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Trial - ACTRN12621001412820


Column Value
Trial registration number ACTRN12621001412820
Full text link
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Prof P Toby H Coates

Contact
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Toby.Coates@sa.gov.au

Registration date
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2021-10-20

Recruitment status
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

- Kidney transplant recipients - Aged 18-70 years - estimated GFR >25 mL/min - Spot urinary albumin:creatinine ratio <100 mg/µmol - Current immunosuppression regimen comprising tacrolimus, mycophenolate, prednisolone - Treating nephrologist agrees that patient is suitable for sirolimus maintenance immunosuppression - Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have demonstrably not responded (anti-Receptor Binding Domain antibody titre < 100 U/mL)

Exclusion criteria
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

- Multi-organ transplant recipients (e.g. kidney-pancreas) - Aged <18 years or >70 years - Significant kidney dysfunction, estimated GFR =25 mL/min or spot urinary albumin:creatinine ratio =100 mg/µmol - Unable or unwilling to provide informed consent to participate in the trial - Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have mounted an adequate immune response (anti-Receptor Binding Domain antibodies >100 U/mL) - Have had documented infection with COVID-19 - Known allergy to or intolerance of sirolimus or everolimus - Patients who are currently pregnant

Number of arms
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Professor P. Toby H Coates (MBBS FRACP PhD)

Inclusion age min
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Australia

Type of patients
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

High risk patients

Severity scale
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

120

primary outcome
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

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. Patients in the intervention group will also continue fortnightly immunosuppression level checks with phone call follow up for 6 weeks post-vaccination. ]

Notes
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 2022, "treatment_name": "Bnt162b2+sirolimus", "treatment_type": "Rna based vaccine+immunosuppressants", "pharmacological_treatment": "Vaccine+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"}]