Placebo
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364763
- Sponsor's protocol ID
- REN-005
- Status last verified
- Mar 2023
- First submitted
- 20 Apr 2020
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04364763
- Acronym / sponsor ID
- REN-005
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment feasibility
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Renibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization to receive RBT-9:Placebo
| Arm | Type | Receives |
|---|---|---|
| RBT-9 (90 mg) | Experimental | Drug: RBT-9 (90 mg)RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. |
| Placebo | Placebo comparator | Drug: 0.9% sodium chloride (normal saline)0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female, ≥18 years of age at Screening.
- Confirmed infection with SARS-CoV-2.
- High risk of COVID-19 disease progression, defined as:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBT-9 (90 mg)Subjects will receive a single dose and study duration will be approximately 60 days per subject. | Drug | RBT-9 (90 mg) |
| 0.9% sodium chloride (normal saline)Subjects will receive a single dose and study duration will be approximately 60 days per subject. | Drug | Placebo |
Primary outcome
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: baseline and 7 days, baseline and 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBT-9 (90 mg) and 0.9% sodium chloride (normal saline) in people with COVID-19, run by Renibus Therapeutics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: baseline and 7 days, baseline and 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.