COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN14391248

Rajeka Lazarus

rajeka.lazarus@uhbw.nhs.uk

2021-03-30

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Aged =18 years 2. Received one dose of either: 2.1. ChAdOx1 vaccine, 56 to 90 days prior to trial enrolment 2.2. BNT162b2 vaccine, 28 and 90 days prior to trial enrolment 3. Agree to refrain from blood donation in the 7 days following vaccination (at both visits 1 and 2) 4. Willing to allow their General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the trial 5. Willing to allow investigators to discuss their medical history and confirm vaccination status with their GP, and access all medical records when relevant to trial procedures 6. Willing and able to give written informed consent for participation in the trial 7. Able to use and has access to an electronic device (such as a laptop, tablet, or smartphone) to complete trial procedures (such as the e-diary) 8. Able and willing to comply with all trial requirements, in the Investigator’s opinion

Current exclusion criteria as of 07/05/2021: 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1 2. Administration of immunoglobulins and/or any blood products within three months before visit 1 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients) 4. Bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture and any history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome. Those who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca. 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban) 6. Suspected or known current alcohol or drug dependency 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data 8. Current, active, and progressive neurological disorders (such as multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion 9. Scheduled elective surgery during trial participation if this interferes with the study protocol 10. Participated in another research trial involving an investigational product in the 12 weeks prior to visit 1, or if receipt of any IMP is planned during the trial period 11. Acute, ongoing respiratory illness (moderate or severe illness, with or without fever) at visit 1 12. Fever (oral temperature >37.8°C) at visit 1 Previous exclusion criteria: 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1 2. Administration of immunoglobulins and/or any blood products within three months before visit 1 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients) 4. Bleeding disorder (for example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban) 6. Suspected or known current alcohol or drug dependency 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data

3

University Hospitals Bristol NHS Foundation Trust

18

100

United Kingdom

Healthy volunteers

N/A

756

1. Incidence of =1 solicited systemic reaction measured using an electronic diary completed by participants in the 7 days following visit 1. Solicited systemic adverse events include fever; feverishness; chills; joint pains; muscle pains; fatigue; headache; malaise; nausea; vomiting; and diarrhoea.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "Previously received one COVID-19 vaccine dose 56 to 90 days prior enrolment;1+1", "treatment_id": 1446, "treatment_name": "Chadox1 ncov-19+flu vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Previously received one COVID-19 vaccine dose 56 to 90 days prior enrolment;1+1", "treatment_id": 1430, "treatment_name": "Bnt162b2+flu vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]