# Pilot study of RTB101 as COVID-19 prophylaxis in older adults

> **NIH NIH R01** · RESTORBIO, INC. · 2020 · $659,614

## Abstract

Abstract
Given the elevated mortality of COVID-19 infections in older adults (Wu et al 2020), there is an
urgent need to evaluate medicines that may prevent severe disease in these vulnerable
patients. Inhibition of targets downstream of target of rapamycin complex 1 (TORC1) was
reported to upregulate pan-antiviral gene expression and protect mice from a viral respiratory
tract infection (RTI) (York AG et al. 2015). Importantly, RTB101 was also observed to
upregulate interferon-stimulated pan-antiviral gene expression, decrease the levels of
inflammatory cytokines in serum, and decrease the incidence and severity of viral respiratory
tract infections including coronavirus infections when given as prophylaxis during winter cold
and flu season to older adults (Mannick et al. 2018, Mannick et al., 2019). Therefore we
hypothesize that RTB101 will decrease the incidence and severity of COVID-19 when given as
prophylaxis to older adults. Before undertaking a large well-powered trial for this indication, we
propose to undertake a pilot study to determine the feasibility of recruiting, consenting,
screening and randomizing quarantined outpatient populations of older adults who are predicted
to be at increased risk of developing COVID-19 (Specific Aim 1), assess whether COVID-19
symptoms can be tracked using an eDiary in older adults (Specific Aim 2), and obtain
preliminary data on the incidence and severity of COVID-19 in subjects treated with RTB101 as
compared to placebo (Specific Aim 3). The data generated in the trial will be used to help
optimize the study design of a larger adequately powered study to determine if RTB101 is
effective as COVID-19 prophylaxis in the older adults.
References
1. Mannick, J. B., Morris M, Hockey HP, Roma G, Beibel M, Kulmatycki K et al. (2018)
 TORC1 inhibition enhances immune function and reduces infections in the elderly. Sci
 Transl Med 10, doi:10.1126/scitranslmed.aaq1564.
2. Mannick et al, (abstract) IDWeek, 2019.
3. Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus
 Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases
 From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24.
4. York AG, Williams KJ, Argus JP, Zhou QD, Brar G, et al. (2015)
 Limiting Cholesterol Biosynthetic Flux Spontaneously Engages Type I IFN Signaling.
 Cell. 163(7):1716-29.

## Key facts

- **NIH application ID:** 10170919
- **Project number:** 3R01AG064802-02S1
- **Recipient organization:** RESTORBIO, INC.
- **Principal Investigator:** JOAN B MANNICK
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $659,614
- **Award type:** 3
- **Project period:** 2019-05-15 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10170919

## Citation

> US National Institutes of Health, RePORTER application 10170919, Pilot study of RTB101 as COVID-19 prophylaxis in older adults (3R01AG064802-02S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10170919. Licensed CC0.

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