Clinical trial: A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (NCT04634409)

Eligibility criteria:
Inclusion Criteria:

          -  Are currently not hospitalized

          -  Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat,
             malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with
             exertion

          -  Must have sample taken for test confirming viral infection no more than 3 days prior
             to starting the drug infusion

          -  Are men or non-pregnant women who agree to contraceptive requirements

          -  Understand and agree to comply with planned study procedures

          -  Agree to the collection of nasopharyngeal swabs and venous blood

          -  The participant or legally authorized representative give signed informed consent

        Exclusion Criteria:

          -  Body mass index (BMI) greater than or equal to (≥)35

          -  Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at
             sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of
             mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate ≥30
             per minute, heart rate ≥125 per minute

          -  Require mechanical ventilation or anticipated impending need for mechanical
             ventilation

          -  Have known allergies to any of the components used in the formulation of the
             interventions

          -  Have hemodynamic instability requiring use of pressors within 24 hours of
             randomization

          -  Suspected or proven serious, active bacterial, fungal, viral, or other infection
             (besides COVID-19) that in the opinion of the investigator could constitute a risk
             when taking intervention

          -  Have any co-morbidity requiring surgery within <7 days, or that is considered
             life-threatening within 29 days

          -  Have any serious concomitant systemic disease, condition or disorder that, in the
             opinion of the investigator, should preclude participation in this study

          -  Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility
             for this study

          -  Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
             days before dosing

          -  Have received treatment with a SARS-CoV-2 specific monoclonal antibody

          -  Have a history of convalescent COVID-19 plasma treatment

          -  Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2
             vaccine

          -  Have participated, within the last 30 days, in a clinical study involving an
             investigational intervention. If the previous investigational intervention has a long
             half-life, 5 half-lives or 30 days, whichever is longer, should have passed

          -  Are concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  Are pregnant or breast feeding

          -  Are investigator site personnel directly affiliated with this study
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 64 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