Clinical trial: A Longitudinal Study of COVID-19 Sequelae and Immunity (NCT04411147)

Eligibility criteria:
-  INCLUSION CRITERIA:

        In order to be eligible to participate in this study, all individuals must meet all of the
        following criteria:

          1. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          2. Age 18 years or older.

          3. Ability of participant to understand and the willingness to sign a written informed
             consent document.

          4. Hemoglobin of 9.0 gm/dl or higher

          5. Willingness to give consent for the storage of blood samples for research.

          6. Have a physician or clinic outside NIH to manage underlying medical conditions or
             agreeing to establish care with an outside physician or clinic for any medical
             conditions requiring treatment that may be diagnosed as a result of protocol
             participation.

        COVID-19 Survivor Group

          1. Documented prior COVID-19 as evidenced by:

               1. detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum or other
                  sample source with EUA/approval from the FDA; or

               2. a positive antibody test using an assay that has received emergency use
                  authorization (EUA) from the Food and Drug Administration (FDA) and a history
                  clinical manifestation compatible with COVID-19.

          2. Greater than 6 weeks since onset of COVID-19 symptoms and no fever for at least 1
             week. For individuals with asymptomatic infection, screening will not occur until at
             least 4 weeks after the last positive SARS-CoV-2 PCR or antigen test.

        COVID-19 Close Contact

          1. Living in the same household as a COVID-19 survivor during the time of illness or,
             being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period
             of time or having direct contact with infectious secretions of a COVID-19 case (e.g.,
             being coughed on).

          2. No diagnosis of COVID-19 or current symptoms suggestive of COVID-19

        EXCLUSION CRITERIA:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. Current abuse of alcohol or other drugs that, in the judgement of the Principal
             Investigator (PI) could interfere with patient compliance.

          2. Inability to travel to the NIH Clinical Center for study visits

          3. Any medical or mental health condition that, in the judgement of the PI, would make
             the volunteer unable to participate in the study.

          4. Positive SARS-CoV-2 PCR at screening visit.

          5. History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new
             or worsening respiratory symptoms (e.g. cough, dyspnea).

          6. Pregnancy

        INCLUSION OF VULNERABLE PARTICIPANTS:

        Pregnant Women will not be enrolled in the protocol. If a woman is pregnant at the time of
        screening she will not be enrolled until the end of her pregnancy because important
        baseline research assessments (e.g. leukapheresis, chest x-ray, pulmonary function testing)
        should not be done during pregnancy.

        Children will not be included in this study. Due to the rarity of COVID-19 in children (as
        of 4/11/2020 in Maryland, <2% of cases occurred in children), it would not be possible to
        recruit enough children to address the protocol research objectives. In addition, pediatric
        restrictions for the volume of blood permitted to be drawn for research purposes and the
        more than minimal risk of apheresis in children would severely limit the ability to conduct
        the immunologic studies described in this protocol.

        Participation of Employees

        NIH employees may be enrolled in this study as this population meets the study entry
        criteria.

        Neither participation nor refusal to participate as a participant in the research will have
        an effect, either beneficial or adverse, on the participant s employment or position at
        NIH.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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