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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT04513158
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
* Patients must also have the following indications for enrollment:
* i. D-Dimer \> 500 ng/ml FEU OR
* ii. IL-6\> 5 pg/mL
With any of the following:
* iii. Lymphocytes \< 0.8 103/ul OR
* iv. LDH \> 700 U/L OR
* v. CK \> 170 U/L OR
* vi. CRP \> 1.0 mg/dl OR
* vii. Ferritin \> 1000 ng/ml
AND one of the following:
* viii. Age over 60 years
* ix. Underlying Active Malignancy
* x. Cardiovascular Disease
* xi. Active Tobacco Use
* xii. History of Pulmonary Volume Reduction Surgery
* xiii. Hypertension
* Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease.
* Age ≥ 18 years.
* The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate.
* Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care.
* Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.
Exclusion Criteria:
* 4.2.1 Patients who do not meet above inclusion criteria are not eligible.
* 4.2.2 Patients may not be receiving any other investigational agents.
* 4.2.3 History of allergic reactions attributed to previous transfusion history.
* 4.2.4 Respiratory rate \>30/min
* 4.2.5 Blood oxygen saturation \<93%
* 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300
* 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04513158
Study Brief:
Protocol Section:
NCT04513158