Lipid Emulsion Infusion and COVID-19 Patients

NCT04957940 | Completed Phase 3 DMC

• 1 other identifier: 17300631
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of short-term outcome

  7 days

Study Arms (2)

SMOF lipid 20% IV infusion

EXPERIMENTAL

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

Drug: SMOFlipid

Saline placebo IV infusion

PLACEBO COMPARATOR

Intravenous 0.9% saline supplementation to standard enteral nutrition.

Other: 0.9% saline

Interventions

SMOFlipid DRUG

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.

SMOF lipid 20% IV infusion

0.9% saline OTHER

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

Also known as: Normal saline

Saline placebo IV infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location

Related Publications (1)

• 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.

  PMID: 12480795 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

SMOFlipid; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Omar Soliman, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: July 5, 2021
• Primary Completion: September 20, 2021
• Study Completion: September 26, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

EG (1)