Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:18 PM
Study NCT ID:
NCT05579028
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life score, part "Physical Health component" according to the SF-36 questionnaire', 'timeFrame': 'up to 4 weeks', 'description': 'SF-36 questionnaire'}, {'measure': 'Quality of life score, part "Mental Health component" according to the SF-36 questionnaire', 'timeFrame': 'up to 4 weeks', 'description': 'SF-36 questionnaire'}, {'measure': 'Quality of life score "Total Quality of Life" according to the SF-36 questionnaire', 'timeFrame': 'up to 4 weeks', 'description': 'SF-36 questionnaire'}, {'measure': 'Change in handgrip (decanewton) strength between visits 3 and 1', 'timeFrame': 'between inclusion and discharge from hospital (about 2-3 weeks)', 'description': 'Hand grip measured with hand dynamometer'}], 'secondaryOutcomes': [{'measure': 'Duration (days) of the patient stay under respiratory support or in the intensive care unit', 'timeFrame': 'during observation', 'description': 'Medical record'}, {'measure': 'Total stay in the hospital (days)', 'timeFrame': 'during observation', 'description': 'Medical record'}, {'measure': 'Severity of the current status according to the Post-COVID19 Functional Status (PCFS) Scale', 'timeFrame': 'during observation', 'description': "PCFS is not validated but usefull tool to measure patients' functional status https://erj.ersjournals.com/content/56/1/2001494"}, {'measure': 'Nutritional Impact Symptom (NIS) Check-list score', 'timeFrame': 'during observation', 'description': 'check-list and scale developed for cachexia patients and published in https://link.springer.com/article/10.1007/s13539-012-0099-x'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'ICU', 'respiratory support', 'quality of life', 'physical recovery'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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:\n\n* if additional nutrition support has an effect on recovery of physical health in patients with COVID-19;\n* to examine the effect of additional nutrition support on quality of life of patients with COVID-19;\n* to examine the effect of the additional nutrition support on hospitalization period of patients with COVID-19.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed new coronavirus infection COVID-19 (based on laboratory and/or computer tomography data);\n* Need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position);\n* 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);\n* The informed consent is signed by a patient for the study enrollment and processing of personal data.\n\nExclusion Criteria:\n\n* Diabetes mellitus;\n* Renal failure;\n* Hepatic failure;\n* Systemic disease;\n* Active cancer;\n* Poor survival prognosis.\n* Aggravation of a patient\'s condition requiring his transfer to enteral feeding and/or parenteral nutrition;\n* Occurrence of complications requiring surgical interventions;\n* Patient\'s transfer for treatment to another inpatient unit;\n* Complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting);\n* Withdrawal of the informed consent for the study enrollment and processing of personal data.'}, 'identificationModule': {'nctId': 'NCT05579028', 'briefTitle': 'Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support', 'organization': {'class': 'NETWORK', 'fullName': 'Enrollme.ru, LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RECOVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study', 'description': "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.", 'interventionNames': ['Dietary Supplement: Nutridrink ONS 200 ml']}, {'label': 'Control', 'description': 'Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet.'}], 'interventions': [{'name': 'Nutridrink ONS 200 ml', 'type': 'DIETARY_SUPPLEMENT', 'description': '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', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'City clinical hospital # 4', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Pirogov Medical university', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Omsk', 'country': 'Russia', 'facility': 'City clinical hospital # 11', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City clinical hospital by Saint George the Great Martyr', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pokrovskaya hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Central city clinical hospital # 24', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Mikhail A Getman, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Enrollme.ru'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enrollme.ru, LLC', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Danone Nutricia', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}