COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04536051

Volunteer Recruitment Coordinator

vaccinetrials@ndm.ox.ac.uk

2020-09-02

Unknown

RCT

Randomized

Sequential assignment

Blind label

multi-center

Prevention

inclusion criteria: - adults from 18 to 55 years of age - adults aged 56-69 years old (after review of safety data by dsmb in this age group in the uk trial) - adults aged 70 and above years old (after review of safety data by dsmb in this age group in the uk trial) - able and willing (in the investigator's opinion) to fulfill all study requirements; - health professionals and adults at high risk of exposure to sars-cov-2, as defined in section 5.2 of this protocol; - serology with sars-cov-2 negative igg antibodies; this inclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards. - willing to allow investigators to discuss the participant's clinical history with their gp/personal physician and access medical records relevant to the study procedures - only for women of childbearing age willing to practice continuous effective birth control (see below) during the study, and a negative pregnancy test on the screening and vaccination day(s); - consent to abstain from blood donation during the course of the study; - provide informed consent in writing

- participation in trials of prophylactic drugs for covid-19 during the course of the study; note: participation in covid-19 treatment trials is permitted in case of hospitalization due to covid-19, after confirmation of positive pcr. the study team should be informed as soon as possible. participants with covid-19 not hospitalized with positive pcr results for covid-19 may be medicated according to standard clinical practice. - participation in sars-cov-2 serological research where participants are informed of their serological status during the course of the study; - planned receipt of any vaccine (authorized or investigational), within 30 days before and after vaccination; - prior receipt of an investigational vaccine or authorized with the possibility of impacting the interpretation of the study data (for example, vaccines vectorized by adenovirus, any vaccines against coronavirus); - administration of immunoglobulins and/or any blood products in the three months prior to the planned administration of the candidate vaccine; - any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days); - history of allergic disease or reactions possibly exacerbated by any component of chadox1 ncov-19 or menacwy or paracetamol; - any history of angioedema; - any history of anaphylaxis; - pregnancy, lactation or willingness/intention to become pregnant during the study; - current diagnosis or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); - history of severe psychiatric illness that possibly affects your participation in the study; - hemorrhagic disorder (for example, factor deficiency, coagulopathy or platelet disorder), or a previous history of significant bleeding or bruising after im injections or venipuncture; - current suspected or known dependence on alcohol or drugs; - severe and/or uncontrolled cardiovascular diseases, respiratory diseases, gastrointestinal diseases, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are allowed); - history of covid-19 confirmed by laboratory; - seropositive for antibodies to sars-cov-2 before recruitment; this exclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards - continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban); - any other significant illness, disorder or finding that may significantly increase the risk for the participant, affect his/her ability to participate in the study or impair the interpretation of the study data. re-vaccination exclusion criteria (two-dose groups only) - anaphylactic reaction following administration of vaccine - pregnancy

4

University of Oxford

18

100

Brazil

Health workers

N/A

10300

Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR

None

Phase 3

[{"arm_notes": "5x10^10 vp;1", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5x10^10vp;2;4-12 weeks apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 780, "treatment_name": "Menacwy vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "2", "treatment_id": 780, "treatment_name": "Menacwy vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]