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:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05679492
Eligibility Criteria:
Inclusion Criteria:
1. Age range from 18 to 80 (including 18 and 80 years old), male or female
2. The subject tested positive for SARS-CoV-2 by nucleic acid test within 96 hours (4 days) prior to initial administration
3. The patient is confirmed to be infected with the COVID-19, meeting the diagnostic criteria for mild or moderate patients in the latest version of the COVID-19 Pneumonia Diagnosis and Treatment Protocol (Trial 10th Edition) issued by the Chinese Health Commission, and has at least one symptom of SARS-CoV-2, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting and taste disturbance within 96 hours before the first administration of the drug
4. According to the 12 common symptom assessment forms of SARS-CoV-2 infection, the total symptom assessment score of the subjects before randomization was ≥ 2 points
5. There is at least one possible risk factor for severe/critical SARS-CoV-2: ① Age \> 60 years old; (2) Patients with cardiovascular and cerebrovascular diseases (including hypertension), diabetes, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma), chronic liver and kidney diseases, tumors and other underlying diseases, and the disease should be in a stable period; (3) Immune dysfunction (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs to cause immune dysfunction); ④ Obesity (body mass index ≥30); ⑤ Heavy smokers; ⑥ Those who have not received SARS-CoV-2 vaccine
6. Agree to take highly effective contraceptive measures within 3 months after taking the experimental drug
7. The subject can communicate well with the researcher, understand and comply with the requirements of the study, and understand and sign the informed consent
Exclusion Criteria:
* (1) Severe patients with SARS-CoV-2 meet any of the following criteria
1. Shortness of breath, breathing rate ≥ 30 times /min
2. At rest, oxygen saturation (SpO2) ≤ 93% during air intake
3. Progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 \~ 48 hours \>50%
(2) Critically ill patients with SARS-CoV-2 meet any of the following criteria
1. Respiratory failure occurs and requires mechanical ventilation
2. Shock occurs
3. Combined with other organ failure requires ICU care (3) Allergic constitution, known allergic to the test drug and its components (4) Suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than COVID-19) that researchers believe may pose a risk when implementing interventions (5) Patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) The investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) Any of the following drugs or treatments were used before screening:
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1. Antiviral therapy (e.g., Paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. COVID-19 human immunoglobulin or convalescent plasma), glucocorticoids, IL-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics
2. Those who plan to receive vaccines (including but not limited to COVID-19 vaccine) within 28 days prior to screening or during the study period
3. He is on dialysis (8) When screening, any of the laboratory test indicators meet the following standards
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1. ALT or AST \>3ULN
2. Total bilirubin ≥2 ULN
3. White blood cell count \> ULN
4. Neutrophil absolute value \< 0.5×109/L
5. Platelet count \< 100×109/L
6. eGFR \<60mL /min/ 1.73m2 (calculated by CKD-EPI formula) (9) Weight ≤40 kg (10) Dizzy needle dizzy blood (11) Participated in other drug clinical trials within 3 months prior to screening (12) Pregnant or lactating women or pregnancy-positive women (13) Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and human immunodeficiency virus (HIV) antibody were positive for any one of the results (14) Patients inappropriate for participation for any other reasons at the investigator's discretion.
Note:The investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening.If the conditions of a subject are changed (including laboratory test results)and meet any exclusion criterion at any time from the screening to the first administration,the subject shall beexcluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05679492
Study Brief:
Protocol Section:
NCT05679492