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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04547660
Eligibility Criteria:
Inclusion Criteria:
1. Age equal to or greater than 18 yers;
2. Diagnosis of SARS-CoV-2 infection through nasal cavity or oropharynx swab RT-PCR;
3. Severe COVID-19 defined by the presence of at least 1 of the following:
A. Respiratory rate\> 30 breaths per minute in room air; B. Oxygen saturation (O2) ≤93% in room air; C. PaO2 / FiO2 ratio ≤300; D. Need for supplemental O2 to maintain O2 saturation\> 95%; E. Need for therapy with supplemental O2 by high flow catheter or non-invasive ventilation or invasive mechanical ventilation;
4. Onset of symptoms in a period not exceeding 14 days.
Exclusion Criteria:
1. Impossibility for any reason to perform the first plasma infusion within 14 days of the onset of symptoms;
2. Use of immunosuppressants for other underlying diseases, except corticosteroids for the SARS-CoV-2, in the last 30 days before enrollment;
3. Pregnancy;
4. History of serious adverse reactions such as transfusion anaphylaxis;
5. Participation in another interventional clinical trial;
6. Disagreement of attending physician;
7. Disagreement of the patient or legal representative to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04547660
Study Brief:
Protocol Section:
NCT04547660