COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05142319

Barnaby Young, Dr

Barnaby_Young@ncid.sg

2021-12-02

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: willing and able to provide informed consent for participation in this study; aged ≥21years at the time of study enrolment; received the second dose of bnt162b2 or mrna-1273 coronavirus disease 2019 vaccines at least 6 months prior to enrolment; willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.

known history of sars-cov-2 or sars-cov-1 infection; previously received an investigational coronavirus vaccine; previously received a sars-cov-2 monoclonal antibody; current or planned simultaneous participation in another interventional study; a history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a covid-19 vaccine, or otherwise have a contraindication to one of the available study vaccines per the approved label; individuals who are immunocompromised (e.g. active leukaemia or lymphoma, generalised malignancy, aplastic anaemia, solid organ transplant, bone marrow transplant, current radiation therapy congenital immunodeficiency, hiv/aids with cd4 lymphocyte count < 200 and patients on immunosuppressant medications); received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids >/= 20 milligram per day of prednisone equivalent). topical tacrolimus is allowed if not used within 14 days prior to day 1; individuals who are pregnant or breast feeding; chronic illness that, in the opinion of the study team, is at a stage where it might interfere with trial conduct or completion; deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised involuntarily; current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the study team; moderate or severe acute illness/infection (according to study team's judgement) on the day of vaccination, or febrile illness (temperature ≥ 37.5°c). a prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.

7

Tan Tock Seng Hospital

21

100

Singapore

Healthy volunteers

N/A

600

SARS-CoV-2 anti-spike immunoglobulins

None

Phase 3

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