Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 34
- 主要终点
- Part A - Determination of the Safety and Tolerability of Two Dose Levels and Selection of an Upamostat Dose for Part B
研究概览
简要总结
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.
详细描述
Patients will be seen in a medical facility (ER or COVID-19 clinic) for initial evaluation. Consenting, diagnostically-confirmed COVID-19 patients not in need of hospitalization per investigator assessment and who meet all other inclusion and exclusion criteria will be randomized to treatment and provided with medication and home monitoring devices, and instructed in drug administration and use of the devices. They will take medication daily for two weeks, complete a smartphone-based questionnaire, provide additional monitoring information via devices provided periodically over an 8-week period. Patients will be seen at home by a study nurse or return to the clinic after 2, 4 and 8 weeks on study ("follow up" visits); additional televisits will also be conducted. At the follow up visits nasal swab specimens for COVID-19 PCR and blood specimens for safety labs and disease markers will be collected.
In part A of the study, patients will be randomized 1:1:1 to one of two doses of upamostat or placebo. Based on safety results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs placebo.
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
- •Patients with symptomatic, diagnostically confirmed COVID-19, per RT-PCR or antigen assay of respiratory tract sample.
- •Patient must have either become symptomatic or found positive by RT-PCR or antigen assay within 5 days, whichever is greater, of randomization.
- •Patients must fill out a baseline questionnaire which is reviewed by study personnel to determine eligibility.
- •Males and females ≥age 18 years.
- •Oxygen saturation by pulse oximeter ≥92% on room air
- •Negative urine or serum pregnancy test (if woman of childbearing potential).
- •Females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods during the study and for at least two months after the last dose of study medication.
- •Ability to complete the daily diary independently.
- •The patient must give informed consent
排除标准
- •Patient is in need of acute hospitalization per clinician assessment.
- •Pregnant or nursing women.
- •Unwillingness or inability to comply with procedures required in this protocol.
- •Patient requires supplemental oxygen.
- •Patient is currently receiving, has received within the past 7 days or is expected to receive during the course of the study remdesivir, or other specific antiviral or anticytokine therapy for COVID-19, other than therapeutic monoclonal antibodies allowed or approved in the region in which the patient lives, or systemic corticosteroid equivalent to ≥20 mg daily prednisone/3 mg dexamethasone daily.
- •Patient is currently receiving or has received within 30 days prior to screening any other investigational agent for any indication, including approved agents given for investigational indications (e.g., anti-cytokine treatments).
- •Patient is currently taking or is expected to start taking warfarin, apixaban (Eliquis), or rivaroxaban (Xarelto). Patients may be taking or start on study dabigatran (Pradaxa), standard or low molecular weight heparin.
结局指标
主要结局
Part A - Determination of the Safety and Tolerability of Two Dose Levels and Selection of an Upamostat Dose for Part B
时间窗: 57 days
This is a qualitative measure that takes into account safety and tolerability based on the relative incidence and severity (CTCAE v 5.0 criteria) of adverse events, both clinical and laboratory (SOC=investigations) in each active treatment group as compared to placebo. In addition, toxicities (i.e., adverse events considered at lease possible related to study medication) resulting in dose reductions or discontinuation of therapy will be tabulated and compared among treatment groups.
次要结局
- Development of New Disease-related Symptoms and/or Pneumonia on Study(57 days)
- Hospitalization or Death From Any Cause by End of Study(57 days)
- Time to Sustained Recovery From Symptomatic Illness for Part A (Protocol Definition)(57 days)
- Hospitalization or Death For COVID With Presence of Concerning Conditions(57 days)
- Time to Sustained Recovery From Symptomatic Illness - Part A (SAP Definition)(57 days)
- Proportion of Patients Who Are PCR-negative at Day 8 From the Start of Treatment(8 days)
- Proportion of Patients Who Are PCR-negative at Day 57 From the Start of Treatment(57 days)
- Changes in D-dimer Levels, From Baseline to Day 57(57 days)