This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.
SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September 2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective interventions to prevent or treat COVID-19 remain limited in number and clinical experience is limited. Clinical management is limited to supportive care, consequently overwhelming resources of healthcare systems around the world. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 S 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 prevent and/or treat COVID-19. There is currently one ongoing Phase I study with AZD7442.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,131
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Time frame: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Time frame: 457 Days
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
Time frame: 183 Days
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies
Time frame: 366 Days
The Incidence of COVID-19-related Death Occurring After Dosing With IMP
Time frame: 366 Days
The Incidence of All-cause Mortality Occurring After Dosing With IMP
Time frame: 366 Days
Serum AZD7442 Concentrations, PK Parameters
Time frame: 457 Days
Incidence of ADA to AZD7442 in Serum
Time frame: 457 Days
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Research Site
Guntersville, Alabama, United States
Research Site
Tempe, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Bakersfield, California, United States
Research Site
Corona, California, United States
Research Site
Garden Grove, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Huntington Park, California, United States
Research Site
Modesto, California, United States
Research Site
Coral Gables, Florida, United States
...and 47 more locations