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

NCT05579028 | Completed

• 1 other identifier: RECOVID
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

COVID-19

Keywords

covid-19; ICU; respiratory support; quality of life; physical recovery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

• Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale

  during observation

• Nutritional Impact Symptom (NIS) Check-list score

  during observation

Study Arms (2)

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

Control

Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet.

Interventions

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

Study

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enrollme.ru, LLC: lead
• Danone Nutricia: collaborator

Study Sites (6)

City clinical hospital # 4

Moscow, Russia

Location

Pirogov Medical university

Moscow, Russia

Location

City clinical hospital # 11

Omsk, Russia

Location

City clinical hospital by Saint George the Great Martyr

Saint Petersburg, Russia

Location

Pokrovskaya hospital

Saint Petersburg, Russia

Location

Central city clinical hospital # 24

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mikhail A Getman, Dr

  Enrollme.ru

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 13, 2022
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

RU (6)