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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: Nutridrink ONS 200 ml

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation
    • Central city clinical hospital # 24
  • Moscow, Russian Federation
    • City clinical hospital # 4
  • Moscow, Russian Federation
    • Pirogov Medical university
  • Omsk, Russian Federation
    • City clinical hospital # 11
  • Saint Petersburg, Russian Federation
    • City clinical hospital by Saint George the Great Martyr
  • Saint Petersburg, Russian Federation
    • Pokrovskaya hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Dietary supplement: Nutridrink ONS 200 ml; 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
Control; Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Enrollme.ru, LLC
• Collaborators: Danone Nutricia
• Investigators: Study Director: Mikhail A Getman, Dr, Enrollme.ru

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; ICU; covid-19; physical recovery; respiratory support
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RECOVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No