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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT05675761
Eligibility Criteria:
Inclusion Criteria:
1. Over 18 years old;
2. Respiratory tract samples (nasopharynx, oropharynx, lower respiratory tract \[such as sputum\]) collected within 96 hours before enrollment were confirmed to be SARS CoV-2 positive by RT-PCR virus molecular amplification;
3. At least one symptom or sign of COVID-19 (symptoms and signs related to COVID-19, including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, nasal congestion, runny nose, etc.);
4. Participants who meet one or more of the following requirements: from the first COVID-19 symptom to the first medication ≤ 5 days;
5. Agree to observe contraceptive measures during the clinical trial;
6. Participants who understand and agree to follow the planned research procedures;
7. Provide follow-up information during the study;
8. Understand the study and be willing to sign the informed consent form.
Exclusion Criteria:
1. Those who are known to be allergic to any component of the intervention preparation used in the test;
2. Patients with abnormal liver function test (alanine aminotransferase and /or glutamic oxaloacetic aminotransferase exceed the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value by 2 times);
3. Patients with a known history of liver disease (cirrhosis with ChildPugh grade B and C);
4. Congestive heart failure within 6 months (NYHA ¾ Grade), patients with untreated symptomatic arrhythmia or myocardial infarction history;
5. Individuals with malabsorption syndrome or other diseases affecting gastrointestinal absorption, and patients who need intravenous nutrition or cannot take orally or through nasogastric tube;
6. Participants who have received other SARS CoV-2 monoclonal antibody therapy or antiviral therapy (including research therapy);
7. Participants who received COVID-19 convalescent plasma therapy;
8. Patients receiving anti HIV treatment;
9. Participants who also participate in any other type of medical research or are considered to be scientifically or medically incompatible with this research;
10. Participants who have participated in the intervention clinical research in the past 30 days should pass 5 half lives or 30 days, whichever is longer, if the previous research intervention has a longer half life.
11. Researchers believe that the test will endanger any health and safety of participants;
12. Women who are pregnant, nursing or planning to be pregnant during the study period or men whose partners plan to be pregnant during the study period;
13. Unable to provide informed consent.Contacts and Locations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05675761
Study Brief:
Protocol Section:
NCT05675761