Lipid Emulsion Infusion and COVID-19 Patients

Assiut University

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Drug: SMOFlipid; Other: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04957940

17300631

Details and patient eligibility

About

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).

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

SMOF lipid 20% IV infusion

Experimental group

Description:

Intravenous fish-oil-based lipid (SMOF lipid 20%) emulsion supplementation to standard enteral nutrition.

Treatment:

Drug: SMOFlipid

Saline placebo IV infusion

Placebo Comparator group

Description:

Intravenous 0.9% saline supplementation to standard enteral nutrition.

Treatment:

Other: 0.9% saline