COVID-19NCT05579028
Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support
An observational study of COVID-19, run by Enrollme.ru, LLC at 6 sites in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Nutridrink ONS 200 ml
- How many people
- 185 participants
- Where
- 6 sitesRussia
- Study dates
- 1 Jun 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Diabetes mellitus;
- Renal failure;
- Hepatic failure;
- Systemic disease;
- Active cancer;
- Poor survival prognosis.
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
City clinical hospital # 4
Moscow
Pirogov Medical university
Moscow
City clinical hospital # 11
Omsk
City clinical hospital by Saint George the Great Martyr
Saint Petersburg
Pokrovskaya hospital
Saint Petersburg
Central city clinical hospital # 24
Yekaterinburg
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Nutridrink ONS 200 ml
- Keywords
- covid-19, ICU, respiratory support, quality of life, physical recovery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutridrink ONS 200 mlDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Nutridrink ONS 200 ml | |
| Control | Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score, part "Physical Health component" according to the SF-36 questionnaire
SF-36 questionnaire
Measured: up to 4 weeks
Quality of life score, part "Mental Health component" according to the SF-36 questionnaire
SF-36 questionnaire
Measured: up to 4 weeks
Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
SF-36 questionnaire
Measured: up to 4 weeks
Change in handgrip (decanewton) strength between visits 3 and 1
Hand grip measured with hand dynamometer
Measured: between inclusion and discharge from hospital (about 2-3 weeks)
Secondary outcomes (4)
Duration (days) of the patient stay under respiratory support or in the intensive care unit
Medical record
Measured: during observation
Total stay in the hospital (days)
Medical record
Measured: during observation
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
Measured: during observation
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
Measured: during observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrollme.ru, LLC
- Sponsor type
- Research network
- Collaborators
- Danone Nutricia
- Responsible party
- Sponsor
- Investigators
- Mikhail A Getman, Dr, Study director, Enrollme.ru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579028
- Sponsor's protocol ID
- RECOVID
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05579028
- Acronym / sponsor ID
- RECOVID
- Conditions
- COVID-19
- Keywords
- covid-19, ICU, respiratory support, quality of life, physical recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Enrollme.ru, LLCResearch network
- Collaborators
- Danone Nutricia
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Dietary Supplement: Nutridrink ONS 200 mlPatients 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. |
| Control | – | –Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Diabetes mellitus;
- Renal failure;
- Hepatic failure;
- Systemic disease;
- Active cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutridrink ONS 200 mlNutridrink 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 | Dietary supplement | Study |
Primary outcome
Quality of life score, part "Physical Health component" according to the SF-36 questionnaire
Time frame: up to 4 weeks
SF-36 questionnaire
Quality of life score, part "Mental Health component" according to the SF-36 questionnaire
Time frame: up to 4 weeks
SF-36 questionnaire
Quality of life score "Total Quality of Life" according to the SF-36 questionnaire
Time frame: up to 4 weeks
SF-36 questionnaire
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
4 secondary outcomes
Duration (days) of the patient stay under respiratory support or in the intensive care unit
Time frame: during observation
Total stay in the hospital (days)
Time frame: during observation
Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale
Time frame: during observation
Nutritional Impact Symptom (NIS) Check-list score
Time frame: during observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail A Getman, Dr study director
Enrollme.ru
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Enrollme.ru, LLC at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score, part "Physical Health component" according to the SF-36 questionnaire (time frame: up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.