2025-521866-92-01招募中2 期
SON4PEM study: Sonlicromanol in post-COVID: A randomized, double-blind, placebo-controlled, phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fatigue symptoms measured at week 13 by the FAS
研究概览
简要总结
Reduction of post-COVID related fatigue measured with the FAS on week 13
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Any gender aged ≥18 ≤ 65 years. • A confirmed post-COVID as diagnosed by two experienced clinicians: o history of SARS-CoV-2 infection o symptoms consistent with post-COVID beginning after the index infection and continuing more than 6 months • Presence of post exertional malaise, according to the DSQ-PEM questionnaire. • Healthy (i.e. no symptoms present) prior to NAAT or serology-proven SARS-CoV-2 infection as determined by medical history). • Bell’s functionality score between from 20-70% • None of the included participants were admitted to the hospital during acute SARS-CoV-
- •Able and willing to provide written Informed Consent prior to screening evaluations and to attend study appointments within the specified time windows. • In the investigator's opinion, likely to comply with the protocol and able to adhere to the study requirements for the length of the study. • Stable exercise regimen for at least 4 weeks prior to randomization and must stay on a stable regimen for the duration of the study period (for participants who participate in a regular exercise regimen). • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective/adequate methods of contraception during study treatment. Highly effective contraception methods include: • Total sexual abstinence: if defined as refraining from heterosexual intercourse during the entire period of risk associated with study treatment. Reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. • Combined oral, intravaginal, transdermal, implanted, injected (estrogen and progestogen containing) hormonal contraception or progesterone only hormonal contraception associated with inhibition of ovulation. • Placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. • Vasectomy of the partner; vasectomized partner is considered a highly effective birth control method provided that partner is the sole sexual partner of the subject and that the vasectomized partner has received medical assessment of the surgical success.
排除标准
- •Treatment with an IMP for PMD within 3 months prior to screening or plans to use an IMP during the study. Surgery of gastrointestinal tract that might interfere with drug absorption. Or severe GI dysmotility which will impair appropriate IMP absorption in the opinion of the investigator. Participant has clinically significant respiratory disease and/or cardiac disease in the opinion of the investigator, or prior interventional cardiac procedure within 3 months prior to randomization. QTcF > 450 msec (men) or QTcF > 470 msec (women). Structural heart disease based on Echocardiography and/or abnormal conduction (QRS and/or PR > 120 msec), and/or repolarization, myocardial function (LVEF <52% in men and < 54% in women), symptomatic ischemic heart disease, and/or pathologic hypertrophy, that is not well controlled under current specialized care. Subjects with congestive heart failure class II and above should also be excluded. Family history of unexplained syncope or congenital long and short QT syndrome or sudden death. ECG evidence of acute ischemia, atrial fibrillation or active conduction system abnormalities. History of acute heart failure (within the last 3 months), (family) history of unexplained syncope or congenital long and short QT syndrome or sudden death. Higher degree of AV-blocks (II° or III°) in the absence of a pacemaker or ICD. In case QTcFridericia is >450ms (men) and >470ms (women) and a simultaneous bundle-branch-block is not present at screening then QTcF will be calculated using regular QT interval. In case LBBB or RBBB is present the modified QT interval should be calculated. Patient is excluded if ECG shows active acute coronary syndrome criteria as described by the American Heart Association and that are clearly a deviation from the subject’s baseline ECG. Participants with pacemaker or AICD. Recent history of unstable disease, inadequately controlled neurological manifestations or not recovered from stroke-like episodes including but not limited to stroke-like episodes within the last 6 months, hospitalized for status epilepticus within the last 6 months. Blood pressure >160/90 mmHg at screening or baseline confirmed by re-testing. ≥1 clinical laboratory test value outside the reference range, based on the blood and urine samples taken at the screening visit, that are of potential risk to the patient's safety. See protocol for specifications. Medical history of drug abuse as defined in the protocol. Within 4 weeks prior to screening, the use of certain medication and supplements (see protocol). Patient has psychiatric conditions such as schizophrenia, bipolar disorder or major depressive disorder that has not been under control within 3 months prior to screening. Patient has severe behavioral or cognitive problems that preclude participation in the study. Patient has undergone an inpatient hospitalization that precludes participation in the study, within the 30 days prior to the randomization. Patient has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments. Patient has clinically significant and unstable respiratory disease and/or cardiac disease, or prior interventional cardiac procedure within 3 months prior to randomization. Patient requires any ventilator support, including CPAP or BiPAP at night. Patient has severe vision impairment that may interfere with their ability to complete all study requirements. Active malignancy or any other cancer from which the patient has been disease-free for <5 years, except for curative treated localized non-melanoma skin cancer. Patient has a solid organ transplant and/or is currently receiving treatment with therapy for immunosuppression. History of active human immunodeficiency virus, hepatitis B or hepatitis C infection. Patient has BMI below 18.5 kg/m2 or above 35 kg/m2 at screening. Any active infection at the time of randomization. Pregnancy or breast feeding.
结局指标
主要结局
Fatigue symptoms measured at week 13 by the FAS
Fatigue symptoms measured at week 13 by the FAS
次要结局
- Secondary endpoints include improvement in various disease domains within long COVID on week 4, 8 and 13 using the SF-36 and the PROMIS cognitive function 8a score. In addition, physical improvement will be measured using the Repeated Handgrip Strength and the Amsterdam Cognition Scan on baseline and week 4, 8 and 13.
研究者
post COVID research information
Scientific
Amsterdam UMC Stichting
研究点 (1)
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