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Target of Rapamycin Complex 1 (TORC1) inhibitor

10 mg daily RTB101 for Coronavirus

Phase 2
Waitlist Available
Research Sponsored by Restorbio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose through week 3
Awards & highlights

Study 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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose through week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose through week 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
+4 more

Side effects data

From 2019 Phase 3 trial • 1024 Patients • NCT04668352
13%
Therapeutic response unexpected
7%
Diarrhoea
7%
Headache
4%
Asthma
4%
Contusion
4%
Hypertension
4%
Skin abrasion
4%
Arthralgia
4%
Fall
3%
Rash
3%
Muscle strain
3%
Urinary tract infection
3%
Acute myocardial infarction
3%
Pain in extremity
3%
Dizziness
2%
Basal cell carcinoma
2%
Gastroenteritis
2%
Actinic keratosis
2%
Ligament sprain
2%
Muscle spasms
2%
Epistaxis
2%
Asthenia
2%
Fatigue
2%
Skin laceration
2%
Mouth ulceration
2%
Back pain
2%
Lethargy
1%
Myalgia
1%
Dyspnoea
1%
Blood pressure increased
1%
Depression
1%
Eczema
1%
Blister
1%
Osteoarthritis
1%
Renal impairment
1%
Rash erythematous
1%
Gastrooesophageal reflux disease
1%
Dry mouth
1%
Nausea
1%
Flatulence
1%
Atrial flutter
1%
Palpitations
1%
Aphthous ulcer
1%
Splenic embolism
1%
Constipation
1%
Furuncle
1%
Dental caries
1%
Conjunctivitis
1%
Fungal skin infection
1%
Decreased appetite
1%
Oral herpes
1%
Pruritus
1%
Otitis externa
1%
Sneezing
1%
Bursitis
1%
Paraesthesia
1%
Procedural pain
1%
Blood potassium increased
1%
Skin infection
1%
Arthropod bite
1%
Glomerular filtration rate decreased
1%
Skin ulcer
1%
Vertigo positional
1%
Toothache
1%
Chest pain
1%
Diverticulitis
1%
Localised infection
1%
Blood alkaline phosphatase increased
1%
Haemoglobin decreased
1%
Type 2 diabetes mellitus
1%
Sinusitis
1%
Iron deficiency anaemia
1%
Lip ulceration
1%
Oedema peripheral
1%
Pain
1%
Bronchitis
1%
Tooth infection
1%
Hypercholesterolaemia
1%
Plantar fasciitis
1%
Tendonitis
1%
Presyncope
1%
Anaemia
1%
Anxiety
1%
Insomnia
1%
Ear pain
1%
Dyspepsia
1%
Haematoma
1%
Hot flush
1%
Electrocardiogram QT prolonged
1%
Musculoskeletal pain
1%
Neck pain
1%
Oropharyngeal pain
1%
Skin lesion
1%
Vomiting
1%
Chills
1%
Stomatitis
1%
Seborrhoeic keratosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dactolisib 10mg Once Daily

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10 mg daily RTB101Experimental Treatment1 Intervention
RTB101 TORC1 inhibitor
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,666 Previous Clinical Trials
28,005,069 Total Patients Enrolled
Restorbio Inc.Lead Sponsor
4 Previous Clinical Trials
1,712 Total Patients Enrolled
Medical MonitorStudy DirectorRestorbio Inc.
1,649 Previous Clinical Trials
979,665 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults
2020. "A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584710.
~13 spots leftby Apr 2025
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