| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 |
|
| 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 through Day 183
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 COVID-19 through Day 366
Other 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 severe or critical symptomatic COVID-19
- To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
- To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
-To evaluate ADA responses to AZD7442 in serum |
|
| 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. Candidate for benefit from passive immunization with antibodies, defined as:
(a) Increased risk for inadequate response to active immunization (predicted poor
responders to vaccines), defined as;
o Elderly, ie, ≥ 60 years old
o Obese, ie, BMI ≥ 30
o Congestive heart failure
o Chronic obstructive pulmonary disease
o Chronic kidney disease, ie, GFR < 30 mL/min/1.73 m2
o Chronic liver disease
o Immunocompromised state from solid organ transplant, blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immunosuppressive medicines
o Intolerant of vaccine.
(b) Increased risk for SARS-CoV-2 infection, defined as those whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19, based on available risk assessment at time of enrollment. Examples include:
o Health care workers, including staff of long-term care facilities (including skilled nursing facilities, assisted living facilities, and independent living facilities for senior adults)
o Workers in industrial settings shown to have been at high risk for SARS-COV-2 transmission, including but not limited to meatpacking plants
o Military personnel residing or working in high density settings including but not limited to barracks, ships, or close-quarters working environments
o Students living in dormitory settings
o Others living in settings of similar close or high-density proximity
3. Medically stable defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the investigator.
4. 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 Day 1 and agree to continue through 365 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 agespecific 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 in the protocol from Day 1 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 child bearing potential must have a negative serum pregnancy test result at Visit 1 and throughout the study as indicated per the SoA
5. 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.
6. 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. |
|
| E.4 | Principal exclusion criteria |
1 Significant infection or other acute illness, including fever > 100°F (> 37.8°C) on the day
prior to or day of randomization.
2. History of laboratory-confirmed SARS-CoV-2 infection.
3. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
4. Known history of allergy or reaction to any component of the study drug formulation.
5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
6. 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.
7. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
8. Any other significant disease, disorder, or finding that 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.
9. Receipt of blood products or immunoglobulins, including mAbs, within 6 months, or 5 antibody half-lives if longer than 6 months, prior to screening
10. 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
11. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
12. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
13. Employees of the Sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoint is the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post dose of IMP through Day 183.
For safety; AEs, SAEs, MAAEs, and AESIs through 365 days post dose of IMP. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Key Secondary endpoint;
-The key secondary endpoint is the incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness through Day 366.
Other Secondary endpoint;
- 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 SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring post dose.
- The incidence of COVID-19-related Emergency Department visits occurring post dose.
-Serum AZD7442 concentrations.
-PK parameters if data permit.
-Incidence of ADA to AZD7442 in serum. |
|
| 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 | 11 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 29 |
| 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 |
| Belgium |
| France |
| Spain |
| United Kingdom |
| United States |
|
| 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 | 1 |
| E.8.9.1 | In the Member State concerned days | 15 |
| 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 | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
