A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 680
- 试验地点
- 32
- 主要终点
- Change in the Mean FSS Score.
研究概览
简要总结
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
详细描述
Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.
After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.
If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.
The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of either gender aged 18 to 65 years inclusive.
- •Patients within 4-12 weeks of the confirmed COVID-19 onset .
- •Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.
- •Presence of asthenia (≥36 on the FSS scale).
- •Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).
- •Presence of a signed information sheet and informed consent form for participation in a clinical trial.
排除标准
- •History / suspicion of cancer of any localization (with the exception of benign neoplasms).
- •More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).
- •Cerebrovascular diseases with the development of moderate to severe cognitive impairments.
- •Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- •Myocardial infarction, stroke in the previous 6 months.
- •Nervous system disorders with persistent neurological impairment.
- •Autoimmune diseases.
- •Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.
- •Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
- •Hypersensitivity to any of the components of the study drug.
- •Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- •Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential).
- •Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..
- •Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
- •Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.
- •Participation in other clinical studies within 3 months prior to enrollment in the study.
- •Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
研究组 & 干预措施
Prospekta
Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved.
干预措施: Prospekta (Drug)
Placebo
Tablet for oral use. Placebo using Prospekta scheme.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Mean FSS Score.
时间窗: after 4 weeks of treatment
Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
次要结局
- Change in Distance of the 6-minute Walk Test.(after 4 weeks of treatment)
- Change in the Severity of Anxiety on the HADS Subscale.(after 4 weeks of treatment)
- Change in the Severity of Depression on the HADS Subscale.(after 4 weeks of treatment)
- Change in the Mean FSS Score Within Follow-up Period.(after 4 weeks of treatment and after 4 weeks of follow-up at week 8)
- Change in Distance of the 6-minute Walk Test Within Follow-up Period.(after 4 weeks of treatment and after 4 weeks of follow-up at week 8)
- Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.(after 4 weeks of treatment and after 4 weeks of follow-up at week 8)
- Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.(after 4 weeks of treatment and after 4 weeks of follow-up at week 8)
- Changes in Vital Signs (Pulse Rate (Heart Rate)).(after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.)
- Changes in Vital Signs (Respiration Rate (Breathing Rate)).(after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8))
- Changes in Vital Signs (Blood Pressure).(after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8).)
- Presence of Adverse Events (AEs).(8 weeks)
- The Severity of AEs.(8 weeks)
- The Outcome of AEs.(8 weeks)
- AEs Causal Relationship to the Study Drug.(8 weeks)