Lipid Emulsion Infusion and COVID-19 Patients

Covid19 Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957940
• Other study ID #: 17300631
• Status: Completed
• Phase: Phase 3
• Start date: July 5, 2021
• Est. completion date: September 26, 2021

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 26, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• SMOFlipid
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.

Other:
• 0.9% saline
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

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Simopoulos AP. Omega-3 fatty acids in inflammation and autoimmune diseases. J Am Coll Nutr. 2002 Dec;21(6):495-505. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	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.	7 days