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

NCT ID: NCT05579028

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-01

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Nutridrink ONS 200 ml

Intervention Type 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

Control

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

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danone Nutricia

INDUSTRY

Sponsor Role collaborator

Enrollme.ru, LLC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikhail A Getman, Dr

Role: STUDY_DIRECTOR

Enrollme.ru

Locations

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City clinical hospital # 4

Moscow, , Russia

Site Status

Pirogov Medical university

Moscow, , Russia

Site Status

City clinical hospital # 11

Omsk, , Russia

Site Status

City clinical hospital by Saint George the Great Martyr

Saint Petersburg, , Russia

Site Status

Pokrovskaya hospital

Saint Petersburg, , Russia

Site Status

Central city clinical hospital # 24

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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RECOVID

Identifier Type: -

Identifier Source: org_study_id

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