COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT02081326

Denise L Faustman, MD, PhD

Not reported

20/07/2021

Not recruiting

RCT

Randomized

Adaptive

Blind label

single-center

Prevention

inclusion criteria: - type 1 diabetes treated continuously with insulin from time of diagnosis - age 18-65 - hiv antibody negative - normal cbc - hcg negative (females) - anti-gad positive (except for subjects with c-peptide <10pmol/l) - fasting or stimulated c-peptide between 5-200 pmol/l - participation in protocol #2001p001379, "autoimmunity: in vitro pathogenesis and early detection"

- history of chronic infectious disease such as hiv or hepatitis - history of tuberculosis, tb risk factors, positive interferon-gamma release assay (igra, also known as the t-spot.tb test), or bcg vaccination - current treatment with glucocorticoids (other than intermittent nasal or eye steroids), or disease or condition likely to require steroid therapy - other conditions or treatments associated with increased risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason - current treatment with aspirin > 160 mg/day or chronic, daily nsaids - current treatment with antibiotics - history of keloid formation - average hba1c over the past 5 years (or since diagnosis if duration is less than 5 years) <6.5 or > 8.5% - history or evidence of chronic kidney disease (serum creatinine > 1.5mg/dl) - history of proliferative diabetic retinopathy that has not been treated with laser therapy - history of neuropathy, foot ulcers, amputations, or kidney disease - pregnant or not using acceptable birth control - living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example hiv+ or taking immunosuppressive medications for any reason)

2

Massachusetts General Hospital

18

65

United States

High risk patients

N/A

150

Change in HbA1c values in juvenile onset type 1 diabetics

None

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]