Back to resultsLipid Emulsion Infusion and COVID-19 Patients
Primary Purpose
Covid19
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
SMOFlipid
0.9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. However, their blood oxygen levels remain ≥94%)
- Requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our ICU with good enteral nutrition.
Exclusion Criteria:
- Hypersensitivity (peanut,eggs and soya bean)
- Uncontrolled hyperlipidemia
- Severe primary blood coagulation diseases
- Acute pancreatitis
- Acute thromboembolic diseases
- Liver failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate aminotransferase >100 U/l)
- RIFLE (Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease) stage III and IV renal failure
- Pregnancy or lactation
- Severe neutropenia (<500 cells/mm3)
Sites / Locations
- Assiut university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SMOF lipid 20% IV infusion
Saline placebo IV infusion
Arm Description
Intravenous fish-oil-based lipid (SMOF lipid 20%) emulsion supplementation to standard enteral nutrition.
Intravenous 0.9% saline supplementation to standard enteral nutrition.
Outcomes
Primary Outcome Measures
Shift of patients to ICU
Patients will be shifted to ICU for upgrading oxygenation &/or ventilation due to failed management in the intermediate care attached to our ICU (simple nasal cannula or venturi mask oxygen).According to the Chinese diagnosis and treatment guideline for COVID-19 (trial version 7.0), severe cases were defined as including one of the following criteria: (1) respiratory frequency >30/min, (2) oxygen saturation ≤93%, and (3) PO2/FiO2 ≤300 (taking consideration that severe ARDS PO2/FiO2 ratio < 100). Severe patients who need higher levels of oxygen support (high-flow nasal cannula HFNC or non invasive continuous positive airway pressure CPAP) to correct hypoxemia, or multiple organ dysfunction, are admitted to the ICU.
Secondary Outcome Measures
Percentage of short-term outcome
Assessing the percentage % of short-term outcome for cases admitted in the intermediate care attached to our ICU and numbers of patients either died, shifted to ICU for upgrading oxygenation and or ventilation or discharged to home.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04957940
Brief Title
Lipid Emulsion Infusion and COVID-19 Patients
Official Title
Fish-Oil-Based Lipid Emulsion Infusion (FOBLE): Could Early Use Provide a Potential Therapy to Stop Moderate Cases of COVID-19 Diseased Patient's Shift to ICU?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators suggest that early administration of intravenous lipid emulsion (ILE) affect the inflammatory response and improve outcome in COVID-19. The aim of this trial is to study the effect of fish-oil-based intravenous lipid emulsion (FOBLE) supplementation added to enteral nutrition on shift to ICU for upgrading oxygenation &/or ventilation in moderate cases of Covid-19 diseased patients requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen (during 7 days admission).
Detailed Description
A written informed consent will be taken from the patients or their relatives. Patients will be randomly assigned to receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days as the control group (Group C) or intravenous fish-oil-based lipid (SMOF lipid 20% which contains a unique 4-oil mix containing Soya bean, Medium-chain triglycerides, Olive oil and Fish oil) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition (group L) in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.Finally, 20 mL of 0.9% normal saline was injected into the burette to flush the system. The entire apparatus was disposed of when each infusion was completed. The whole process was repeated for each infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMOF lipid 20% IV infusion
Arm Type
Experimental
Arm Description
Intravenous fish-oil-based lipid (SMOF lipid 20%) emulsion supplementation to standard enteral nutrition.
Arm Title
Saline placebo IV infusion
Arm Type
Placebo Comparator
Arm Description
Intravenous 0.9% saline supplementation to standard enteral nutrition.
Intervention Type
Drug
Intervention Name(s)
SMOFlipid
Intervention Description
Intravenous fish-oil-based lipid (SMOF lipid 20%) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.
Intervention Type
Other
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
Normal saline
Intervention Description
Receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days
Primary Outcome Measure Information:
Title
Shift of patients to ICU
Description
Patients will be shifted to ICU for upgrading oxygenation &/or ventilation due to failed management in the intermediate care attached to our ICU (simple nasal cannula or venturi mask oxygen).According to the Chinese diagnosis and treatment guideline for COVID-19 (trial version 7.0), severe cases were defined as including one of the following criteria: (1) respiratory frequency >30/min, (2) oxygen saturation ≤93%, and (3) PO2/FiO2 ≤300 (taking consideration that severe ARDS PO2/FiO2 ratio < 100). Severe patients who need higher levels of oxygen support (high-flow nasal cannula HFNC or non invasive continuous positive airway pressure CPAP) to correct hypoxemia, or multiple organ dysfunction, are admitted to the ICU.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Percentage of short-term outcome
Description
Assessing the percentage % of short-term outcome for cases admitted in the intermediate care attached to our ICU and numbers of patients either died, shifted to ICU for upgrading oxygenation and or ventilation or discharged to home.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. However, their blood oxygen levels remain ≥94%)
Requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our ICU with good enteral nutrition.
Exclusion Criteria:
Hypersensitivity (peanut,eggs and soya bean)
Uncontrolled hyperlipidemia
Severe primary blood coagulation diseases
Acute pancreatitis
Acute thromboembolic diseases
Liver failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate aminotransferase >100 U/l)
RIFLE (Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease) stage III and IV renal failure
Pregnancy or lactation
Severe neutropenia (<500 cells/mm3)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12480795
Citation
Simopoulos AP. Omega-3 fatty acids in inflammation and autoimmune diseases. J Am Coll Nutr. 2002 Dec;21(6):495-505. doi: 10.1080/07315724.2002.10719248.
Results Reference
result
Learn more about this trial
Lipid Emulsion Infusion and COVID-19 Patients
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