Clinical trial: Collection of Anti-SARS-CoV-2 Immune Plasma (NCT04344977)

Eligibility criteria:
INCLUSION CRITERIA:

          1. Provide written informed consent before initiation of any study procedures.

          2. Age greater than or equal to 18 years old and less than or equal to 70 years old.

          3. Subjects must not be symptomatic, must be afebrile for ≥14 days, beyond 28 days of the
             resolution of their acute COVID-19 illness, and must enroll within 18 months of onset
             of illness, and must meet at least 1 of the following:

               -  History suggestive of resolved COVID-19-like illness (e.g., prior fever, dry
                  cough, and shortness of breath). OR

               -  History of positive test for SARS-CoV-2 (either serologic or RT-PCR) OR

               -  Documented anti-SARSCoV-2 neutralizing antibody titer of at least 1:80

          4. Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80

          5. Females must have a negative anti-HLA screening test

          6. Weight greater than or equal to110 pounds (50 kg)

          7. Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma
             donation

          8. Adequate peripheral venous access for plasma donation (as judged by the examiner)

          9. Willingness to have samples stored

        EXCLUSION CRITERIA:

          1. Any sign of active illness of any kind including COVID-19 illness (as judged by the
             investigator), including but not limited to:

               -  Subjective or documented fever (greater than or equal to 38°C)

               -  Dry cough

               -  Shortness of breath

          2. Participation in medical research that includes:

               -  Protocols that are currently ongoing or will start during the duration of this
                  study that require more than 100 mL of blood to be given in any 8-week period of
                  time

               -  Administration of any unlicensed drug within the last 1 month or during the
                  duration of this study, per investigation discretion

               -  Administration of any unlicensed vaccine within the last 12 months or during the
                  duration of this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction