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Phase 3 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409327
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Restorbio Inc.

Brief 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

Condition or disease Intervention/treatment Phase
COVID19 Drug: RTB101 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Experimental: 10 mg daily RTB101
TORC1 inhibitor
Drug: RTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
Other Names:
  • Dactolisib
  • BEZ235

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Oral matching placebo once daily for 4 weeks
Other Name: Placebo capsule




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection [ Time Frame: Through Week 4 ]
  2. Mortality rate in subjects who develop laboratory-confirmed COVID19 [ Time Frame: Through Week 8 ]
  3. 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 ]
  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 ]
  5. Safety and tolerability will be assessed by report of AE/SAEs [ Time Frame: Through Week 5 and 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409327


Contacts
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Contact: Medical Monitor 857-315-5528 clinicaltrials@restorbio.com

Locations
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United States, Rhode Island
Nursing Home Recruiting
Middletown, Rhode Island, United States, 02842
Sponsors and Collaborators
Restorbio Inc.
Investigators
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Study Director: Medical Director Restorbio Inc.
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Responsible Party: Restorbio Inc.
ClinicalTrials.gov Identifier: NCT04409327    
Other Study ID Numbers: RTB101-210
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Restorbio Inc.:
Mechanistic Target of Rapamycin (mTOR)
Virus
Additional relevant MeSH terms:
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Dactolisib
Antineoplastic Agents