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| Name | Class |
|---|---|
| Danone Nutricia | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | 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. |
| |
| Control | Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutridrink ONS 200 ml | Dietary Supplement | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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185 patients infected with a new coronavirus infection COVID-19 and getting respiratory support were enrolled to the study in accordance with the inclusion/exclusion criteria. Patients were randomly devided into two groups.
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail A Getman, Dr | Enrollme.ru | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City clinical hospital # 4 | Moscow | Russia | ||||
| Pirogov Medical university |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| Moscow |
| Russia |
| City clinical hospital # 11 | Omsk | Russia |
| City clinical hospital by Saint George the Great Martyr | Saint Petersburg | Russia |
| Pokrovskaya hospital | Saint Petersburg | Russia |
| Central city clinical hospital # 24 | Yekaterinburg | Russia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |