This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
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 completed and 2 ongoing Phase I studies with AZD7442. -The Provent repeat dose open-label sub-study is initiated to assess the safety, PK and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the Provent study who may benefit from repeat dose of AZD7442.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
5,197
* Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183. * Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366
Single dose (× 2IM injections) of saline placebo on parent study Day 1.
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 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.
Time frame: 165 Days for primary analysis, 183 days for final analysis
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
Time frame: 457 Days, Final analysis
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
Time frame: 366 days
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
Time frame: 366 Days
The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
Time frame: 366 days
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Birmingham, Alabama, United States
Research Site
Tempe, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Cerritos, California, United States
Research Site
Fresno, California, United States
Research Site
Garden Grove, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Lancaster, California, United States
Research Site
Modesto, California, United States
Research Site
Victorville, California, United States
...and 79 more locations
To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
Time frame: 457 days
Incidence of ADA to AZD7442 in Serum
To evaluate ADA responses to AZD7442 in serum
Time frame: 457 days