Omega-3 Oil Use in COVID-19 Patients in Qatar

NCT04836052 | Unknown Phase 3 DMC

• 1 other identifier: MRC-04-20-1120
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 infection has been widely spread since December 2019 and causing many comorbidities and fatalities. The most common clinical presentation of COVID-19 patients admitted to ICUs is respiratory failure , hypoxia and acute lung injury. While new therapies and vaccines are urgently being investigated, they may take an inordinate time to get to right people. Omega-3-oil has been shown to have less proinflammatory mediators that may have immunomodulating, anti-inflammatory and antiviral effect. Two main fatty acids in omega-3-oil including eicosapentaenoic acid and docosahexaenoic acid have shown benefit in patients with ARDS as well. So, the investigators proposed a randomized controlled study to evaluate the effectiveness of omega-3-oil supplementation 2 gm PO/NGT/OGT twice daily for 28 days or till discharge or till death in COVID-19 critically ill patients admitted to ICU who require oxygen support.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• mechanical ventilator free days

  28 minus (days patient spent on ventilator if successfully liberated from ventilator)

  28 days

Secondary Outcomes (2)

• Change in oxygenation

  days 1, 3, 7

• Hospital Mortality

  28 days

Study Arms (2)

omega-3-oil arm

EXPERIMENTAL

patients admitted to ICU in HMC on any kind of oxygen support will get omega-3-oil 2 gm PO/NGT/OGT twice daily for 28 days or till ICU discharge or till death .

Drug: Omega 3 fatty acid

standard of care arm ( no omega -3-oil )

NO INTERVENTION

patients admitted to ICU in HMC on any kind of oxygen support will get ( standard of care= No Omega-3-oil ) but their labs will be monitored

Interventions

Omega 3 fatty acid DRUG

omega-3-oil 2 gm twice daily PO/NGT/OGT for 28 days or ICU discharge or death.

omega-3-oil arm

Eligibility Criteria

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

You may qualify if:

• adult ICU patients ≥18 years
• confirmed COVID-19 infection
• on-Oxygen support (mechanical ventilation, face masks, nasal cannula, etc.)
• Previous history of omega-3-oil with discontinuation of at least 1 month prior to admission

You may not qualify if:

• soya bean oil allergy
• fish allergy
• peanut allergy
• fish oil allergy
• pregnant women
• Continuous use of Omega-3-oil till admission

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, DC, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Fatty Acids, Omega-3

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)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Sandro Rizoli, PhD

CONTACT

+97444396157; srizoli@hamad.qa

AHMED ABDELBARI, Msc

CONTACT

+974-55810575; aabdelbari@hamad.qa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: April 8, 2021
• Study Start: December 24, 2020
• Primary Completion: August 24, 2021
• Study Completion: December 24, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-03

Locations

QA (1)