Clinical trial: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (NCT04822701)

Eligibility criteria:
Inclusion criteria phase II and III:

          -  ≥ 18 years old, males and females

          -  Signed and dated written informed consent in accordance with International Council on
             Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to
             admission to the trial

          -  Documentation of laboratory-confirmed Severe acute respiratory syndrome coronavirus 2
             (SARS-CoV-2) infection, as determined by a molecular test (antigen or nucleic acid)
             from any respiratory tract specimen (nasopharyngeal (NP) or nasal swab or saliva)
             collected no more than 72 hours prior to start of treatment

          -  Patients experienced mild to moderate Coronavirus Disease 2019 (COVID-19)-related
             symptoms or measured fever for no more than 5 days prior to start of treatment where
             symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath
             at rest or during activity, sore throat, body pain or muscle pain/ aches, chills,
             headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea,
             vomiting, or dysgeusia

          -  One or more of the following signs/symptoms present on day of start of treatment:
             fever, feeling feverish, fatigue, cough, shortness of breath at rest or during
             activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal
             obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or
             dysgeusia

          -  Women of childbearing potential (WOCBP) and men able to father a child must be ready
             and able to use highly effective methods of birth control per ICH M3 (R2) that result
             in a low failure rate of less than 1% per year when used consistently and correctly

        Exclusion criteria phase II and III:

          -  Body weight of less than 40 kg

          -  Severe or critical COVID-19 including at least one of

               -  Oxygen saturation (SpO2) ≤ 93 % on room air or on their usual level of oxygen
                  supplementation in case of chronic oxygen use

               -  Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to
                  fractional inspired oxygen (FiO2) < 300 (in case arterial blood sample was taken)

               -  History of hospitalization for COVID-19

               -  Current or imminent need for hospitalization or immediate medical attention in
                  the clinical opinion of the site investigator. Does not include patients
                  hospitalized for isolation only

          -  Receipt of intravenous immunoglobulin within 12 weeks prior to Visit 2

          -  Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2

          -  Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2

          -  Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2

          -  Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit
             2

          -  Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to
             Visit 2 unless used for chronic condition Further exclusion criteria apply.

        Exclusion criterion phase III only:

        - Previous enrolment in this trial. Patients participating in Phase II are not eligible for
        Phase III. Re-screening is allowed once, for repeat of Quantitative Reverse Transcription
        Polymerase chain reaction (RT-qPCR) or antigen SARS-CoV-2 test, if required. The test
        method used for initial screening (RT-qPCR or antigen) should be used for re-screening.
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? 1