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

Enrollme.ru

Status: Completed

Conditions: COVID-19

Treatments: Dietary Supplement: Nutridrink ONS 200 ml

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05579028

RECOVID

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

185 participants in 2 patient groups

Study

Description:

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.

Treatment:

Dietary Supplement: Nutridrink ONS 200 ml

Control

Description:

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