An observational study in COVID-19, sponsored by Enrollme.ru, LLC. Completed at 6 sites in Russian Federation. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Enrollme.ru, LLC · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 185 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Enrollme.ru, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
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
Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet.
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
Quality of life score, part "Physical Health component" according to the SF-36 questionnaire
SF-36 questionnaire
Time frame: up to 4 weeks
Quality of life score, part "Mental Health component" according to the SF-36 questionnaire
SF-36 questionnaire
Time frame: up to 4 weeks
Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
SF-36 questionnaire
Time frame: up to 4 weeks
Change in handgrip (decanewton) strength between visits 3 and 1
Hand grip measured with hand dynamometer
Time frame: between inclusion and discharge from hospital (about 2-3 weeks)
Duration (days) of the patient stay under respiratory support or in the intensive care unit
Medical record
Time frame: during observation
Total stay in the hospital (days)
Medical record
Time frame: 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
Time frame: 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
Time frame: during observation
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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