NCT05706454招募中2 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection
KARE Biosciences7 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2022年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 7
- 主要终点
- Time to Clinical recovery (TTCR)
研究概览
简要总结
Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.
Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.
Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.
Phase 2
Primary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Phase 3
Primary Objective:
To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Long COVID [Follow-up Phase- Objectives- (Phase 2 & 3)]
- To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
- To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, Investigator and Outcome Assessor Blinded Method of concealment: Pharmacy-controlled Randomization
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of age 18 years and above.
- •Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
- •Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
- •Subjects meeting 8-point WHO Ordinal Scale 5 or 6
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following:
- •PCR positive in a sample collected < 72 hours prior to randomization; OR
- •PCR positive in sample collected ≥ 72 hours but < 10 days prior to randomization AND non-improving or progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •i. Note: In case if the subject is not having previous reports, a quantitative analysis will be performed
- •Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day
- •Agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through-out the study period
排除标准
- •Subject with immediately life-threatening SARS-CoV-2 infection.
- •Life-threatening disease is defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- •Subjects on invasive mechanical ventilation at screening or randomization.
- •Female subject who is pregnant, breastfeeding, or planning to become pregnant.
- •Subject having other clinically significant gastrointestinal (GI) disease/ GI surgery that in the opinion of the investigator would interfere with the absorption of Ramatroban or subject is unable to swallow oral medications.
- •Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigator's judgment.
- •Known HIV/Hepatitis B or Hepatitis C infection.
- •Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal).
- •Subject with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
- •Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit.
- •Subject with a history of life-threatening neoplasms within 5 years prior to the screening visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
研究组 & 干预措施
Ramatroban 75 mg tablet
Experimental
干预措施: Ramatroban (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Clinical recovery (TTCR)
时间窗: Baseline - Day 15
Rate of Serious Adverse Events (SAE)
时间窗: Baseline - Day 29
次要结局
- Change from baseline of inflammation and coagulation markers(Baseline- Day 29)
- Rate of mechanical ventilation or vasopressor therapy, or ECMO(Day 29)
- Duration of ICU stay(Baseline-Day 29)
- Composite endpoint of death or need for mechanical ventilation or ECMO(Baseline - Day 29)
- Ventilator free days(Baseline-Day 29)
- Mortality rate(Till Day 29)
- Occurrence of serious ventricular arrhythmia(censored at hospital discharge)
- Major or Clinically Significant Non-Major Bleeding(Baseline -Day 29)
- Duration of hospitalization(Baseline-Day 29)
- Number of subjects who had thrombotic events(Within Day 29)
- Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.(Baseline- Day 29)
- Total red blood cell units transfused(Baseline -Day 29)
研究者
研究点 (7)
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