| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10051905 |
| E.1.2 | Term | Coronavirus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo |
|
| E.2.2 | Secondary objectives of the trial |
Key Secondary
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
Secondary
-To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
-To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related death
-To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of all-cause mortality
-To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
-To evaluate ADA responses to AZD7442 in serum |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Participant must be ≥ 18 years of age at the time of signing the informed consent.
2. Participants will be adults with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic, who are therefore at appreciable risk of imminently developing COVID-19, based on available risk assessment at time of enrollment, within any of the following settings:
-Long-term care facilities, including skilled nursing homes, assisted living homes, independent living residences for the elderly. Residents, health care workers in such facilities, and other staff of such facilities are eligible under this criterion. For participants entering the study from these settings, “potential exposure to a specific identified individual with laboratory-confirmed SARS-COV-2 infection" is defined to mean the occurrence of SARS-COV-2 infection, symptomatic or asymptomatic, in another resident of the facility or in a staff member of the facility.
-Industrial settings shown to have been at high risk for SARS-COV-2 transmission, including but not limited to meatpacking plants. Workers in such facilities are eligible under this criterion. -Military settings including but not limited to barracks, ships, or other close-quarters working environments. Military and civilian personnel exposed in such settings are eligible.
-Health care facilities. Health care workers and other staff exposed in such setting are eligible under this criterion.
-University or college dormitories. Students exposed in such setting are eligible.
Household contacts. Any adult living in the same household as an index case are eligible under this criterion.
-Other settings of similar close or high-density inter-personal proximity. The potential for exposure in such settings may be assessed on a case-by-case basis by investigators. Individuals exposed in such settings are eligible under this criterion.
3. Prior to enrollment, participants must not have had COVID-19 symptoms, as described in Table 7 in protocol, within 10 days of dosing.
4. Negative result from point of care SARS-CoV-2 serology testing at screening.
5. Contraceptive use by men or women:
a. 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 Day1 and agree to continue through365 days following administration of the IMP.
b. Female Participants
-Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age specific requirements apply:
o Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.
o Women ≥50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
- Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from Day1 and agree to continue through 365 days following administration of the IMP. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of childbearing potential must have a negative serum pregnancy test result at Visit 1 and throughout the study as indicated per the SoA.
6. Able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative)based on the assessment of the investigator.
7. If able, signed informed consent. Ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. |
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| E.4 | Principal exclusion criteria |
1. History of laboratory-confirmed SARS-CoV-2 infectionor SARS-CoV-2 seropositivityat screening.
2. History of infection with severe acute respiratorysyndrome (SARS)or Middle East respiratory syndrome (MERS).
3. Known history of allergy or reaction to any component of the study drug formulation.
4. Previous hypersensitivity, infusion-related reaction,or severe adverse reaction following administration of a mAb.
5. Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow-up.
6. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
7. Any other significant disease, disorder, or finding that, in the judgement of the investigator, may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
8. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
9. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
10. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
11. Employees of the Sponsor involved planning, executing, supervising,
or reviewing the AZD7442 program, clinical study site staff, or any other
individuals involved with the conduct of the study, or immediate family
members of such individuals.
12. In nations, states, or other jurisdictions that for legal or ethical
reasons bar the enrollment of participants who lack capacity to provide their own informed consent,such subjects are excluded. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post dose of IMP to Day 183
Safety Endpoint : AEs, SAEs, MAAEs, and AESIs through 365 days post dose of IMP. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| The Primary Efficacy endpoint will be evaluated by Day183 and Safety endpoints on Day 366 |
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| E.5.2 | Secondary end point(s) |
Key Secondary endpoints:
The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP.
Other Secondary endpoints:
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.
The incidence of COVID-19-related death occurring after dosing with IMP.
The incidence of all-cause mortality occurring after dosing with IMP. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 10 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| United States |
| United Kingdom |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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