Clinical trial: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (NCT04427501)

Eligibility criteria:
Inclusion Criteria:

          -  Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)

          -  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. (Not applicable to participants in treatment arm 22.)

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

          -  Are males or females, including pregnant females who agree to contraceptive
             requirements

          -  Understand and agree to comply with planned study procedures

          -  Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to
             participants in treatment arms 20-21.)

          -  The participant or legally authorized representative give signed informed consent
             and/or assent

        Participants in treatment arms 7-9, 13-14, and 18-21 ONLY

          -  Are greater than or equal to (≥)18 years of age and must satisfy at least one of the
             following at the time of screening

               -  Are pregnant

               -  Are ≥65 years of age

               -  Have a body mass index (BMI) ≥35

               -  Have chronic kidney disease (CKD)

               -  Have type 1 or type 2 diabetes

               -  Have immunosuppressive disease

               -  Are currently receiving immunosuppressive treatment or

               -  Are ≥55 years of age AND have:

                    -  cardiovascular disease (CVD), OR

                    -  hypertension, OR

                    -  chronic obstructive pulmonary disease (COPD) or other chronic respiratory
                       disease

          -  Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the
             time of screening

               -  Are pregnant

               -  Have a body mass index (BMI) ≥85th percentile for their age and gender based on
                  CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm

               -  Have sickle cell disease

               -  Have congenital or acquired heart disease

               -  Have neurodevelopmental disorders, for example, cerebral palsy

               -  Have a medical-related technological dependence, for example, tracheostomy,
                  gastrostomy, or positive pressure ventilation (not related to COVID-19)

               -  Have asthma or reactive airway or other chronic respiratory disease that requires
                  daily medication for control

               -  Have type 1 or type 2 diabetes

               -  Have chronic kidney disease

               -  Have immunosuppressive disease, or

               -  Are currently receiving immunosuppressive treatment

        Participants in treatment arm 22 ONLY

        - Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age
        (inclusive) AND satisfy at least one of the following risk factors at the time of screening

          -  Are pregnant

          -  Have a BMI ≥85th percentile for their age and gender based on CDC growth charts,
             https://www.cdc.gov/growthcharts/clinical_charts.htm

          -  Have sickle cell disease

          -  Have congenital or acquired heart disease

          -  Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down
             syndrome (FAIR Health 2020; Spreat et al. 2020)

          -  Have a medical-related technological dependence, for example, tracheostomy,
             gastrostomy, or positive pressure ventilation (not related to COVID-19)

          -  Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory
             disease that requires daily medication for control

          -  Have type 1 or type 2 diabetes

          -  Have chronic kidney disease

          -  Have immunosuppressive disease, or

          -  Are currently receiving immunosuppressive treatment, or

          -  Are less than (<) one year of age.

          -  Have one or more COVID-19 symptoms

               -  Shortness of breath/difficulty breathing

               -  Fever

               -  Sore throat

               -  Nausea

               -  Diarrhea

               -  Tiredness

               -  Headache

               -  New loss of taste

               -  Nasal congestion/runny nose

               -  Chills

               -  Stomachache

               -  Vomiting

               -  Cough

               -  Muscle/body aches and pain

               -  New loss of smell

               -  Poor appetite or poor feeding (in babies)

        Exclusion Criteria:

          -  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
             greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19

          -  Require mechanical ventilation or anticipated impending need for mechanical
             ventilation due to COVID-19

          -  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 received convalescent COVID-19 plasma treatment

          -  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

          -  Mothers who are breast feeding

        Participants in Treatment Arm 22 ONLY

          -  Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the
             opinion of the investigator

          -  Are currently hospitalized for treatment of COVID-19. Other reasons for
             hospitalization are acceptable.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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