EUCTR2020-006082-11-HU进行中（未招募）1 期
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)
Adagio Therapeutics Inc.0 个研究点目标入组 1,084 人开始时间: 2021年6月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,084
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
- •a. Ph 2: Is an adult aged 18 years and above
- •b. Ph 3: Is an adult aged 18 years and above or is an adolescent aged 12-17 years (inclusive) and weighing =40 kg at the time of screening
- •2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
- •3. Has had initial onset of one or more of the following self-reported COVID-19-related signs or symptoms within 5 days prior to randomization:
- •(temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
- •4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization
- •(temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
- •5. Is at high risk of disease progression defined as:
- •a. Age >55 years
- •b. Age 18 to =55 years with one or more stable preexisting medical conditions as follows
- •i. Obesity [BMI = 30 kg/m2]
- •ii. Diabetes (Type 1 or Type 2)
- •iii. Chronic kidney disease
- •iv. Chronic lung disease
- •v. Cardiac disease
- •vi. Sickle cell disease or thalassemia
- •vii. Solid organ or blood stem cell transplant recipients
- •viii. Other immunodeficiency due to underlying illness or immunosuppressant medication
- •ix. Down Syndrome
- •x. Stroke or cerebrovascular disease, which affects blood flow to the brain
- •xi. Substance use disorder
- •xii. Pregnant (Phase 3 only; after review Ph2 data by iDMC)
- •c. Age 12 to 17 years (inclusive) with one or more preexisting medical conditions as follows
- •i. BMI >85th percentile for age and gender based on CDC growth charts
- •ii. Diabetes (Type 1 or 2)
- •iii. Chronic kidney disease
- •iv. Sickle cell disease or thalassemia
- •v. Congenital or acquired heart disease
- •vi. Neurodevelopmental disorders
- •vii. A medically related technological dependence
- •viii. Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control
- •ix. Solid organ or blood stem cell transplant recipients
- •x. Other immunodeficiency due to underlying illness or immunosuppressant medication
- •xi. Substance use disorder
- •xii Pregnant (Ph 3 only: enrollment only after Ph2 data reviewed by iDMC)
- •6. Has been assigned female sex at birth and is of nonchildbearing potential. A female participant who is not of reproductive potential is eligible without requiring the use of contraception and pregnancy testing is not required. This includes female participants who have not undergone menarche or who are documented to be surgically sterile or postmenopausal. Follicle stimulating hormone is not required in postmenopausal females with amenorrhea for >2 years.
- •7. Has been assigned female sex at birth and is of childbearing potential and fulfills all the following criteria:
- •a. Has a negative urine or serum pregnancy test at Screening
- •b. Has practiced adequate contraception for or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1)
- •c. Has agreed to continue adequate contraception for sexual activity that could lead to pregnancy through 6 months following study drug administration
- •d. Is not currently breastfeeding
- •Adequate contraception for particip
排除标准
- •1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization
- •2. Has oxygen saturation (SpO2) =93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate =30 per minute, or heart rate =125 per minute.
- •3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation.
- •4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only.
- •5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- •6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients.
- •7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study.
- •8. Has a known active co infection (eg, influenza, urinary tract infection, etc).
- •9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days.
- •10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- •11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.
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