Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AZD7442; Placebo
Intervention description: Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.; Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 910.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of COVID-19

Summary:

      This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat
      outpatient adults with COVID-19 and prevent either severe COVID-19 or death.
    

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 > 1 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.

          8. Male participants: Contraception for male participants is not required; however, to
             avoid the transfer of any fluids, all male participants must use a condom from Day 1
             and agree to continue through 90 days following administration of IMP.

          9. Women of childbearing potential must use one highly effective form of birth control.

        Exclusion Criteria:

          1. History or current hospitalization for COVID-19.

          2. Current need for hospitalization/immediate medical attention in a clinic/emergency
             room service

          3. Previous hypersensitivity, infusion related reaction, or 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 or expected administration immediately after
             enrollment.

          5. Current 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. Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids
             within 30 days prior to study entry, unless a stable dose is used for a chronic
             condition.

          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.

         10. Pregnant or breastfeeding women.