Prospective Open-label Comparative in Two-group Investigator-initiated Low-interventional Study to Assess the Effect of Oral Nutritional Supplement (ONS) Nutridrink® 200 ml on the Ability of Patients With COVID-19 to Health Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 6
- 主要终点
- Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
研究概览
简要总结
The goal of this low-interventional study was to learn about the effect a nutritional supplement in patients with COVID-19 and respiratory support. The main questions it aimed to answer were:
- if additional nutrition support has an effect on recovery of physical health in patients with COVID-19;
- to examine the effect of additional nutrition support on quality of life of patients with COVID-19;
- to examine the effect of the additional nutrition support on hospitalization period of patients with COVID-19.
Participants were split into two groups. One group had the common hospital diet, another group in addition to the common diet was given with NutriDrink® 200 ml X 2 daily. During the observation period participants were asked to measure hand strength measured by hand grip tester and fill out the quality of life standard questionnaire SF-36. In addition, several routine blood tests were performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed new coronavirus infection COVID-19 (based on laboratory and/or computer tomography data);
- •Need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position);
- •Ability to take food spontaneously in the amount of 60% and more of energy and protein needs (possibility of spontaneous food intake will be determined with the three-swallow test; consumed food will be controlled with the "quarter of a plate" method);
- •The informed consent is signed by a patient for the study enrollment and processing of personal data.
排除标准
- •Diabetes mellitus;
- •Renal failure;
- •Hepatic failure;
- •Systemic disease;
- •Active cancer;
- •Poor survival prognosis.
- •Aggravation of a patient's condition requiring his transfer to enteral feeding and/or parenteral nutrition;
- •Occurrence of complications requiring surgical interventions;
- •Patient's transfer for treatment to another inpatient unit;
- •Complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting);
- •Withdrawal of the informed consent for the study enrollment and processing of personal data.
结局指标
主要结局
Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
时间窗: up to 4 weeks
SF-36 questionnaire
Change in handgrip (decanewton) strength between visits 3 and 1
时间窗: between inclusion and discharge from hospital (about 2-3 weeks)
Hand grip measured with hand dynamometer
Quality of life score, part "Physical Health component" according to the SF-36 questionnaire
时间窗: up to 4 weeks
SF-36 questionnaire
Quality of life score, part "Mental Health component" according to the SF-36 questionnaire
时间窗: up to 4 weeks
SF-36 questionnaire
次要结局
- Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale(during observation)
- Duration (days) of the patient stay under respiratory support or in the intensive care unit(during observation)
- Total stay in the hospital (days)(during observation)
- Nutritional Impact Symptom (NIS) Check-list score(during observation)