Rapamycin and Infection-related Illness

NCT07054320 | Active Not Recruiting DMC

• 1 other identifier: BRANY IRB File # 25-02-270-149
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Conduct a 6-month observational pilot clinical trial to evaluate the safety, monitor the adverse reactions and observe the preliminary effectiveness of medical treatment with oral rapamycin \[Rapamune (Sirolimus)\] in a total of 15 adults, 18 years and older toward preventing and lowering the severity of infectious disease or infection-related illness. Rapamune (Sirolimus) is not approved by the United States Food and Drug Administration (FDA) to prevent and lessen the severity of infection-related illness or infectious disease. Rapamune (Sirolimus) is approved by the FDA for other indications. The main procedures in the study include:

• Blood tests to examine cholesterol, lipids, blood platelet counts, inflammation and infection-related health parameters
• Questionnaires to examine brain function, mental health, symptoms, overall health status and quality of life
• Electrocardiogram (ECG to measure heart function)
• Resting diastolic and systolic blood pressure

Conditions

Infectious Diseases

Keywords

Infectious Disease; Infection-related illness; Rapamycin; Rapamune; Sirolimus

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of infectious disease or infection-related illness

  The Primary Endpoint is the incidence and severity of infectious disease or infection-related illness prior to and 3 and 6 months following the initiation of the observational study measured by: * CBC * WBC * Neutrophils * Lymphocytes * Eosinophils * Basophils * Monocytes * CRP * PCT * ESR * ANC * Incidence of infection-related hospitalizations

  Prior to and 3 and 6 months following the initiation of the observational study

Secondary Outcomes (3)

• Quality of Life (RAND SF-36 Health Survey)

  Prior to and 3 and 6 months following the initiation of the observational study

• Global Health Questionnaire (PROMIS-GHF V1.2)

  Prior to and 3 and 6 months following the initiation of the observational study

• Patient self-report questionnaire

  One year prior and 3 and 6 months following the initiation of the observational study

Interventions

Observational procedures OTHER

Patients at the Hoskinson Health and Wellness Clinic qualifying for treatment with Rapamune (Sirolimus) receive a prescription from their physician during clinic visits as part of their standard health care. This study will evaluate the safety, monitor the adverse reactions and observe the preliminary effectiveness of physician-prescribed medical treatment with oral rapamycin \[Rapamune (Sirolimus)\] in a total of 15 adults, 18 years and older toward preventing and lowering the severity of infectious disease or infection-related illness.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female adults, 18 years and older

You may qualify if:

• Male or Female Adults, 18 years and older
• Females of child-bearing age taking birth control medication
• Received a Hoskinson Health and Wellness Clinic physician prescription for Rapamune (Sirolimus)

You may not qualify if:

• Adults requiring monoclonal antibody or biological treatment
• Adults diagnosed with an acute lower respiratory or GI infection within 2 weeks
• Adults females who are not taking birth control medication, are pregnant or nursing mothers
• Adults reporting severe mental or physical disability
• Adults reporting unwillingness to travel to onsite clinical facilities
• Adults with any change in chronic disease symptoms or medication within 3 months
• Any contraindications to medical treatment with Rapamune (Sirolimus), as outlined in the FDA-approved medication guide

Sponsors & Collaborators

• Hoskinson Health and Wellness Clinic: lead

Study Sites (1)

Hoskinson Health and Wellness Clinic

Gillette, Wyoming, 82718, United States

Location

Related Publications (6)

• Hays RD, Spritzer KL, Fries JF, Krishnan E. Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis. Ann Rheum Dis. 2015 Jan;74(1):104-7. doi: 10.1136/annrheumdis-2013-204053. Epub 2013 Oct 4.

  PMID: 24095937 BACKGROUND

• Rothrock NE, Amtmann D, Cook KF. Development and validation of an interpretive guide for PROMIS scores. J Patient Rep Outcomes. 2020 Feb 28;4(1):16. doi: 10.1186/s41687-020-0181-7.

  PMID: 32112189 BACKGROUND

• Wu Q, Chen Y, Zhou Y, Zhang X, Huang Y, Liu R. Reliability, validity, and sensitivity of short-form 36 health survey (SF-36) in patients with sick sinus syndrome. Medicine (Baltimore). 2023 Jun 16;102(24):e33979. doi: 10.1097/MD.0000000000033979.

  PMID: 37327281 BACKGROUND

• Gandek B, Sinclair SJ, Kosinski M, Ware JE Jr. Psychometric evaluation of the SF-36 health survey in Medicare managed care. Health Care Financ Rev. 2004 Summer;25(4):5-25.

  PMID: 15493441 BACKGROUND

• Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.

  PMID: 1285753 BACKGROUND

• Kaeberlein TL, Green AS, Haddad G, Hudson J, Isman A, Nyquist A, Rosen BS, Suh Y, Zalzala S, Zhang X, Blagosklonny MV, An JY, Kaeberlein M. Evaluation of off-label rapamycin use to promote healthspan in 333 adults. Geroscience. 2023 Oct;45(5):2757-2768. doi: 10.1007/s11357-023-00818-1. Epub 2023 May 16.

  PMID: 37191826 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Hoskinson, DO

  Hoskinson Health and Wellness Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 6, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)