Clinical trial: Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults (NCT04723394)

Eligibility criteria:
Inclusion Criteria:

          1. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined
             by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg,
             oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.

          2. WHO Clinical Progression Scale score > 0 and < 4.

          3. Participant must be dosed with IMP no more than 7 days from self-reported onset of
             COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as
             the self-reported date of first reported sign/symptom.

          4. One or more of the following signs/symptoms must be present within 24 hours prior to
             Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with
             activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction
             or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or
             smell.

          5. Oxygenation saturation of ≥ 92% obtained at rest by study staff within 24 hours prior
             to Day 1 (unless participant regularly receives chronic supplementary oxygen for an
             underlying lung condition).

          6. Participant agrees not to participate in another clinical trial for the treatment of
             COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28
             days after entry into the study (whichever is earliest).

          7. Participant must be ≥ 18 years of age, provide informed consent and is able to comply
             with study requirements/procedures.

        Exclusion Criteria:

          1. History or current hospitalization for COVID-19.

          2. Need for hospitalization/immediate medical attention in a clinic/emergency room
             service

          3. Previous adverse reaction to any monoclonal antibodies or known allergy to components
             of the IMP or placebo.

          4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any
             time prior to entry into this study.

          5. Requirement or anticipated impending need for mechanical ventilation.

          6. Any significant disease, disorder or finding that may increase risk to the participant
             that might affect his/her ability to participate in this study.

          7. Received convalescent COVID-19 plasma treatment any time prior to entry into this
             study.

          8. Pregnant or breastfeeding women.

          9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or
             expected receipt of IMP during the study follow-up period, or concurrent participation
             in another interventional 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.


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