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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT04432103
Eligibility Criteria:
Inclusion Criteria:
Donors:
1. Age: \>18 and \<60 years
2. Body weight : \>60 kg
3. Confirmed previous SARS CoV-2 infection
4. negative SARS CoV-2 test result
5. 21 day without symptoms from the negative SARS CoV2 negative test
6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
7. Positive COVID-19 IgG antibodies
8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
9. Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.
Patients/recipients:
1. Age: \>18 years
2. Admitted to the ABC Medical Center facility for the treatment of COVID-19
3. Patients with severe or critical COVID-19
4. Informed consent provided by the patient or healthcare proxy
Exclusion Criteria:
Patients/recipients:
1\. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04432103
Study Brief:
Protocol Section:
NCT04432103