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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT04346368
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to provide written informed consent prior to performing study procedures
2. Age ≥18 years, and ≤75 years;
A confirmed case of Covid-19. The criteria are as follows:
Clinically diagnosed or suspected cases with one of the following etiological evidence: 1) SARS-CoV-2 nucleic acid is positive in respiratory or blood samples detected by RT-PCR; 2) virus sequence detected in respiratory or blood samples shares high homology with the known sequence of SARS-CoV-2.
3. Clinical classification is severe case: Meet any of the following:
1\) Increased respiratory rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; 2) Peripheral capillary oxygen saturation (SpO2) ≤93% at rest ; 3)Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa).
Exclusion Criteria:
1. Other types of viral pneumonia, or bacterial pneumonia.
2. The clinical classification is mild, moderate or critical;
3. Patients with malignant blood or solid tumor.
4. Pregnant or lactating women;
5. There are other situations or diseases that the investigator think are not suitable to participate in this clinical study or may be increased risk of the subject.
6. Patients with serious social and mental disability, inability/restriction of legal capacity;
7. Refusal to sign informed consent;
8. Patients with severe liver disease (eg Child Pugh score ≥ C, AST\> 5 times upper limit of normal );
9. Patients with severe renal insufficiency (estimated glomerular filtration rate ≤30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04346368
Study Brief:
Protocol Section:
NCT04346368