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:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT04452812
Eligibility Criteria:
Inclusion Criteria (Donors):
* Signed informed consent
* At least positive for 1 q-PCR test for SARS-CoV-2
* 14 days of COVID-19 clinical remission
* Positive serologic test for SARS-CoV-2
* Requirements to donate according to NOM-253-SSA1-2012
* To accept sample storing for future study
Inclusion Criteria (Receptors):
* Signed informed consent provided by the patient, legal guardian or the health provider if not available
* Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients
* At least positive for 1 q-PCR test for SARS-CoV-2
* Patients with COVID-19 defined as severe or critically ill:
Severe: RF \> 30 bpm, oxygen saturation \<94%, Pa/FiO2 \<301, bilateral lung infiltrates that extends in \>50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory failure (PaO2 \<60 mmHg or SatO2 \<90% with FiO2 \>60%) and septic shock (MAP \<65 mmHg with vasoactive requirement, lactate \> 2 mmol/L and SOFA score \>1)
Exclusion Criteria:
* Positive pregnancy test
* Patients in lactation
* Informed consent not signed
* Patients involved in other treatment protocols
* Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule drugs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04452812
Study Brief:
Protocol Section:
NCT04452812