Clinical trial: Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up (NCT04830852)

Eligibility criteria:
Inclusion Criteria:

        Survivors and household contacts:

        In order to be eligible to participate in this study as a survivor or household contact, an
        individual 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. Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).

          3. Willing to allow storage of samples and data for future research.

          4. At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical
             conditions, or agrees 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.

        In addition, an individual must meet all criteria for one of the following cohorts.

        Symptomatic survivor cohort (including MIS-C):

          1. Documented prior COVID-19 or MIS-C as evidenced by one of the following:

               1. detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other
                  sample source with Emergency Use Authorization (EUA)/approval from the US Food
                  and Drug Administration (FDA) and a history of clinical manifestation compatible
                  with COVID-19*; or

               2. positive SARS-CoV-2 antibody test using an assay that has received EUA from the
                  FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of
                  clinical manifestation compatible with COVID-19*; or

               3. meeting CDC case definition for MIS-C (see Appendix 1).

          2. Onset of COVID-19/MIS-C symptoms is at least 4 weeks before screening. *one or more of
             the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes",
             diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia,
             rhinorrhea.

        Asymptomatic survivor cohort:

          1. Documented prior SARS-CoV-2 infection as evidenced by one of the following:

               1. detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other
                  sample source with EUA/approval from the FDA without history of clinical
                  manifestation compatible with COVID-19; or

               2. positive SARS-CoV-2 antibody test using an assay that has received EUA from the
                  FDA without history of clinical manifestation compatible with COVID-19*.

          2. Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before screening. *one or
             more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes",
             diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia,
             rhinorrhea.

        Household contact (control) cohort:

          1. Lived in the same household as a participant with SARS-CoV-2 infection during the time
             of illness, or was within approximately 6 feet (2 meters) of the participant 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 SARS-CoV-2 infection or current symptoms suggestive of COVID-19.

        Parents and guardians:

        In order to participate in this study as a parent or guardian, an individual must meet all
        of the following criteria:

          1. Is a parent or guardian of a participant enrolled as a survivor or household contact.

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

          3. Willing to allow storage of data for future research.

        Exclusion Criteria:

        Survivors and household contacts:

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

          1. Any symptoms suggestive of an ongoing infection within 15 days of screening, including
             but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g.,
             cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea,
             vomiting, diarrhea or abdominal pain).

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

          3. Pregnancy.

        Parents and guardians:

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

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

        Co-enrollment: Participants may be co-enrolled in other clinical studies, including
        observational studies and therapeutic trials. However, the study staff should be informed
        of co-enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers

Subject must be at most 21 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? 0