Covid-19 Living Data

Trial ISRCTN89951424 (COV0
Publication Voysey M, Lancet, 2020
Dates: 28/05/2020 to 04/11/2020
Funding: Mixed (United Kingdom National Institute for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca; University of Oxford, Fundação Lemann, Fundação Brava, Fundação Telles, Instituto D’or de Ensino e Pesquisa and AstraZeneca Brasil)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Brazil, United Kingdom Follow-up duration (months): ≈90
	*
Inclusion criteria	Adults aged ≥18 years Able and willing (in the Investigator’s opinion) to comply with all study requirements Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures For females of childbearing potential only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination Agreement to refrain from blood donation during the course of the study Provide written informed consent Health professionals and/or adults at high risk of exposure to SARS-CoV-2
Exclusion criteria	Participation in COVID-19 prophylactic drug trials for the duration of the study Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccination. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines) Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting more than 14 days) History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY Any history of angioedema Any history of anaphylaxis Pregnancy, lactation or willingness/intention to become pregnant during the study Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) History of serious psychiatric condition likely to affect participation in the study Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Suspected or known current alcohol or drug dependency Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
Interventions
	Intervention 2 IM doses (2.2-6.5 x 10¹? vp) ChAdOx1 nCoV-19 vaccine on Days 0/28
	Control 1 IM dose of MenACWY control vaccine on Day 0, 1 IM dose of MenACWY control vaccine or normal salin
Participants
	Randomized * participants
	Characteristics of participants Type of participants: Healthy volunteers N=* 4591 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: ≥18
	Description of participants Healthy adults from two studies in multiple centres in Brazil and the UK
Primary outcome
	In the register Virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19; Occurrence of serious adverse events (SAEs) throughout the study duration
	In the report Virologically confirmed, symptomatic COVID-19, defined as a NAAT-positive swab combined with at least one qualifying symptom (fever ?37·8°C, cough, shortness of breath, or anosmia or ageusia)
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, when the trials are complete Data accessibility: data can be shared through a secure online platform after signing a data access agreement
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	*
General comment	*