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.
A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of
atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe,
with over 35 million confirmed cases reported and more than one million associated deaths
according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare
systems with significant socioeconomic impacts. Effective interventions to prevent or treat
COVID-19 remain few in number and clinical experience is limited.
There is an urgent need to rapidly evaluate treatments in the non-hospitalized setting to
prevent progression and reduce serious complications of COVID-19, as well as its
transmission.
As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike
protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to
bind to receptors on human cells. By targeting this region of the virus's spike protein,
antibodies can block the virus's attachment to human cells, and, therefore, is expected to
block infection. Amino acid substitutions have been introduced into the antibodies to both
extend their half-lives, which should prolong their potential prophylactic benefit, and
decrease Fc effector function in order to decrease the potential risk of antibody-dependent
enhancement of disease.
AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for
administration to treat or prevent COVID-19. There are currently one ongoing Phase I study
and two ongoing Phase III studies with AZD7442, in addition to this treatment study.
Enrollment of up to approximately 1700 participants is planned.
Drug: AZD7442
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
Other Name: Combination of 2 mAbs (AZD8895 and AZD1061)
Drug: Placebo
Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
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.
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Jasper, Alabama, United States
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Tucson, Arizona, United States
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Long Beach, California, United States
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Northridge, California, United States
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Cutler Bay, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Pompano Beach, Florida, United States
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Chicago, Illinois, United States
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Lake Charles, Louisiana, United States
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Saint Louis, Missouri, United States
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La Vista, Nebraska, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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West Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Munro, Argentina
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Blumenau, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Sorocaba, Brazil
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São Paulo, Brazil
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Hradec Kralove, Czechia
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Kolin, Czechia
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Svitavy, Czechia
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Berlin - Friedrichshain, Germany
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Berlin, Germany
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Berlin, Germany
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Frankfurt/Main, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hannover, Germany
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Koblenz, Germany
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Köln, Germany
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Mainz, Germany
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München-Pasing, Germany
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München, Germany
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Debrecen, Hungary
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Gyöngyös, Hungary
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Guastalla, Italy
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Milano, Italy
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Piacenza, Italy
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Pisa, Italy
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Roma, Italy
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Chiba-shi, Japan
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Hachioji-shi, Japan
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Iruma-Gun, Japan
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Kyoto-shi, Japan
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Maebashi-shi, Japan
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Narita-shi, Japan
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Sendai-shi, Japan
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Shinagawa-ku, Japan
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Shinagawa-ku, Japan
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Shinjuku-ku, Japan
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Chihuahua, Mexico
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Cuauhtemoc, Mexico
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Cuautitlan Izcalli, Mexico
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Ecatepec de Morelos, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mazatlán, Mexico
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Monterrey, Mexico
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Mérida, Mexico
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Tlalpan, Mexico
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Tlalpan, Mexico
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Lima, Peru
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Rzeszów, Poland
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Wołomin, Poland
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Moscow, Russian Federation
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Murmansk, Russian Federation
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Saint-Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Cabra, Spain
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Centelles (Barcelona), Spain
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Girona, Spain
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Madrid, Spain
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Málaga, Spain
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kherson, Ukraine
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Blackpool, United Kingdom
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Bracknell, United Kingdom
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Bristol, United Kingdom
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Cambridge, United Kingdom
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Connor Downs, United Kingdom
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Highgate, United Kingdom
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Leicester, United Kingdom
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Preston, United Kingdom
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Rochdale, United Kingdom