COVID-19 International Drug Pregnancy Registry (COVID-PR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Obstetric outcomes
研究概览
简要总结
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
详细描述
Rationale and background: Pharmaceutical companies, academic centers, and other organizations globally are developing monoclonal antibodies and antiviral drugs to treat COVID-19. Pregnant women will be treated with these medications which, for the most part, lack scientific evidence regarding safety for the mother and the developing offspring.
Objective: To estimate the effect that monoclonal antibodies and antiviral drugs indicated for mild, moderate, or severe COVID-19 have on obstetric, neonatal, and infant outcomes.
Endpoints: Risk of obstetric outcomes (spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery), neonatal outcomes (major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth), and infant outcomes until 12 months of age (developmental milestones [motor, cognitive, language, social-emotional, and mental health skills], height, weight, failure to thrive).
Study design: The COVID-PR is an international, non-interventional, post-marketing cohort study designed to collect safety data among pregnant and recently pregnant women treated with monoclonal antibodies or antiviral drugs for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. Follow-up continues until the infant's first year of age.
Population: The study population includes pregnant or recently pregnant women 18 years of age and older treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 at any time during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. Registration and participation via website especially developed for the COVID-PR are voluntary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant or recently pregnant (up to 30 days after the end of pregnancy) at time of enrollment
- •Age ≥18 years at time of enrollment
- •With mild to severe COVID-19 during pregnancy
- •Treated for COVID-19 with at least one of the medications included in Table 1 during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP or
- •Hospitalized and did not receive any pharmacological treatment specifically indicated for mild, moderate, or severe COVID-19 during pregnancy
- •Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
- •Signed the informed consent form and submitted the baseline module "COVID-19 Medications During This Pregnancy"
排除标准
- •● <18 years of age
研究组 & 干预措施
Exposed pregnant women
Pregnant or recently pregnant women 18 years of age and older treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 at any time during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
干预措施: Antiviral Agents (Drug)
Exposed pregnant women
Pregnant or recently pregnant women 18 years of age and older treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 at any time during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
干预措施: Monoclonal antibody (Drug)
结局指标
主要结局
Obstetric outcomes
时间窗: 1 year
Number of pregnant women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of pregnant women in the reference cohorts who experience spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery.
Neonatal outcomes
时间窗: 1 year
Number of newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of newborns of pregnant women in the reference cohorts who experience major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth.
Infant weight
时间窗: 1 year
Change in weight from birth to 3, 6, 9, and 12 months of age among newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among newborns of pregnant women in the reference cohorts.
Infant developmental milestones
时间窗: 1 year
Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among the offspring of pregnant women in the reference cohorts.
Infant height
时间窗: 1 year
Change in length from birth to 3, 6, 9, and 12 months of age among newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among newborns of pregnant women in the reference cohorts.
次要结局
未报告次要终点