Trial Outcomes & Findings for A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) (NCT NCT04364763)

Last Updated: 2023-03-29

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

baseline and 7 days, baseline and 28 days

Results posted on

2023-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	RBT-9 (90 mg) RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Overall Study STARTED	28	14
Overall Study COMPLETED	26	12
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RBT-9 (90 mg) RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Overall Study Death	1	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RBT-9 (90 mg) n=28 Participants RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo n=14 Participants 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	53.6 Years STANDARD_DEVIATION 16.59 • n=5 Participants	57.6 Years STANDARD_DEVIATION 17.11 • n=7 Participants	55 Years STANDARD_DEVIATION 16.66 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	14 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 7 days, baseline and 28 days

Outcome measures

Outcome measures
Measure	RBT-9 (90 mg) n=28 Participants RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo n=14 Participants 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.
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 Day 7	-1.0 units on a scale Interval -1.6 to -0.5	-0.0 units on a scale Interval -0.8 to 0.8
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 Day 28	-1.2 units on a scale Interval -1.8 to -0.7	-0.6 units on a scale Interval -1.5 to 0.4

Adverse Events

RBT-9 (90 mg)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	RBT-9 (90 mg) n=28 participants at risk RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo n=14 participants at risk 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Cardiac disorders Myocardial Infarction	0.00% 0/28 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Nervous system disorders Cerebral Infarct	3.6% 1/28 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	0.00% 0/14 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.6% 1/28 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	0.00% 0/14 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Respiratory, thoracic and mediastinal disorders Lung mass	3.6% 1/28 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	0.00% 0/14 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.

Other adverse events

Other adverse events
Measure	RBT-9 (90 mg) n=28 participants at risk RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1. RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.	Placebo n=14 participants at risk 0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1. 0.9% sodium chloride (normal saline): Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Skin and subcutaneous tissue disorders Erythema	7.1% 2/28 • Number of events 2 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	0.00% 0/14 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Skin and subcutaneous tissue disorders Rash	3.6% 1/28 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Psychiatric disorders Insomnia	3.6% 1/28 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Infections and infestations Onychomycosis	0.00% 0/28 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Infections and infestations Tinea cruris	0.00% 0/28 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Nervous system disorders Paresthesia	100.0% 2/2 • Number of events 2 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	0.00% 0/14 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.
Cardiac disorders Tachycardia	0.00% 0/28 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.	7.1% 1/14 • Number of events 1 • Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject. AEs and SAEs determined to be related to COVID-19 were not reportable under the requirements of this protocol. Rather, they were reported as complications or signs/symptoms of COVID.

Additional Information

Stacey Ruiz

Renibus Therapeutics

Phone: 682-285-1711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60