NCT05184062.

Study name	A study to evaluate the safety and tolerability of AZD7442 in Chinese adults
Methods	Drug name: AZD7442 Trial design: randomised, placebo‐controlled, double‐blind, phase 2 study NCT number: NCT05184062 (date of trial registration: 11 January 2022) Target sample size: 272 participants (estimated enrolment) Estimated completion date: 30 June 2023
Participants	Setting Outpatient, PrEP or PEP not further specified Recruitment period: December 2021 to August 2022 China Eligibility criteria Inclusion criteria Adults ≥ 18 years Negative results SARS‐CoV‐2 RT‐qPCR Healthy or medically stable participants Contraceptive within 365 days post dosing Exclusion criteria Medical condition: known hypersensitivity to mAb or investigational product component acute illness including fever on the day prior to or day of dosing any other significant disease increase the risk to participant study Laboratory related: aspartate aminotransferase or alanine aminotransferase > 2.0 × ULN, alkaline phosphatase > 1.5 × ULN, or total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome) serum creatinine > 176 μmol/L haemoglobin < 10 g/dL platelet count < 100 × 103/μL White blood cell count < 3.5 × 103/μL or neutrophil count < 1.5 × 103/μL other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results COVID‐19 infection history/any receipt of mAb indicated for COVID‐19 Prior/concomitant treatment: receipt of any investigational product within 90 days or 5 antibody half‐lives (whichever is longer) prior to day 1
Interventions	AZD7442 Target: RBD region of SARS‐CoV‐2 spike protein Origin: NR Dose: 600 mg Frequency: single dose Route of administration: IV injection Comparator Placebo, single dose, IV injection
Outcomes	Efficacy outcomes Infection with SARS‐CoV‐2 (confirmed by positive RT‐PCR test) within 30 days: not planned Development of COVID‐19 symptoms within 30 days: not planned Mortality at day 28, day 60, longest follow‐up, and time‐to‐event: not planned Admission to hospital within 30 days: not planned Admission to ICU within 30 days: not planned Quality of life assessed with standardised scales (e.g. WHOQOL‐100) at up to 7 days; up to 30 days, and longest follow‐up available: not planned Safety outcomes Number of participants with AEs: planned  Number of participants with SAEs: planned Additional study outcomes Incidence of AESIs Safety as determined by abnormality in haematology Safety as determined by abnormality in clinical chemistry Safety as determined by abnormality in urinalysis Safety as determined by abnormality in coagulation Incidence of abnormal 12‐lead electrocardiogram Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)
Starting date	3 December 2021
Contact information	NR
Notes	Developer: AstraZeneca Funding: AstraZeneca Recruitment status: active, not recruiting

Ab: antibody; ACE: angiotensin‐converting enzyme; AE: adverse event; AESI: adverse event of special interest; BMI: body mass index; COVID‐19: coronavirus disease 2019; FSH: follicle‐stimulating hormone; ICU: intensive care unit; IM: intramuscular(ly); IMP: investigational medical product; IV: intravenous; IVIG: intravenous immunoglobulin; mAb: monoclonal antibody;  MERS: Middle East respiratory syndrome; NCT: National Clinical Trial; NP: nasopharyngeal; NR: not reported; PCR: polymerase chain reaction; PI: principal investigator; RBD: receptor‐binding domain; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; RT‐qPCR: quantitative reverse transcription polymerase chain reaction;  SAE: severe adverse event; SARS: severe acute respiratory syndrome; AE: adverse event,   SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; TIG: tetanus‐specific immunoglobulin; ULN: upper limit of normal; VZIG: varicella zoster immunoglobulin.