COVID-19
Conditions
Interventions
Amubarvimab/Romlusevimab:iv
placebo:normal saline (iv)
Sponsors
The First Affiliate Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Booster vaccination (third shot) of SARS-CoV-2 more than 8 weekL; 2. Aged >= 60 years with diabetes requiring hypoglycemic medication, or aged >= 18 years with chronic renal insufficiency and receiving dialysis treatment for >= 6 months, or rheumatic immune disease with continuous regular glucocorticoid treatment (equivalent to or higher than prednisone 10mg/ day) for >= 3 months at the time of signing the informed consent form; 3.The participants (including their mates) have no pregnancy plan and voluntarily take effective contraceptive from the time of signing informed consent until 48 weeks after medicine (Amubarvimab and Romlusevimab ) infusion; 4.The participants sign the informed consent form, fully understand the research content, process and possible adverse reactions, and be able to complete the research according to the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: 1. SARS-CoV-2 or SARS-CoV-1 infection history; 2. SARS-CoV-2 RT-PCR was positive during screening; 3. Severe allergy or intolerance to drugs, food and drug ingredients, unless approved by the investigator; 4. Unstable state of underline disease, determined by the researcher, within 1 month before screening; 5. Participate in other clinical trials within 90 days before screening, or within 5 half-lives of the drugs in the previous trials; 6. Any comorbidities that required surgical treatment within 7 days before enrollment or life-threatening comorbidities that occurred within 30 days before enrollment; 7. COVID-19 convalescent plasma or SARS-CoV-2 monoclonal neutralizing antibody treatment at any time before enrollment; 8. Female participants who had a positive pregnancy test, were pregnant or breastfeeding at the time of screening; 9. The investigator determined that participation in the study would not be in the best interest of the subjects or limiting protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing activity of serum; | — |
Countries
China
Contacts
Public ContactNanshan Zhong
The First Affiliate Hospital of Guangzhou Medical University
Outcome results
None listed