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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04264858
Eligibility Criteria:
Inclusion Criteria:
1. Volunteers who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe 2019-nCoV pneumonia:
1. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
2. Lung involvement confirmed with pulmonary CT scan.
3. At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.
Exclusion Criteria:
1. Viral pneumonia with other viruses besides 2019-nCoV.
2. Patients are not suitable for immunoglobulin therapy.
3. Participation in other studies.
4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04264858
Study Brief:
Protocol Section:
NCT04264858