Clinical trial: The Impact of Camostat Mesilate on COVID-19 Infection (NCT04321096)

Eligibility criteria:
Cohort 1)

          -  Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical
             assay) for SARS-CoV-2

          -  Less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19
             is suspected, less than 48 hrs since onset of symptoms

          -  Adolescents and adults age >=18 years

          -  Subject or legally authorized representative able to give informed consent

          -  Admitted to hospital

        Cohort 2)

          -  Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical
             assay) for SARS-CoV-2

          -  One or more of the following symptoms of COVID-19 infection: fever, cough,
             expectoration, shortness of breath, myalgia, fatigue, or head ache

          -  No more than 5 days since the beginning of symptom onset

          -  Adolescents and adults age >=18 years

          -  Subject (or legally authorized representative, for Cohort 1 only) able to give
             informed consent

          -  Do not require immediate hospitalization (newly diagnosed COVID-19 patients who are
             discharged within 24 hrs of hospital admission are eligible for enrollment)

          -  Must be willing to fill out a daily symptom diary

          -  Must be available for a daily phone call

          -  Must be willing to take their own temperature at least once a day

        Exclusion criteria

          -  Any condition that, in the Investigator's opinion, will prevent adequate compliance
             with study therapy (e.g. the patient is considered to be moribund within the next 72
             hrs or has uncontrolled substance abuse that prevents adherence to study medication).
             Patients needing ventilator treatment are eligible to be enrolled if they fulfill the
             other in/exclusion criteria.

          -  The following laboratory values at baseline (Day 0):

               -  Serum total bilirubin ≥3 ULN

               -  Estimated glomerular filtration rate (eGFR) ≤30 mL/min (based on serum
                  creatinine)

          -  Known hypersensitivity to Camostat Mesilate

          -  Women who are pregnant or breastfeeding, or with a positive pregnancy test as
             determined by a positive urine or blood beta- human chorionic gonadotropin test during
             screening or women of child bearing potential* who are unwilling or unable to use an
             acceptable method of contraception (combined estrogen and progestogen hormonal
             contraception (oral, intravaginal or transdermal), progesteron-only hormonal
             contraception (oral, injectable or implantable), intrauterine device or intrauterine
             hormone-releasing system) to avoid pregnancy during the study. Sexual abstinence will
             only be accepted in cases where this reflect the usual lifestyle.
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.
Subject must be at most 110 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? Entailment