Effect of ADAPT232 Supplementation on Recovery of Patients in Rehabilitation Period in Long COVID-19: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Length of home stay/ sick listed
研究概览
简要总结
The aim of this clinical trial of a fixed combination of standardized extracts from Rhodiola rosea roots, Schisandra chinensis berry and Eleutherococcus senticosus root (ADAPT-232) in COVID-19 patients is to demonstrate possible efficacy of adjuvant treatment with ADAPT-232 in decreasing the duration of the convalescence, alleviation of fatigue, headache, attention deficit, difficult and rapid respiration, depression, anxiety and other symptoms of Long COVID-19 during rehabilitation period.
详细描述
Rationale. Currently, numerous clinical trials on efficacy antiviral preparations in COVID-19 patients are in progress, however little is known on effective treatment of comorbid complications or COVID long-haulers during convalescence, particularly on fatigue, headache, attention deficit, and depression. The aim of this study is to assess eficacy of an adaptogenic preparation ADAPT-232 on recovery of COVID-19 Patients in rehabilitation period after discharge from Intensive Care Units.
Pathogenesis and progression of COVID-19 is multistep process, which requires correct therapeutic strategy on various steps of initiation of overall defense response to pathogen and its resolution. Consequently, effective prevention or treatment of COVID-19 requires pharmaceutical corrections of many components innate, adaptive immune system, phases I-III metabolizing enzymes of detoxifying and repair systems as well as on the SARS-Cov-2 virus' life cycle and proliferation. We suggest that It can be achieved by multitarget pharmaceutical intervention of herbal preparations that have polyvalent and pleiotropic actions on host defence systems, like adaptogens, which are known as natural stress-protective compounds or plant extracts that increase adaptability, resilience, and survival of organisms. In this context, complex mixtures of natural compounds (or herbal extracts) synergistically targeting multiple elements of molecular networks involved in inflammatory defence response are presumably more effective than the monodrugs, targeting only one receptor.
Adaptogenic preparations were tested in controlled clinical trials for the treatment of common cold and associated uncomplicated upper respiratory infections as well as for the prevention of common colds. The studies confirm their safety and efficacy presumably due to antiviral, anti-inflammatory and adaptogenic activity. Further studies are required to evaluate their efficacy in COVID-19 and other viral respiratory invidious diseases.
One more possible benefit of adaptogens in COVID-19 might be their beneficial effect during convalescence of patents. This indication for use is based on the results of a randomized, placebo controlled double blind study of Chisan/ADAPT-232 (a fixed combination of three adaptogenic plants Eleutherococcus senticosus - Rhodiola rosea and Schisandra chinensis) in pneumonia. The results obtained in that study clearly indicate that adjuvant treatment of pneumonia patients with Chisan (ADAPT-232) significantly decreases the period of antibiotic therapy required for recovery, decreasing the duration of the acute phase of the illness, and improves the mental performance of patients during the convalescence period with an accompanying improvement in the quality-of-life.
ADAPT 232® is a formulation used in different dosage forms for the enhancement of mental and physical capacities in case of tiredness or during convalescence. Chisan (ADAPT-232) has been on the Swedish market as a natural remedy since 1979.
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)
盲法说明
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
- •COVID-19 patients with confirmed diagnosis based on positive SARS-Cov-2 test and the symptom of at least three of Long COVID-19 symptoms including: fatigue, headache, respiration problems (dyspnea or polypnea), sweat, cognitive disorders (attention, memory, anxiety and depression), loss of smell (anosmia) and taste (ageusia), cough, pain in joints. muscles and chest.
- •Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission.
- •Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
- •Able to take medication alone.
- •Able to give informed consent.
排除标准
- •Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission and Long Covid Symptoms longer that 3 months.
- •Patient admitted already under invasive mechanical ventilation;
- •Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
- •Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
- •Tube feeding or parenteral nutrition.
- •Respiratory decompensation requiring mechanical ventilation.
- •Uncontrolled diabetes type
- •Autoimmune disease.
- •Pregnant or lactating women.
- •Taking antibiotics for a reason other than COVID-19 at enrollment;
- •Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
- •Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
- •Has active cancer;
- •Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
- •Already participating in another clinical trial;
- •Has any other condition that would prevent safe participation in the study.
结局指标
主要结局
Length of home stay/ sick listed
时间窗: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)
Time (days) at home / sick listed
Duration of symptoms of Long COVID:
时间窗: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)
Time (days) from randomization to symptoms disappear
Number of participants clinically recovered
时间窗: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)
Number of participants without symptoms of Long COVID
Severity of the Long COVID symptoms
时间窗: Change from baseline during the period of the treatment and follow up (trough 21 days after randomization)
Time from randomization to relief of total and individual Long COVID symptoms scores Patient will be assessed for changes in clinical signs: headache, fatigue, physical activity, depression and anxiety, anosmia, ageusia, hair loss, cough, fever, sweat, pain in muscles, chest, and joints. The medians and hazard ratio's will be measured and compared between groups)
次要结局
- Immune response marker(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Physical activity(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Hypercoagulation marker(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Inflammatory marker(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Cognitive performance score(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Severity of anxiety and depression(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
- Severity of anxiety(Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization))
研究者
Alexander Panossian
Head of Research and Development at Phytomed AB
Phytomed AB