Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05780437 | AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) | PHASE3 | COMPLETED | 1,455 | — | — | Feb 10, 2021 | Jun 9, 2023 | Feb 4, 2025 | 124 | United States, Denmark +7 |
| NCT04723394 | Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults | PHASE3 | COMPLETED | 910 | — | — | Jan 28, 2021 | Oct 19, 2022 | Jul 5, 2023 | 103 | United States, Argentina +13 |
| NCT04625972 | Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults | PHASE3 | COMPLETED | 1,131 | — | — | Dec 2, 2020 | Jul 25, 2022 | Nov 21, 2023 | 57 | United States, United Kingdom |
| NCT04625725 | Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. | PHASE3 | COMPLETED | 5,197 | — | — | Nov 21, 2020 | Dec 8, 2023 | Dec 31, 2024 | 89 | United States, Belgium +3 |
| NCT04896541 | Phase I Double-blind, Placebo-controlled Study of AZD7442 | PHASE1 | COMPLETED | 40 | — | — | Mar 16, 2021 | Jun 14, 2022 | Jun 27, 2022 | 1 | Japan |
| NCT04507256 | AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19 | PHASE1 | COMPLETED | 60 | — | — | Aug 18, 2020 | Oct 19, 2021 | Oct 18, 2024 | 1 | United Kingdom |
The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days.
Ordinal outcome with 7 mutually exclusive categories
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.
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 plus SOC | EXPERIMENTAL | * AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion |
| Placebo plus SOC | PLACEBO_COMPARATOR | * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion |
| 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. |
| Name | Type | Description |
|---|---|---|
| AZD7442 | BIOLOGICAL | AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. |
| Placebo | BIOLOGICAL | Commercially available 0.9% sodium chloride solution |
| Remdesivir | BIOLOGICAL | Antiviral agent |
| 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: • Refer to the master protocol (NCT04501978) Exclusion Criteria: * Refer to the master protocol (NCT04501978) * Additional Exclusion Criteria: * Pregnant women * Nursing mothers * Women of child-bearing potential who are unwilling to acknowledge the strong advice to abs...