Lipid Emulsion Infusion and COVID-19 Patients

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04957940
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 27.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: SMOFlipid; Other: 0.9% saline	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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?
• Actual Study Start Date: Jul 5, 2021
• Actual Primary Completion Date: Sep 20, 2021
• Actual Study Completion Date: Sep 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SMOF lipid 20% IV infusion Intravenous fish-oil-based lipid (SMOF lipid 20%) emulsion supplementation to standard enteral nutrition.	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.
Placebo Comparator: Saline placebo IV infusion Intravenous 0.9% saline supplementation to standard enteral nutrition.	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; Other Names: Normal saline

Outcome Measures

Primary Outcome Measures

1. Shift of patients to ICU [7 days]

   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

1. Percentage of short-term outcome [7 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university hospital	Assiut	Assuit	Egypt	Assuit universi

Sponsors and Collaborators

• Assiut University

Investigators

• Study Director: Omar Soliman, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Makram Soliman, Lecturer of anesthesia and ICU, Assiut University
• ClinicalTrials.gov Identifier: NCT04957940
• Other Study ID Numbers: 17300631
• First Posted: Jul 12, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; SMOFlipid

Study Results

No Results Posted as of Sep 28, 2021