Clinical trial NCT05579028: Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: covid-19
ICU
respiratory support
quality of life
physical recovery
Lead sponsor: Enrollme.ru, LLC
Sponsor class: NETWORK
Collaborators: name: Danone Nutricia
First posted: 2022-10-13
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life score, part "Physical Health component" according to the SF-36 questionnaire
timeFrame: up to 4 weeks
measure: Quality of life score, part "Mental Health component" according to the SF-36 questionnaire
timeFrame: up to 4 weeks
measure: Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
timeFrame: up to 4 weeks
measure: Change in handgrip (decanewton) strength between visits 3 and 1
timeFrame: between inclusion and discharge from hospital (about 2-3 weeks)
Secondary outcomes:
measure: Duration (days) of the patient stay under respiratory support or in the intensive care unit
timeFrame: during observation
measure: Total stay in the hospital (days)
timeFrame: during observation
measure: Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale
timeFrame: during observation
measure: Nutritional Impact Symptom (NIS) Check-list score
timeFrame: during observation
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Central city clinical hospital # 24
city: Moscow
country: Russian Federation
facility: City clinical hospital # 4
city: Moscow
country: Russian Federation
facility: Pirogov Medical university
city: Omsk
country: Russian Federation
facility: City clinical hospital # 11
city: Saint Petersburg
country: Russian Federation
facility: City clinical hospital by Saint George the Great Martyr
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya hospital
Study officials:
affiliation: Enrollme.ru
name: Mikhail A Getman, Dr
role: STUDY_DIRECTOR
References: