Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Dietary Supplement: Nutridrink ONS 200 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study<br>Patients of the group received supplemental nutritional support with Nutridrink ONS 200 ml, 2 bottles (400 ml) daily for 28 days from the date of inclusion. In a hospital setting, additional nutritional support will be added to the patient's standard hospital diet. After being discharged from the hospital, the patient will receive at his disposal the required amount of Nutridrink ONS 200 ml in amount of 400 ml per day and will take it in addition to his usual and habitual diet. The Nutridrink ONS 200 ml is recommended to be taken between main meals. | Dietary Supplement: Nutridrink ONS 200 ml<br>* Nutridrink is a high-protein, high-calorie formula for the specialized nutrition of patients with or at risk of malnutrition. The product can be used as an additional or sole source of nutrition<br>|
| Control<br>Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score, part Physical Health component according to the SF-36 questionnaire | SF-36 questionnaire | up to 4 weeks | 
| Quality of life score, part Mental Health component according to the SF-36 questionnaire | SF-36 questionnaire | up to 4 weeks | 
| Quality of life score Total Quality of Life according to the SF-36 questionnaire | SF-36 questionnaire | up to 4 weeks | 
| Change in handgrip (decanewton) strength between visits 3 and 1 | Hand grip measured with hand dynamometer | between inclusion and discharge from hospital (about 2-3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration (days) of the patient stay under respiratory support or in the intensive care unit | Medical record | during observation | 
| Total stay in the hospital (days) | Medical record | during observation | 
| Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale | PCFS is not validated but usefull tool to measure patients' functional status https://erj.ersjournals.com/content/56/1/2001494 | during observation | 
| Nutritional Impact Symptom (NIS) Check-list score | check-list and scale developed for cachexia patients and published in https://link.springer.com/article/10.1007/s13539-012-0099-x | during observation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, ICU, respiratory support, quality of life, physical recovery