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All Studies   Meta Analysis    Recent:   

Peg-interferon Lambda Single Dose Treatment for COVID-19: A Call to Avoid another Hydroxychloroquine Fiasco

Kelleni, M., Center for Open Science, doi:10.31219/osf.io/5xd6q
Mar 2023  
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Review of critical issues with Reis. Author notes that NEJM declined to publish these issues without comment.
Kelleni et al., 16 Mar 2023, preprint, 1 author. Contact: drthabetpharm@yahoo.com, mina.kelleni@mu.edu.eg.
This PaperPeg.. LambdaAll
Peg-interferon Lambda Single Dose Treatment for COVID-19: A Call to Avoid another
Hydroxychloroquine Fiasco, T Mina, MD Kelleni
In this perspective the author counter-argues a claim that was recently made that a single dose of Peg-interferon lambda can significantly lower incidence of COVID-19 hospitalizations or emergency department. The author discusses the flaws in a recently published article that suggested this benefit while asking the global authorities to learn from the prior mistakes and to be of utmost caution when considering its decision regarding adoption of a single dose of Peginterferon lambda to manage COVID-19.
subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care and followed for 28 days, the results showed no difference in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo (NCT04331899) as declared by the company on 28 September 2020. However, few days later, on 15 October 2020, the company cherished the results of 60 Canadian patients who were randomized 1:1 to a single subcutaneous dose of Lambda 180 mcg or normal saline placebo and were followed for 14 days, to be noted that when this trial (NCT04354259), called ILIAD, was published at The Lancet Respiratory Medicine, we found the founder of Eiger BioPharmaceuticals as well as other employees among its authors and the principal investigator declares receiving "research support unrelated to this work from Eiger BioPharmaceuticals" [9] . Taken together, I would like to express my rare support to the recent decision made by the American FDA to dismiss a request made by a pharmaceutical company to obtain an EUA for its pegylated interferon lambda to be used, as described in that clinical trial, for patients suffering from COVID-19. Furthermore, I wish to call for a very cautious re-analysis of all the results mentioned in the discussed clinical trial including the reported serious adverse effects. Finally, I wish to confirm the wisdom of a brilliant published observation, though I disagree with its authors regarding the interpretations leading..
References
Feld, Kandel, Biondi, Kozak, Zahoor et al., Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial, The Lancet Respiratory Medicine
Kelleni, COVID-19, Ebola virus disease, and Nipah virus infection reclassification as novel acute immune dysrhythmia syndrome (n-AIDS): potential crucial role for immunomodulators, Immunol Res
Kelleni, Evolution of SARS CoV-2 Omicron Subvariants BF.7 and XBB.1.5: Time to follow Africa and abort all COVID Restrictions, J Infect
Kelleni, NSAIDs and Kelleni's protocol as potential early COVID-19 treatment game changer: could it be the final countdown?, Inflammopharmacology
Kelleni, NSAIDs/nitazoxanide/azithromycin repurposed for COVID-19: potential mitigation of the cytokine storm interleukin-6 amplifier via immunomodulatory effects, Expert Rev Anti Infect Ther
Kelleni, Nitazoxanide/azithromycin combination for COVID-19: A suggested new protocol for early management, Pharmacol Res
Kelleni, Real-life practice of the Egyptian Kelleni's protocol in the current tripledemic: COVID-19, RSV and influenza, J Infect
Kelleni, Tocilizumab, Remdesivir, Favipiravir, and Dexamethasone Repurposed for COVID-19: a Comprehensive Clinical and Pharmacovigilant Reassessment, SN Compr Clin Med
Mangin, Howard, The use of inhaled corticosteroids in early-stage COVID-19, The Lancet
Reis, Silva, Silva, Thabane, Campos et al., Early Treatment with Pegylated Interferon Lambda for Covid-19, New England Journal of Medicine
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