COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04568031

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

2020-09-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - participants aged 18 to 55 years (cohort a and c), aged 56 to 69 years (subcohorts b1 and d1), or aged ≥ 70 years (subcohorts b2 and d2)

known past laboratory-confirmed sars-cov-2 infection positive sars-cov-2 rt pcr test at screening seropositivity to sars-cov-2 at screening. significant infection or other illness, including fever > 37.8°c on the day prior to or day randomization history of guillain-barré syndrome 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 ≤ 14 days) history of allergy to any component of the vaccine any history of angioedema any history of anaphylaxis current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ) history of serious psychiatric condition likely to affect participation in the study bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venepuncture suspected or known current alcohol or drug dependency any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant 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)

2

AstraZeneca

18

100

Japan

Healthy volunteers

N/A

256

Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination;Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters;Number of Participants With Local Solicited Adverse Events (AE);Number of Participants With Systemic Solicited AEs;Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay

None

Phase 1/Phase 2

[{"arm_notes": "1 or 2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]