EUCTR2020-003367-26-FR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 Hospitalized Adults with COVID-19 - MK-4482 Ph 2/3 Study in Hospitalized Adults with COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
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 = 10 days prior to randomization.
- •2. Had initial onset of signs/symptoms attributable to COVID-19 for =10 days prior to randomization and =1 sign/symptom attributable to COVID-19 present at randomization.
- •3. Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes).
- •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 long-term and persistent basis), during the intervention period and for at least 7 months after the last dose 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 (serum test is required) 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.
- •- Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19, estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant’s hospitalization. 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 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 years) yes
- •F.1.2.1 Number of subjects for this age range 845
排除标准
- •1. Has critical COVID-19 with any of the following:
- •- Respiratory failure defined based on resource utilization requiring at least one of the following:
- •Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen =0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- •- Shock (defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors)
- •- Multi-organ dysfunction/failure
- •2. Is on dialysis or has reduced eGFR <30 mL/min/1.73m2 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 an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive) or HCV infection (defined as detectable HCV RNA).
- •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,
- •- Participants who are expected to require mechanical ventilation within 48 hours after randomization, or
- •- Participants with a recent history of mechanical ventilation not associated with COVID-19, 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 the Protocol.
- •11. Is unwilling to abstain from participating in another interventional clinical trial through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.
- •12. Is anticipated to require transfer to a non-study hospital within 72 hours.
- •13. 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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