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

COVID-19 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579028
• Other study ID #: RECOVID
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2022
• Source: Enrollme.ru, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Enrollme.ru, LLC	Danone Nutricia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life score, part "Physical Health component" according to the SF-36 questionnaire	SF-36 questionnaire	up to 4 weeks
Primary	Quality of life score, part "Mental Health component" according to the SF-36 questionnaire	SF-36 questionnaire	up to 4 weeks
Primary	Quality of life score "Total Quality of Life" according to the SF-36 questionnaire	SF-36 questionnaire	up to 4 weeks
Primary	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	Duration (days) of the patient stay under respiratory support or in the intensive care unit	Medical record	during observation
Secondary	Total stay in the hospital (days)	Medical record	during observation
Secondary	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
Secondary	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