EUCTR2020-004719-28-GB进行中（未招募）1 期
A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19 - Phase 3 Double blind Study of AZD7442 or Placebo for Post-exposure Prophylaxis of COVID-19 in Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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