Official Title
A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
Brief 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.

Detailed Description

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.

Completed
COVID-19

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Brazil
Czechia
Germany
Hungary
Italy
Japan
Mexico
Peru
Poland
Russian Federation
Spain
Ukraine
United Kingdom
United States
Locations

Research Site
Jasper, Alabama, United States

Research Site
Tucson, Arizona, United States

Research Site
Long Beach, California, United States

Research Site
Northridge, California, United States

Research Site
Cutler Bay, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Pompano Beach, Florida, United States

Research Site
Chicago, Illinois, United States

Research Site
Lake Charles, Louisiana, United States

Research Site
Saint Louis, Missouri, United States

Research Site
La Vista, Nebraska, United States

Research Site
New York, New York, United States

Research Site
Charlotte, North Carolina, United States

Research Site
Charlotte, North Carolina, United States

Research Site
Statesville, North Carolina, United States

Research Site
Fargo, North Dakota, United States

Research Site
Columbus, Ohio, United States

Research Site
West Columbia, South Carolina, United States

Research Site
Dallas, Texas, United States

Research Site
Houston, Texas, United States

Research Site
Houston, Texas, United States

Research Site
Houston, Texas, United States

Research Site
Humble, Texas, United States

Research Site
Buenos Aires, Argentina

Research Site
Buenos Aires, Argentina

Research Site
Buenos Aires, Argentina

Research Site
Munro, Argentina

Research Site
Blumenau, Brazil

Research Site
Porto Alegre, Brazil

Research Site
Ribeirão Preto, Brazil

Research Site
Sorocaba, Brazil

Research Site
São Paulo, Brazil

Research Site
Hradec Kralove, Czechia

Research Site
Kolin, Czechia

Research Site
Svitavy, Czechia

Research Site
Berlin - Friedrichshain, Germany

Research Site
Berlin, Germany

Research Site
Berlin, Germany

Research Site
Frankfurt/Main, Germany

Research Site
Frankfurt, Germany

Research Site
Hamburg, Germany

Research Site
Hannover, Germany

Research Site
Koblenz, Germany

Research Site
Köln, Germany

Research Site
Mainz, Germany

Research Site
München-Pasing, Germany

Research Site
München, Germany

Research Site
Debrecen, Hungary

Research Site
Gyöngyös, Hungary

Research Site
Guastalla, Italy

Research Site
Milano, Italy

Research Site
Piacenza, Italy

Research Site
Pisa, Italy

Research Site
Roma, Italy

Research Site
Chiba-shi, Japan

Research Site
Hachioji-shi, Japan

Research Site
Iruma-Gun, Japan

Research Site
Kyoto-shi, Japan

Research Site
Maebashi-shi, Japan

Research Site
Narita-shi, Japan

Research Site
Sendai-shi, Japan

Research Site
Shinagawa-ku, Japan

Research Site
Shinagawa-ku, Japan

Research Site
Shinjuku-ku, Japan

Research Site
Chihuahua, Mexico

Research Site
Cuauhtemoc, Mexico

Research Site
Cuautitlan Izcalli, Mexico

Research Site
Ecatepec de Morelos, Mexico

Research Site
Guadalajara, Mexico

Research Site
Guadalajara, Mexico

Research Site
Mazatlán, Mexico

Research Site
Monterrey, Mexico

Research Site
Mérida, Mexico

Research Site
Tlalpan, Mexico

Research Site
Tlalpan, Mexico

Research Site
Lima, Peru

Research Site
Rzeszów, Poland

Research Site
Wołomin, Poland

Research Site
Moscow, Russian Federation

Research Site
Murmansk, Russian Federation

Research Site
Saint-Petersburg, Russian Federation

Research Site
Saint-Petersburg, Russian Federation

Research Site
Saint-Petersburg, Russian Federation

Research Site
Saint-Petersburg, Russian Federation

Research Site
Saint-Petersburg, Russian Federation

Research Site
Cabra, Spain

Research Site
Centelles (Barcelona), Spain

Research Site
Girona, Spain

Research Site
Madrid, Spain

Research Site
Málaga, Spain

Research Site
Dnipro, Ukraine

Research Site
Ivano-Frankivsk, Ukraine

Research Site
Kherson, Ukraine

Research Site
Blackpool, United Kingdom

Research Site
Bracknell, United Kingdom

Research Site
Bristol, United Kingdom

Research Site
Cambridge, United Kingdom

Research Site
Connor Downs, United Kingdom

Research Site
Highgate, United Kingdom

Research Site
Leicester, United Kingdom

Research Site
Preston, United Kingdom

Research Site
Rochdale, United Kingdom

NCT Number
Keywords
Treatment of COVID-19
MeSH Terms
COVID-19
Cilgavimab and tixagevimab drug combination