Immunomodulation by intravenous omega‐3 fatty acid treatment in older subjects hospitalized for COVID‐19: A single‐blind randomized controlled trial
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SciScore for 10.1101/2021.12.27.21268264: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: After signed informed consent, participants were randomized 1:1 to a once daily i.v. infusion (2 mL/kg) of either placebo (0.9% NaCl) or n-3 PUFA emulsion (Omegaven® bought from ApoEX, Stockholm, Sweden) containing 10 g of fish oil per 100 mL, of which 1.25-2.82 g DHA and 1.44-3.09 g EPA for 5 days.
Field Sample Permit: Blood cell isolation: Whole blood was collected into an 8 mL sodium heparinized CPT vacutainer and processed within 2 h of collection.Sex as a biological variable not detected. Randomization After signed informed consent, participants were randomized 1:1 to a once daily i.v. infusion (2 mL/kg) of either placebo (0.9% NaCl) or n-3 PUFA emulsion (Omegaven® bought from … SciScore for 10.1101/2021.12.27.21268264: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: After signed informed consent, participants were randomized 1:1 to a once daily i.v. infusion (2 mL/kg) of either placebo (0.9% NaCl) or n-3 PUFA emulsion (Omegaven® bought from ApoEX, Stockholm, Sweden) containing 10 g of fish oil per 100 mL, of which 1.25-2.82 g DHA and 1.44-3.09 g EPA for 5 days.
Field Sample Permit: Blood cell isolation: Whole blood was collected into an 8 mL sodium heparinized CPT vacutainer and processed within 2 h of collection.Sex as a biological variable not detected. Randomization After signed informed consent, participants were randomized 1:1 to a once daily i.v. infusion (2 mL/kg) of either placebo (0.9% NaCl) or n-3 PUFA emulsion (Omegaven® bought from ApoEX, Stockholm, Sweden) containing 10 g of fish oil per 100 mL, of which 1.25-2.82 g DHA and 1.44-3.09 g EPA for 5 days. Blinding Participants were blinded to the intervention. Power Analysis Due to the limited statistical power of the study, descriptive outcomes were not tested for significance as defined in the prespecified analysis plan in the study protocol, which is provided as an Appendix online. Table 2: Resources
Antibodies Sentences Resources Samples were then incubated with APC-conjugated anti-human CD66b antibody, FITC-conjugated anti-human CD14 antibody, and eFluor450-conjugated anti-human CD45 antibody (all from Thermo Fisher Scientific, Waltham, MA, USA) for 15 min on ice. anti-human CD45suggested: NoneSamples were then incubated with APC-conjugated anti-human CD66b antibody, PE-conjugated anti-human CD41a antibody, FITC-conjugated anti-human CD14 antibody, and eFluor450-conjugated anti-human CD16 antibody (all from Thermo Fisher Scientific, Waltham, MA, USA) for 15 min at RT. anti-human CD16suggested: NoneSoftware and Algorithms Sentences Resources Cells were analyzed with BD Fortessa flow cytometer (BD Biosciences) and Flow Jo software version v10.7.0. Flow Josuggested: (FlowJo, RRID:SCR_008520)URL https://www.R-project.org/), Bioconductor version 3.13 (15), GraphPad (version 8.4.3, Sand Diego, California, USA), and SigmaPlot for Windows Version 14.5. Bioconductorsuggested: (Bioconductor, RRID:SCR_006442)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)SigmaPlotsuggested: (SigmaPlot, RRID:SCR_003210)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The main limitation is the low number of participants. It is important to consider that the study was a proof-of-concept trial powered to detect significant effects on leukocyte, lipid, and protein inflammatory biomarkers and designed to allow mechanistic exploration of n-3 PUFA metabolism and cellular effects (12). Larger studies are nevertheless needed to determine if the significantly improved NLR by n-3 PUFA translates into better clinical outcomes in COVID-19. The clinical outcomes were not statistically tested in the present trial according to the a priori study plan and were therefore only presented in descriptive analyses. The generalisability of identified lipid metabolites was not established in the present study. The trial was performed during the introduction of cortisone, which may have influenced the cytokine-release to prevent detecting n-3 PUFA-induced effects. The subgroups of n-3 PUFA and placebo groups with or without cortisone are small and were used only for the exploratory mechanistic experiments. The older study population with multiple comorbidities and moderate COVID-19 may limit the extrapolation of the results to younger patients and severe COVID-19 cases. In summary, the primary outcome indicated a beneficial cellular immune response by i.v. n-3 PUFA treatment of COVID-19 detected as lowered NLR. The significantly altered the plasma PUFA metabolite profiles with increased proresolving mediator precursor levels and decreased leukotoxin-diols support...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04647604 Recruiting Resolving Inflammatory Storm in COVID-19 Patients by Omega-3… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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