COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05184062

Not reported

Not reported

2022-01-11

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: adults ≥ 18 years negative results of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) quantitative reverse transcriptase polymerase chain reaction (qrt-pcr) healthy or medically stable participants contraceptive within 365 days post dosing

medical condition: known hypersensitivity to monoclonal antibody (mab) or investigational product (ip) 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 (ast) or alanine aminotransferase (alt) > 2.0 × upper limit of normal (uln), alkaline phosphatase (alp) > 1.5 × uln, or tbl (total bilirubin) > 1.5 × uln (unless due to gilbert's syndrome). serum creatinine > 176 μmol/l. haemoglobin < 10g/dl. platelet count < 100 × 10^3/μl. white blood cell count < 3.5 × 10^3/μl or neutrophil count < 1.5 × 10^3/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

2

AstraZeneca

18

100

China

Healthy volunteers

N/A

272

Incidence of abnormal 12-lead electrocardiogram (ECG);Incidence of adverse event of special interests (AESIs);Incidence of adverse events (AEs);Incidence of serious adverse events (SAEs);Safety as determined by abnormality in clinical chemistry;Safety as determined by abnormality in Coagulation.;Safety as determined by abnormality in haematology;Safety as determined by abnormality in urinalysis;Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)

None

Phase 2

[{"arm_notes": "600 mg IV", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]