Clinical trial: Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health (NCT04573062)

Eligibility criteria:
-  INCLUSION CRITERIA:

        For Phase A:

        1200 persons who are recovering from an acute COVID-19 infection will participate.
        Inclusion criteria for Phase A:

        Post-COVID-19 Convalescence (n=1000)

          1. Participants 18 and older

          2. Ability to provide informed consent

          3. Stated willingness to complete telephone interviews

          4. Reports having begun recovery from an acute COVID-19 infection within the last six
             months

          5. Provides documentation of a positive COVID-19 PCR or antibody test

        OR

        Post-COVID-19 Neurological Sequelae (n=100)

          1. Participants 18 and older

          2. Ability to provide informed consent

          3. Stated willingness to complete telephone interviews

          4. Reports having developed neurological symptoms as a consequence of an acute COVID- 19
             infection

          5. Provides documentation of a positive COVID-19 PCR or antibody test

        OR

        Test-Negative COVID-19 with Persistent Symptoms (n=100)

          1. Participants 18 and older

          2. Ability to provide informed consent

          3. Stated willingness to complete telephone interviews

          4. Reports having developed persistent symptoms as a consequence of an acute COVID-19
             infection

          5. Provides documentation of a clinical diagnosis of an acute COVID-19 infection from a
             medical practitioner OR meets the Clinical Criteria of the 2020 CDC Interim Case
             Definition for Probable COVID-19 infection.

          6. Has either negative or absent COVID-19 PCR testing for the documented COVID-19
             infection.

          7. Provides documentation of a negative COVID-19 antibody test.

        The elements of the 2020 CDC Interim Case Definition for Probable COVID-19 Infection used
        for this protocol will be the Clinical Criteria:

        Clinical Criteria:

        At least two of the following symptoms: fever (measured or subjective), chills, rigors,
        myalgia, headache, sore throat, new olfactory and taste disorder(s)

        OR

        At least one of the following symptoms: cough, shortness of breath, or difficulty breathing

        OR

        Severe respiratory illness with at least one of the following:

          1. Clinical or radiographic evidence of pneumonia, OR

          2. Acute respiratory distress syndrome (ARDS).

        AND

        No alternative more likely diagnosis.

        EXCLUSION CRITERIA:

        Exclusion criteria for Phase A:

          -  Not willing to provide personal identifying information to investigative team

          -  Cognitive impairment that is severe enough to limit consent capacity
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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? Entailment