PACTR202203593113347已完成3 期
MK4482-013: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19
MSD Pty Ltd0 个研究点目标入组 150 人开始时间: 2022年2月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.The participant is a household contact of an index case. An index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have:a) A first detectable SARS-CoV-2 test result from a sample collected =5 days prior to randomization of the participant(s),AND
- •b)At least 1 of the following symptoms attributable to COVID-19: fever =38.0ºC,chills,cough,sore throat, shortness of breath or difficulty breathing with exertion,fatigue,nasal congestion,runny nose,headache,muscle or body aches,nausea,vomiting,diarrhea,loss of taste,or loss of smell, with symptom onset no earlier than 5 days prior to randomization of the participant(s).2.The participant does not have confirmed or suspected COVID-19.3.The participant is willing and able to take oral medication.4.The participant is male or female =18 years of age,at the time of providing documented informed consent.5. There are no contraceptive requirements for male participants per protocol.However,where applicable,male participants are only eligible to participate if they agree to follow local labelling (or local ethics or regulatory authority requirement) regardingcontraception.6. 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 OR •Is a WOCBP and:- Uses a contraceptive method that is highly effective (a low user dependency method OR a user dependent hormonal method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),during the intervention period and for at least 4 days after the last dose of study intervention.7.The participant’s index case (or legally acceptable representative of the index case) has provided documented informed consent/assent for the collection of COVID-19 documentation requirements.8. Documented informed consent.
排除标准
- •1. The participant has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms), within 6 months prior to randomization.2.The participant has either of the following conditions:-HIV with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS defining illness in the past 6 months.Note: Participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen.3.The participant 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.4.The participant has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
- •5.The participant 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 with conditions that could limit gastrointestinal absorption of capsule
- •contents.6.The participant has received, is taking, or is anticipated to require any prohibited therapies. 7. The participant has received a COVID-19 vaccine with the first dose 7 days or more prior to randomization.8.The participant 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.9.The participant is living in a household of more than 10 people. 10. 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
相似试验
未知
3 期
HARMONIZE GlobalHyperkalemiaJPRN-jRCT2080223490AstraZeneca
已完成
3 期
Saroglitazar 4 mg in Patients with Liver Disease.CTRI/2017/11/010511Cadila Healthcare Limited68
Unknown
3 期
Study in Patients With Hyperkalemia-HARMONIZE AsiaCTRI/2019/07/020166AstraZeneca AB
招募中
2 期
[M22-056] Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic MigraineMigraineJPRN-jRCT2031230217Otani Tetsuya520
进行中（未招募）
不适用
A study to assess the efficacy and safety of ON 01910.Na in combination with Gemcitabine vs. Gemcitabine alone in patients with a previously untreated metastatic pancreatic cancer.Metastatic Pancreatic CancerMedDRA version: 15.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864EUCTR2012-003547-29-HUOnconova Therapeutics Inc.364