Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT05713318
Eligibility Criteria:
Inclusion Criteria:
* Participants who are ≥18 years of age .
* Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
* Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
* Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
Exclusion Criteria:
* Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
* Bronchial asthma or chronic obstructive pulmonary disease （COPD).
* Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
* Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
* History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05713318
Study Brief:
Protocol Section:
NCT05713318