Covid19Phase 2NCT04584710
A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults
A Phase 2 study testing RTB101 in people with Covid19, run by Restorbio Inc. at 2 sites in United States.
Trial summary
The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial. 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2020to Feb 2021
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Any subject who self-reports:
- As a current smoker, or stopped smoking within the past 6 months.
- As a previous smoker with a ≥10 pack year smoking history.
- Has a household member who currently smokes in the house.
- Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
- The subject has already had symptoms consistent with COVID-19 at screening.
Show all 21Show fewer
- Subjects who require chronic supplemental oxygen therapy at screening.
- 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 or hematologic disorder (including active leukemia) for which they have had an exacerbation of symptoms within the past month, or are undergoing a change in treatment.
- The following cardiac conditions:
- Unstable angina pectoris
- History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
- Congestive heart failure requiring active treatment with a prescription medication
- Unstable or life-threatening cardiac arrhythmia
- Chronic stable atrial fibrillation is allowed
- Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.).
- Psoriasis confined to the skin and eczema are allowed
- Subjects receiving immunosuppressive therapy including chronic use of supraphysiologic steroids such as 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 history of a positive human immunodeficiency virus (HIV) test result.
- Subjects with a history of gastric bypass surgery.
- Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
- Use of any other investigational medication or participation in any other investigational study within 5 half-lives of the investigational medication, or within 30 days, whichever is longer; or longer if required by local regulations.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut, UConn Center on Aging
Farmington, Connecticut, 06030
Hebrew Senior Life, Marcus Institute for Aging Research
Roslindale, Massachusetts, 02131
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Adults Age ≥65 Years
The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.
Read the detailed description
The RTB101-211 study is a Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Asymptomatic Adults Age ≥65 Years who: have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19. The study is designed to obtain study feasibility data for RTB101 in an unbiased fashion and will inform the design of a subsequent pivotal trial.
- 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 2 weeks
PlaceboDrug
Also called Placebo capsule
Oral matching placebo once daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 10 mg daily RTB101 | Experimental | RTB101
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.
To determine the length of time from date of receipt of a positive SARS-CoV2 test result to date of first dose of study drug in asymptomatic adults age ≥ 65 years
The number of days from the date of receipt of a positive SARS-CoV-2 swab test result to the date of first dose of study drug in asymptomatic subjects who:
- have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR
- live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19
Measured: Beginning of randomization through Week 2
Secondary outcomes (10)
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on data reported in an eDiary
Measured: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on data from twice weekly phone calls
Measured: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on a pill count done by phone when subjects complete study drug treatment
Measured: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Incidence and severity of COVID-19 symptoms based on data reported in an eDiary
Measured: From time of first dose through Week 3
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Incidence and severity of COVID-19 symptoms based on data from twice weekly phone calls
Measured: From time of first dose through Week 3
To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo
Safety and tolerability will be assessed by report of AE/SAEs from first dose of study drug through Week 3
Measured: From time of first dose through Week 3
To determine the percentage of subjects treated with RTB101 as compared to placebo who develop symptomatic laboratory-confirmed COVID-19 from first dose through Day 14
The percentage of subjects who have SARS-CoV-2 detected on nasal or nasopharyngeal swab and who develop 2 or more concurrent symptoms of COVID-19 from first dose of study drug through Day 14
Measured: From time of first dose through Week 2
To determine the percentage of subjects treated with RTB101 as compared to placebo who die from any cause from first dose of study drug through Day 14 and 21
The percentage of subjects who die from any cause from first dose of study drug through Day 14 and 21
Measured: From time of first dose through Week 3
To determine the percentage of subjects treated with RTB101 as compared to placebo who develop laboratory-confirmed COVID-19 from first dose through Day 14 and are subsequently hospitalized for any reason through Day 21
The percentage of subjects who develop laboratory-confirmed COVID-19 from first dose of study drug through Day 14 and are subsequently hospitalized for any reason through Day 21
Measured: From time of first dose through Week 3
To determine the percent of subjects treated with RTB101 or placebo who have laboratory-confirmed SARS-CoV-2 infection regardless of symptoms from first dose of study drug through Days 7, 14, 21.
The percentage of subjects who have SARS-CoV-2 detected on nasal or nasopharyngeal swab regardless of symptoms from first dose of study drug through Day 7, 14, and 21 among subjects who are not SARS-CoV-2 positive at screening or baseline
Measured: From time of first dose through Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start13 Oct 2020
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorbio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Restorbio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584710
- Sponsor's protocol ID
- RTB101-211
- Other IDs
- 3R01AG064802-02S1
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Adults Age ≥65 Years
- ClinicalTrials.gov ID
- NCT04584710
- Acronym / sponsor ID
- RTB101-211
- Conditions
- Covid19
- Keywords
- Mechanistic Target of Rapamycin (mTOR), Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Restorbio Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 14 Oct 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 proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.
Detailed description
The RTB101-211 study is a Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Asymptomatic Adults Age ≥65 Years who: have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19. The study is designed to obtain study feasibility data for RTB101 in an unbiased fashion and will inform the design of a subsequent pivotal trial.
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: RTB101RTB101 TORC1 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 (0 listed)
Key exclusion criteria (21 listed)
- Any subject who self-reports:
- Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
- The subject has already had symptoms consistent with COVID-19 at screening.
- Subjects who require chronic supplemental oxygen therapy at screening.
- 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 or hematologic disorder (including active leukemia) for which they have had an exacerbation of symptoms within the past month, or are undergoing a change in treatment.
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 2 weeks | Drug | 10 mg daily RTB101 |
| PlaceboAlso: Placebo capsuleOral matching placebo once daily for 2 weeks | Drug | Placebo |
Primary outcome
To determine the length of time from date of receipt of a positive SARS-CoV2 test result to date of first dose of study drug in asymptomatic adults age ≥ 65 years
Time frame: Beginning of randomization through Week 2
The number of days from the date of receipt of a positive SARS-CoV-2 swab test result to the date of first dose of study drug in asymptomatic subjects who: * have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR * live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19
10 secondary outcomes
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Time frame: From time of first dose through Week 3
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Time frame: From time of first dose through Week 3
To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo
Time frame: From time of first dose through Week 3
To determine the percentage of subjects treated with RTB101 as compared to placebo who develop symptomatic laboratory-confirmed COVID-19 from first dose through Day 14
Time frame: From time of first dose through Week 2
To determine the percentage of subjects treated with RTB101 as compared to placebo who die from any cause from first dose of study drug through Day 14 and 21
Time frame: From time of first dose through Week 3
To determine the percentage of subjects treated with RTB101 as compared to placebo who develop laboratory-confirmed COVID-19 from first dose through Day 14 and are subsequently hospitalized for any reason through Day 21
Time frame: From time of first dose through Week 3
To determine the percent of subjects treated with RTB101 or placebo who have laboratory-confirmed SARS-CoV-2 infection regardless of symptoms from first dose of study drug through Days 7, 14, 21.
Time frame: From time of first dose through Week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- 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.
Medical Monitor study director
Restorbio Inc.
2 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 RTB101 in people with Covid19, run by Restorbio Inc. at 2 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 0 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 9 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 2 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the length of time from date of receipt of a positive SARS-CoV2 test result to date of first dose of study drug in asymptomatic adults age ≥ 65 years (time frame: Beginning of randomization through Week 2). 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 9 Feb 2021.