The KIN-FAST Trial (KIN001 For Accelerated Symptoms Termination) A 4-week Double-blind, Randomized, Placebo-controlled, Phase II Study Evaluating the Effects of Oral Pamapimod 150 mg With Pioglitazone 10 mg Daily on COVID-19 Evolution and Recovery in Non-hospitalized Patients Infected With SARS-CoV-2 (Severe Acute Respiratory Syndrome-coronavirus-2)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Kinarus AG
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- COVID-19 symptoms evaluation
研究概览
简要总结
Clinical trial on safety and efficacy of KIN001 in non-hospitalized patients with COVID-19.
详细描述
This is a prospective, double-blind, randomized and placebo-controlled phase II trial to evaluate the safety and efficacy of KIN001 in non-hospitalized patients suffering from COVID-19. Randomization to one of two treatment arms (KIN001 versus Placebo) is at a ratio of 1:1.
Patients will receive treatment for 14 days and followed for another 14 days. The primary outcome is patient reported COVID-19 symptoms, using the FDA questionnaire developed for assessing COVID-19-related symptoms in outpatients.
The trial will be conducted in Switzerland and Germany.
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
- •Diagnosis of symptomatic COVID-19 of less than 5 days' duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, OR a minimum total score of 6 points
- •Diagnosis of COVID-19 confirmed in the last 48 hours by a positive test for SARS-CoV-2 RNA by RT PCR or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum
- •No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons
- •Adult male or female patients aged ≥ 18 years
- •Females must have a negative pregnancy test or must be post-menopausal
- •Able to understand and willing to sign an IRB/IEC approved written informed consent document.
- •Able to understand and be available for daily phone calls to evaluate symptoms.
排除标准
- •Patients with an indication for hospitalization (e.g. SpO2 <92%)
- •Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment
- •Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
- •Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP.
- •Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), with hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- •Any use of CYP450 2C8 inducers (e.g. rifampicin)
- •Known or suspected active viral (including HIV, hepatitis B, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-
- •Virologic testing not required unless infection is suspected.
- •Pregnant or breastfeeding women
- •Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements as determined at the discretion of the investigator
- •Liver enzyme elevation more than 3x above normal in the last 4 weeks or at inclusion
- •Patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
研究组 & 干预措施
KIN001
75mg pamapimod oral tablet 5mg pioglitazone oral tablet twice daily for 14 days
干预措施: KIN001 (Drug)
Placebo
75mg pamapimod-placebo oral tablet 5mg pioglitazone-placebo oral tablet twice daily for 14 days
干预措施: KIN001-Placebo (Drug)
结局指标
主要结局
COVID-19 symptoms evaluation
时间窗: 28 days
Number of days alive with no score \> 1 in each of the symptoms and a maximum of 3 points in the total score\*, measured from inclusion to day 28 \*Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
次要结局
- COVID-19 time to recovery(28 days)
- COVID-19 related hospital admissions(28 days)
- Safety and tolerability assessing treatment emergent adverse events(28 days)
- Total evaluation of COVID-10 symptoms score(28 days)