Covid-19 Living Data

Trial NCT04400838 ; ISRCTN
Publication Ramasamy MN, Lancet, 2020
Dates: 30/05/2020 to 08/08/2020
Funding: Mixed (UK Research and Innovation, National Institutes 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.)
Conflict of interest: Yes

Methods
	RCT
	Location : / United Kingdom Follow-up duration (months): 57
	*
Inclusion criteria	Adults aged 18–55 years, 56–69 years, and 70 years and older 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 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 Written informed consent
Exclusion criteria	Participants aged 65 years and older with a Dalhousie Clinical Frailty Score of 4 or higher 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 Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data 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 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 History of serious psychiatric condition likely to affect participation in the study Bleeding disorder Continuous use of anticoagulants 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) History of laboratory confirmed COVID-19
Interventions
	Intervention 2 IM low (2.2 × 10¹? vp) doses on day 0/28 of ChAdOx1 nCoV-19 vaccine 1 IM low (2.2 × 10¹? vp) dose of ChAdOx1 nCoV-19 vaccine 1 IM low (2.2 × 10¹? vp) dose of ChAdOx1 nCoV-19 vaccine 2 IM low (2.2 × 10¹? vp) doses on day 0/28 of ChAdOx1 nCoV-19 vaccine 2 IM standard (3.5-6.5 × 10¹? vp) doses on day 0/28 of ChAdOx1 nCoV-19 vaccine 1 IM standard (3.5-6.5 × 10¹? vp) dose of ChAdOx1 nCoV-19 vaccine 1 IM standard (3.5-6.5 × 10¹? vp) dose of ChAdOx1 nCoV-19 vaccine 2 IM standard (3.5-6.5 × 10¹? vp) doses on day 0/28 of ChAdOx1 nCoV-19 vaccine
	Control 2 IM doses on day 0/28 of MenACWY control vaccine1 IM dose of MenACWY control vaccine1 IM dose of MenACWY control vaccine2 IM doses on day 0/28 of MenACWY control vaccine2 IM doses on day 0/28 of MenACWY control vaccine1 IM dose of MenACWY control vaccine1 IM dose of MenACWY control vaccine2 IM doses on day 0/28 of MenACWY control vaccine
Participants
	Randomized * participants
	Characteristics of participants Type of participants: Healthy volunteers N=* 277 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 22-69
	Description of participants Healthy adults in two centres in the UK
Primary outcome
	In the register Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19 ; Occurrence of serious adverse events (SAEs) throughout the study duration
	In the report The coprimary outcomes of the trial are to assess efficacy as measured by the number of cases of symptomatic, virologically confirmed COVID-19 and safety of the vaccine as measured by the occurrence of serious adverse events
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Data accessibility: NR
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	In addition to the published article, the supplementary appendices, trial registry and study protocol were used in data extraction. Only selected results from the phase 2 component of a continuing phase 2/3 trial are reported in the article, and these do not include the pre-stated primary outcomes in the protocol and registry. Dose concentrations in the published paper are different from those in the trial registry and protocol.