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Completed

NCT Number: NCT05579028

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City clinical hospital # 4, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Quality of life score, part "Physical Health component" according to the SF-36 questionnaire

    Time frame: up to 4 weeks

    SF-36 questionnaire

  2. Quality of life score, part "Mental Health component" according to the SF-36 questionnaire

    Time frame: up to 4 weeks

    SF-36 questionnaire

  3. Quality of life score "Total Quality of Life" according to the SF-36 questionnaire

    Time frame: up to 4 weeks

    SF-36 questionnaire

  4. Change in handgrip (decanewton) strength between visits 3 and 1

    Time frame: between inclusion and discharge from hospital (about 2-3 weeks)

    Hand grip measured with hand dynamometer

Secondary outcomes

  1. Duration (days) of the patient stay under respiratory support or in the intensive care unit

    Time frame: during observation

    Medical record

  2. Total stay in the hospital (days)

    Time frame: during observation

    Medical record

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

    Time frame: during observation

    PCFS is not validated but usefull tool to measure patients' functional status https://erj.ersjournals.com/content/56/1/2001494

  4. Nutritional Impact Symptom (NIS) Check-list score

    Time frame: during observation

    check-list and scale developed for cachexia patients and published in https://link.springer.com/article/10.1007/s13539-012-0099-x

Sponsors and collaborators

Lead sponsor

Enrollme.ru, LLC

Network

Collaborators

  • Danone Nutricia

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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