Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD7442 IM, Evusheld, AZD7442 IV
AZD7442 · 9 trials · 5 indications
Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 \< 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
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.
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
The serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants were evaluated. The serum concentrations for each scheduled time point were summarized by route of administration using appropriate descriptive statistics, based on the (Pharmacokinetic analysis) PK analysis set.
The Cmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The tmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The t1/2 of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The AUC0-last of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The AUC0-inf of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The tlast of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The %AUCex of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The CL/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The Vz/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The CL of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The Vss of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated.
Number of pediatric participants with AESI after a single IM or IV dose were evaluated. An AESI is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product.
The pharmacokinetic (PK \[AUCinf\]) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The AUCinf comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated. day\*micrograms per milliliter (day\*μg/mL)
The PK (AUClast) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The AUClast comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated.
The PK (Cmax) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The Cmax comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated.
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Measurement of white blood cell (WBC) count, red blood cell (RBC) count.
Measurement of prothrombin time, activated partial thrombin time (aPTT).
Measurement of glucose, protein, and blood.
Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.
Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).
To evaluate the safety and tolerability of AZD7442 administered IV or IM\_Adverse event and serious adverse event
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
To evaluate the single-dose PK of AZD7442.
The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.
| Arm | Type | Description |
|---|---|---|
| AZD7442 | EXPERIMENTAL | Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442. |
| Placebo | PLACEBO_COMPARATOR | Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo. |
| Sub-study AZD7442 Arm 1 | EXPERIMENTAL | Approximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 1 (\~ 12 month repeat dose interval): Participants who received AZD7442 300 mg IM on Day 1 of the parent study will receive a second dose of AZD7442 300mg IM on sub-study Day 1. |
| Sub-study AZD7442 Arm 2 | EXPERIMENTAL | Approximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 2(\~ 6 month repeat dose interval): Participants who received placebo on Day 1 of the parent study will receive their first dose of AZD7442 300mg IM on sub-study Day1 followed by a second dose on sub-study Day 183. |
| Sub-study AZD7442 Arm 3 | EXPERIMENTAL | A subset of Arm 1 and Arm 2 participants who will receive additional doses of AZD7442, 600mg, at Day 183 and Day 366 of the sub-study. |
| AZD7442 (co-formulation) | EXPERIMENTAL | Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1. |
| AZD8895 and AZD1061 (clonal cell line material) | ACTIVE_COMPARATOR | Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1. |
| AZD8895 and AZD1061 (cell pool material) | ACTIVE_COMPARATOR | Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1. |
| 300 mg AZD7442 IM | EXPERIMENTAL | Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection. |
| 300mg placebo IM | PLACEBO_COMPARATOR | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
| 600 mg AZD7442 IM | EXPERIMENTAL | Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection. |
| 600mg placebo IM | PLACEBO_COMPARATOR | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
| 300 mg AZD7442 IV | EXPERIMENTAL | co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion. |
| 300mg placebo IV | PLACEBO_COMPARATOR | co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
| 600 mg AZD7442 IV | EXPERIMENTAL | co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. |
| 600mg placebo IV | PLACEBO_COMPARATOR | co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| AZD7442 | DRUG | Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1. |
| Placebo | DRUG | Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1. |
| 600 mg AZD7442 IV | DRUG | Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion. |
| 600mg placebo IV | DRUG | Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion. |
| AZD8895 (clonal cell line material) | BIOLOGICAL | AZD8895 will be administered via IM route. |
| AZD1061 (clonal cell line material) | BIOLOGICAL | AZD1061 will be administered via IM route. |
| AZD8895 (cell pool material) | BIOLOGICAL | AZD8895 will be administered via IM route. |
| AZD1061 (cell pool material) | BIOLOGICAL | AZD1061 will be administered via IM route. |
| AZD7442 IM | DRUG | In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections. |
| Placebo IM | DRUG | In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. |
| AZD7442 IV | DRUG | In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. |
| Placebo IV | DRUG | In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. |
| AZD7442 300 mg IM(male) | BIOLOGICAL | Single dose of 300 mg of AZD7442 or saline placebo on Day 1. |
| AZD7442 600 mg IM (male) | BIOLOGICAL | Single dose of 600 mg of AZD7442 or saline placebo on Day 1. |
| AZD7442 300 mg IV (male and female) | BIOLOGICAL | Single dose of 300 mg of AZD7442 or saline placebo on Day 1. |
| AZD7442 1000 mg IV (male) | BIOLOGICAL | Single dose 1000 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 Progres...
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AZD7442 is an investigational monoclonal antibody developed for the prevention and treatment of COVID-19 caused by SARS-CoV-2. It has been studied across multiple clinical trials in healthy adults, pediatric participants, and Chinese populations. The program includes five completed trials with a total enrollment of 7,338 participants.
AZD7442 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical development program for this monoclonal antibody candidate.
AZD7442 has reached Phase 3 in its clinical development program. The overall program includes five completed trials, with no active trials currently listed. The trials span Phase 1, Phase 2, and Phase 3 and have enrolled a total of 7,338 participants.
AZD7442 has been evaluated in completed trials including NCT05437289, a Phase 1 study in healthy Chinese adults; NCT05281601, a Phase 1 pediatric pharmacokinetics and safety study; NCT05184062, a Phase 2 study in Chinese adults; and NCT05166421, a Phase 1 pharmacokinetic comparability study of the co-formulation versus individual antibodies.