COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621001465842.aspx

Prof P Toby H Coates

Toby.Coates@sa.gov.au

2021-10-26

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Kidney transplant recipients Aged 18-80 years Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have demonstrably not responded (undetectable anti-spike protein antibodies) or low response (anti-RBD antibody titre < 100 U/mL)

Aged <18 years or >80 years Multi-organ transplant recipients (e.g. kidney-pancreas) Patients who are currently pregnant Patient has an underlying condition predisposing to increased gut permeability (including, but not limited to: active or recent within 6 weeks gastrointestinal infection, inflammatory bowel disease, short-gut syndrome, or coeliac disease) Have not received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have mounted an adequate immune response (anti-spike protein antibodies above detection threshold)

2

Professor P. Toby H Coates (MBBS FRACP PhD)

18

80

Australia

High risk patients

N/A

120

Absolute proportion of patients in each arm meeting the threshold of 20.2% neutralising antibody required for clinical protection from SARS-CoV2 infection. Neutralising antibody titres will be assessed by dilution at which paCoV-2 live virus entry into angiotensin converting enzyme (ACE) 2 receptor positive cells by 50%.[4-6 weeks post-vaccination. During the intervening post-vaccination period patients will be clinically assessed once by phone 1 week post vaccination. ]

Not reported

[{"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 2024, "treatment_name": "Bnt162b2+inulin", "treatment_type": "Rna based vaccine+nutrition", "pharmacological_treatment": "Vaccine+non pharmacological treatment"}, {"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]