A Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Multi-Centre, Adaptive Phase II/Phase III Study to Evaluate the Efficacy and Safety of Ramatroban along with the standard of care in Hospitalized Subjects with SARS-CoV-2 Infection.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 22
- 主要终点
- Phase II
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled parallel-design, multicenter, adaptive Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in hospitalized subjects with SARS-COV-2 infection along with the standard of care.
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 II
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 III
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 II &III)]
-
To examine lipid mediators, specifically thromboxane A2, PGD2, 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
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects of age 18 years and above.
- •2.Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
- •3.Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
- •4.Subjects meeting 8-point WHO Ordinal Scale 5 or 6 5.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: a.PCR positive in a sample collected < 72 hours prior to randomization; OR b.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 6.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
- •7.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
- •1.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 2.Subjects on invasive mechanical ventilation at screening or randomization.
- •3.Female subject who is pregnant, breastfeeding, or planning to become pregnant.
- •4.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.
- •5.Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigator’s judgment.
- •6.Known HIV/Hepatitis B or Hepatitis C infection.
- •7.Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal).
- •8.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.
- •9.Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit.
- •10.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.
结局指标
主要结局
Phase II
时间窗: Phase II | 1. Baseline - Day 29 | Phase III | 1. Baseline - Day 15
1. Rate of Serious Adverse Events (SAE)
时间窗: Phase II | 1. Baseline - Day 29 | Phase III | 1. Baseline - Day 15
Phase III
时间窗: Phase II | 1. Baseline - Day 29 | Phase III | 1. Baseline - Day 15
1. Time to Clinical recovery (TTCR)
时间窗: Phase II | 1. Baseline - Day 29 | Phase III | 1. Baseline - Day 15
次要结局
- Phase II & III(1. Composite endpoint of death or need for mechanical ventilation or ECMO)