COVID19Phase 2NCT04409327
Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
A Phase 2 study testing RTB101 in people with COVID19, run by Restorbio Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- RTB101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2020to 24 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Informed consent must be obtained from the subject or health care proxy before any assessment is performed.
- Adults (male and female) aged 65 years and over.
- Residing in a nursing home in which one or more residents or staff has developed laboratory-confirmed symptomatic COVID-19 infection at the time of randomization
Who cannot join
- Subjects will not be eligible if they meet any of the following criteria:
- Any subject who is a current smoker or has a ≥ 10 pack year smoking history.
- Subjects with a medical history of chronic obstructive pulmonary disease (COPD).
- Subjects who are in hospice or receiving comfort care only.
- Subjects who have symptomatic laboratory-confirmed COVID-19 at the time of screening or randomization.
- Subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C hepatic impairment), renal disorder (including subjects with an estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2), or hematologic disorder (including active leukemia).
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- Subjects receiving immunosuppressive therapy including chronic use of prednisone >10 mg daily (however, inhaled corticosteroids and acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions are allowed).
- Subjects with an immunodeficiency disease, including a positive human immunodeficiency virus (HIV) test result.
- Sexually active males with a partner of child-bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19
Read the detailed description
RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may prevent or ameliorate viral RTIs, including COVID-19, in older adults.
- Conditions
- COVID19
- Being tested
- RTB101, Placebo
- Keywords
- Mechanistic Target of Rapamycin (mTOR), Virus
- Medical subject headings
- COVID-19, Hereditary Sensory and Autonomic Neuropathies, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTB101Drug
Also called Dactolisib, BEZ235
Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
PlaceboDrug
Also called Placebo capsule
Oral matching placebo once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 10 mg daily RTB101 | Experimental | TORC1 inhibitor Receives: Drug: RTB101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
Measured: Through Week 4
Secondary outcomes (5)
The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection
Measured: Through Week 4
Mortality rate in subjects who develop laboratory-confirmed COVID19
Measured: Through Week 8
Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2
Measured: Through Week 4
Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19
Measured: Through Week 8
Safety and tolerability will be assessed by report of AE/SAEs
Measured: Through Week 5 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start11 Jul 2020
- Primary completion27 Dec 2020
- Study completion24 Jan 2021
Why it stopped: Insufficient accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restorbio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Restorbio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409327
- Sponsor's protocol ID
- RTB101-210
- Status last verified
- Feb 2021
- First submitted
- 28 May 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19
- ClinicalTrials.gov ID
- NCT04409327
- Acronym / sponsor ID
- RTB101-210
- Conditions
- COVID19
- Keywords
- Mechanistic Target of Rapamycin (mTOR), Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual rate
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Restorbio Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 24 Jan 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19
Detailed description
RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may prevent or ameliorate viral RTIs, including COVID-19, in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg daily RTB101 | Experimental | Drug: RTB101TORC1 inhibitor |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Informed consent must be obtained from the subject or health care proxy before any assessment is performed.
- Adults (male and female) aged 65 years and over.
- Residing in a nursing home in which one or more residents or staff has developed laboratory-confirmed symptomatic COVID-19 infection at the time of randomization
Key exclusion criteria (9 listed)
- Any subject who is a current smoker or has a ≥ 10 pack year smoking history.
- Subjects with a medical history of chronic obstructive pulmonary disease (COPD).
- Subjects who are in hospice or receiving comfort care only.
- Subjects who have symptomatic laboratory-confirmed COVID-19 at the time of screening or randomization.
- Subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C hepatic impairment), renal disorder (including subjects with an estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2), or hematologic disorder (including active leukemia).
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 |
|---|---|---|
| RTB101Also: Dactolisib, BEZ235Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks | Drug | 10 mg daily RTB101 |
| PlaceboAlso: Placebo capsuleOral matching placebo once daily for 4 weeks | Drug | Placebo |
Primary outcome
The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
Time frame: Through Week 4
5 secondary outcomes
The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection
Time frame: Through Week 4
Mortality rate in subjects who develop laboratory-confirmed COVID19
Time frame: Through Week 8
Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2
Time frame: Through Week 4
Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19
Time frame: Through Week 8
Safety and tolerability will be assessed by report of AE/SAEs
Time frame: Through Week 5 and 8
Results and safety
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Medical Director study director
Restorbio Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTB101 in people with COVID19, run by Restorbio Inc. at 1 site 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 3 inclusion and 9 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
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?
The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die (time frame: Through Week 4). 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 10 Feb 2021.