A Phase II/III, Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,188
- 试验地点
- 2
- 主要终点
- Time to sustained recovery (in days) from randomization up to Day 29.
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 in hospitalized patients with moderate to severe Coronavirus Disease 2019 (COVID-19). A total of about 1188 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.
详细描述
Coronavirus Disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The infectious agent that causes COVID 19 is a novel coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified during a recent outbreak in December 2019. Patients with COVID-19 have symptoms of fever, cough, and shortness of breath along with non-specific symptoms including myalgia and fatigue.
FB2001 is a small-molecule inhibitor of coronavirus 3CL protease (3CLpro). In two phase I clinical trials, we completed doses of FB2001 that were safe, and were projected to be effective in patients according to its pharmacokinetic profile.
This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 in hospitalized patients with moderate to severe Coronavirus Disease 2019 (COVID 19). A total of about 1188 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old, male or female.
- •Subjects hospitalized with moderate to severe COVID-19 with a category 4 or 5 on an 8-category ordinal scale.
- •Has laboratory-confirmed COVID-19 infection within 5 days prior to randomization.
- •Initial COVID-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to COVID-19 within 24 hours before randomization.
- •The underlying medical condition was well controlled prior to SARS CoV 2 infection and does not affect daily life.
- •Subject who did not receive COVID 19 (primary series or booster) vaccine within the 6 months prior to screening.
- •The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the Investigator or designee.
- •The subject is able to communicate satisfactorily with the Investigator and to participate in, and comply with, the requirements of the study.
- •The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
- •Negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. Women of childbearing potential (WOCBP) and Women of non-childbearing potential are eligible to participate. Both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of FB2001.
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose or who are not willing to use a highly effective method of contraception.
- •HIV-infected subjects with viral load greater than 400 copies/mL or CD4 count less than 200 cell/µL from known medical history within past 6 months of the Screening Visit.
- •Subject with moderate to severe hepatic impairment or acute liver failure.
- •Known severe kidney disease.
- •Participated in other intervention studies within 6 months.
- •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 who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation.
- •Subjects receiving any medications or substances that are strong inhibitors or inducers of CYP3A within 14 days of randomization.
- •Received, ongoing or planed treatment with other anti-SARS CoV 2 therapeutics (including but not limited to known anti-SARS CoV 2 antibodies, small molecule antivirals, etc., other than remdesivir).
- •Other conditions that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for the study.
- •Have known hypersensitivity to FB2001 or its excipients.
- •Any planned vaccine within 28 days following the last administration of FB2001 for Injection.
研究组 & 干预措施
FB2001 group
FB2001 will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC.
干预措施: FB2001 (Drug)
Placebo group
Placebo will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC.
干预措施: FB2001 placebo (Drug)
结局指标
主要结局
Time to sustained recovery (in days) from randomization up to Day 29.
时间窗: Up to Day 29
Day of sustained recovery is defined as the first day on which a subject is discharged from hospital, or hospitalized for infection-control or other non-medical reasons through Day 29
次要结局
- Proportion of participants with mechanical ventilation or all-cause-death(Through Day 29 and Day 60)
- Proportion of participants with sustained recovery on Day 6(On Day 6)
- Days of invasive mechanical ventilation/ECMO (if applicable)(Up to Day 29)
- Population pharmacokinetic (PK) parameters to be measured/analyzed, including AUC, Cmax and Ctrough(Day0-Day 5)
- Proportion of participants achieving SARS-CoV-2 virologic clearance on Day 3, 5, 8, 15 and 29(On Day 3, 5, 8, 15 and 29)
- Clinical status category as assessed by an 8-category ordinal scale daily while hospitalized and on Days, 15 and 29.(On Days 15 and 29)
- Duration of each targeted COVID-19 sign/symptom until discharge(Up to Day 29)
- Severity of each targeted COVID-19 sign/symptom until discharge(Up to Day 29)
- Days of supplemental oxygen (if applicable)(Up to Day 29)
- Viral load change (log10) from baseline on Day 3, 5, 8 and 15.(On Day 3, 5, 8 and 15)
- Duration of non-invasive ventilation/high-flow oxygen (if applicable)(Up to Day 29)
- Time to achieve SARS-CoV-2 virologic clearance(Up to Day 29)