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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT05855395
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 65;
* Male or female;
* Positive test for coronavirus antigen or nucleic acid；
* Within 7 days of onset (fever and/or cough) ；
* mild and moderate；Mild: respiratory tract infection is the main manifestation, such as dry throat, sore throat, cough, fever；Moderate: continuous high fever\>3 days or (and) cough, shortness of breath, etc., but respiratory rate (RR)\<30 times/minute, oxygen saturation\>93% when breathing air at rest. Imaging findings of characteristic pneumonia caused by COVID-19 infection；
* The patient is willing to participate in the trial treatment and follow-up, and sign the informed consent form (if the patient lacks the ability to give informed consent due to his serious medical condition, such as acute respiratory failure or the need for respiratory support, he can obtain the consent of the patient's legal representative)；
* No systemic glucocorticoids treatment in the past 7 days；
Exclusion Criteria:
* Serious and uncontrolled comorbidities；
* Expected lifetime is less than 1 month；
* Severe/critical;
* Other situations that are evaluated by researchers as not suitable for participating the study.
Criteria for discontinuation
* The subject could not benefit after treatment (discontinued patients could be analyzed according to the PP analysis set);
Withdrawal criteria (if any of the following items are required)
* The subject asked to withdraw from the study;
* The subject needs to withdraw from the study after clinical observation after discontinuing treatment;
* The subject died or lost to follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05855395
Study Brief:
Protocol Section:
NCT05855395