EUCTR2020-003368-24-IT进行中（未招募）1 期
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults with COVID-19 - MK-4482 Ph 2/3 Study in Non-Hospitalized Adults with COVID-19
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 1,450 人开始时间: 2021年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,450
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. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection <=7 days prior to day of randomization.
- •2. Has initial onset of signs/symptoms attributable to COVID-19 for <=7 days prior to the day of randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization:
- •-Sore throat
- •-Nasal congestion
- •-Runny nose
- •-Shortness of breath or difficulty breathing with exertion
- •-Muscle or body aches
- •-Fever > 38.0°C
- •-Loss of smell
- •-Loss of taste
- •3. Has mild or moderate COVID-19; participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
- •4. Is willing and able to take oral medication.
- •5. Is male or female >=18 years of age, at the time of providing informed consent.
- •6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
- •Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •7.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual
- •intercourse as their preferred and usual lifestyle (abstinent on a longterm and persistent basis), for 28 days from start of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to the Protocol.
- •8.Participant (or legally acceptable representative) has provided documented informed consent for the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 year
排除标准
- •1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
- •2. Is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation).
- •3. Has any of the following conditions:
- •-HIV with a recent viral load >50 copies/mL or CD4 <200 cell/mm³
- •-Chemotherapy required within 6 weeks before randomization
- •-A neutrophilic granulocyte absolute count <500/mm3
- •-Autologous or allogeneic hematopoietic stem cell transplant recipient
- •4. Has a history of HBV or HCV infection with any of the following:
- •Cirrhosis
- •End-stage liver disease
- •Hepatocellular carcinoma
- •AST and/or ALT >3X upper limit of normal at screening
- •5. Has a platelet count <100,000/µL or received a platelet transfusion in the 5 days prior to randomization.
- •6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
- •7. Has a baseline heart rate of <50 beats per minute at rest.
- •8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
- •9. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to:
- •-Participants who are not expected to survive longer than 48 hours after randomization, or
- •-Participants with a recent history of mechanical ventilation, or
- •-Participants with conditions that could limit gastrointestinal absorption of capsule contents.
- •10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol.
- •11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.
- •12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
研究者
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