Clinical trial: A Study of Immune Responses to the Virus That Causes COVID-19 (NCT04431414)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18 years or older.

          -  Test result indicating presence of SARS-CoV-2 virus. Sites must have results from
             assays that are approved as FDA-emergency use authorized or as standard-of-care by
             other applicable regional governing bodies. For timing of testing, please see group
             specific criteria below.

          -  Ability and willingness to provide informed consent.

          -  Willingness to have clinical research staff come to place of residence or hospital if
             needed.

          -  Willingness to be followed for the planned duration of the study.

          -  Assessment of understanding: volunteer demonstrates understanding of this study.

          -  Agreement to allow access to medical records.

          -  Asymptomatic participants:

               -  No current symptoms.

               -  No symptoms consistent with COVID-19 within 2 weeks prior to positive test
                  according to the clinical judgement of the investigating clinician. Symptoms
                  include, but are not limited to, fever, headache, sore throat, cough, dyspnea,
                  rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to
                  https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html for the
                  current list of symptoms consistent with COVID-19.

               -  Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
                  (target time) up to 10 days prior to enrollment (upper allowable window).

          -  Symptomatic (non-hospitalized) participants:

               -  Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment
                  (target time) up to 14 days prior to enrollment (upper allowable window).
                  Symptoms of COVID-19 to be determined by the clinical judgement of the
                  investigating clinician including-- but not limited to-- fever, headache, sore
                  throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia.
                  Please refer to
                  https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html for the
                  current list of symptoms consistent with COVID-19.

               -  Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
                  (target time) up to 10 days prior to enrollment (upper allowable window).

          -  Symptomatic (hospitalized) participants

               -  Participant hospitalized for COVID-19 within 3 days prior to enrollment (note:
                  there is no timeframe for either symptom onset or timing of SARS-CoV-2 PCR or
                  antigen testing for hospitalized participants)

        Exclusion Criteria:

          -  Any medical, psychiatric, occupational, or other condition that, in the judgment of
             the investigator, would interfere with, or serve as a contraindication to, protocol
             adherence or a volunteer's ability to give informed consent.
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