Phase III, Randomized, Double-blind, Placebo controlled trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients

Ramachandran, Ravishankar; Bhosale, Vivek; Reddy, Himanshu; Atam, Virendra; Faridi, M. M. A.; Fatima, Jalees; Shukla, Vaibhav; Khan, Zaw Ali; Khan, Huma; Singh, Vikram; Negi, Mahendra Pal Singh; Srivastava, Mukesh; Srivastava, Ajay Kumar; Tripathi, Chandra Bhushan; Ghosh, Nayan; Majumdar, Nilanjana; Tripathi, Raj Kamal; Rath, Srikanta Kumar; Mishra, Prabhat Ranjan; Sharma, Sharad; Kundu, Tapas K.

doi:10.1016/j.ijid.2021.11.025

Cited by 21 publications

(13 citation statements)

References 11 publications

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“…However, in CKD and immunocompromised patients, the use of umifenovir is not suitable ( Lian et al, 2020 ). A phase III trial suggested that umifenovir was efficacious in mild-asymptomatic COVID-19 patients when given at the dose of 800 mg twice a day for a maximum of 14 days ( Ramachandran et al, 2022 ). However, a multicenter retrospective revealed that umifenovir treatment is associated with increased in-hospital mortality ( Zhou et al, 2021 ).…”

Section: Antivirals For the Treatment Of Covid-19mentioning

confidence: 99%

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

et al. 2023

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Antiviral drugs such as Remdesivir (Veklury), Nirmatrelvir with Ritonavir (Paxlovid), Azvudine, and Molnupiravir (Lagevrio) can reduce the risk for severe and fatal Coronavirus Disease (COVID)-19. Although chronic kidney disease is a highly prevalent risk factor for severe and fatal COVID-19, most clinical trials with these drugs excluded patients with impaired kidney function. Advanced CKD is associated with a state of secondary immunodeficiency (SIDKD), which increases the susceptibility to severe COVID-19, COVID-19 complications, and the risk of hospitalization and mortality among COVID-19 patients. The risk to develop COVID-19 related acute kidney injury is higher in patients with precedent CKD. Selecting appropriate therapies for COVID-19 patients with impaired kidney function is a challenge for healthcare professionals. Here, we discuss the pharmacokinetics and pharmacodynamics of COVID-19-related antiviral drugs with a focus on their potential use and dosing in COVID-19 patients with different stages of CKD. Additionally, we describe the adverse effects and precautions to be taken into account when using these antivirals in COVID-19 patients with CKD. Lastly, we also discuss about the use of monoclonal antibodies in COVID-19 patients with kidney disease and related complications.

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Section: Antivirals For the Treatment Of Covid-19mentioning

confidence: 99%

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

et al. 2023

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“…Late last year, molnupiravir was also authorized by the FDA for the treatment of mild-to-moderate COVID-19 in adults. Alternate antiviral drugs such as Umifenovir (an anti-influenza drug that blocks viral entry mediated by endocytosis) exhibited statistically significant efficacy for mild/asymptomatic patients in a phase III clinical trial [ 132 ]. However more clinical studies are needed to evaluate the efficacy and safety of these antivirals.…”

Section: Therapeutics Against Sars-cov-2mentioning

confidence: 99%

COVID-19: A Comprehensive Review on Cardiovascular Alterations, Immunity, and Therapeutics in Older Adults

Rivera‐Torres

Girón

José

2023

JCM

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Here, we present a review focusing on three relevant issues related to COVID-19 and its impact in older adults (60 years and older). SARS-CoV-2 infection starts in the respiratory system, but the development of systemic diseases accompanied by severe clinical manifestations has also been reported, with cardiovascular and immune system dysfunction being the major ones. Additionally, the presence of comorbidities and aging represent major risk factors for the severity and poor prognosis of the disease. Since aging-associated decline has been largely related to immune and cardiovascular alterations, we sought to investigate the consequences and the underlying mechanisms of these pathologies to understand the severity of the illness in this population. Understanding the effects of COVID-19 on both systems should translate into comprehensive and improved medical care for elderly COVID-19 patients, preventing cardiovascular as well as immunological alterations in this population. Approved therapies that contribute to the improvement of symptoms and a reduction in mortality, as well as new therapies in development, constitute an approach to managing these disorders. Among them, we describe antivirals, cytokine antagonists, cytokine signaling pathway inhibitors, and vaccines.

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“…To combat against COVID‐19, there are extensive efforts to develop technologies, such as vaccines, small molecule drugs, monoclonal antibodies, nucleic acid drugs, interferon therapy and polypeptides 3 . In terms of mode of action, these drugs can be divided into the following categories 4 : (a) targeting the viral structural proteins to prevent the virus invasion, such as vaccines, 5 monoclonal antibodies, 6 and Umifenovir 7 etc; (b) aiming at the key proteins and enzymes of the virus to inhibit its replication, such as Favipiravir, 8 Oseltamivir, 9 Lopinavir/ritonavir 10 etc; (c) acting on virulence factors and promoting innate immunity of the host, such as SOCS1/3 antagonist 11 ; (d) targeting proteins or biological processes related to virus entry, such as plitidepsin, 12 fluvoxamine 13 . Antiviral efficacies of these drugs are not satisfying due to the rapid regeneration of new SARS‐CoV‐2 variants.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of Oral LL‐37 against the Omicron BA.5.1.3 variant of SARS‐COV‐2: A randomized trial

Zhao,

Zhang,

Zhao

et al. 2023

Journal of Medical Virology

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Recombinant LL‐37 Lactococcus lactis (Oral LL‐37) was designed to prevent progression of COVID‐19 by targeting virus envelope, however, effectiveness and safety of Oral LL‐37 in clinical application was unclear. A total of 238 adult inpatients, open‐labelled, randomized, placebo‐controlled, single‐center study was conducted to investigate the primary end points, including negative conversion time (NCT) of SARS‐CoV‐2 RNA and adverse events (AEs). As early as intervened on 6th day of case confirmed, Oral LL‐37 could significantly shorten NCT (LL‐37 9.80 ± 2.67 vs. placebo 14.04 ± 5.89, p < 0.01). For Oral LL‐37, as early as treated in 6 days, the adjusted hazard ratio (HR) for a primary event of nucleic acid negative outcome was 6.27‐fold higher than 7‐day‐later (HR: 6.276, 95% confidence interval [CI]: 3.631–10.848, p < 0.0001), and the adjusted HR of Oral LL‐37 within 6 days is higher than placebo (HR: 2.427 95% CI: 1.239–4.751, p = 0.0097). No severe AEs were observed during hospitalization and follow‐up investigation. This study shows that early intervention of Oral LL‐37 incredibly reduces NCT implying a potential for clearance of Omicron BA.5.1.3 without evident safety concerns.

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Phase III, Randomized, Double-blind, Placebo controlled trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients

Cited by 21 publications

References 11 publications

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

COVID-19: A Comprehensive Review on Cardiovascular Alterations, Immunity, and Therapeutics in Older Adults

Efficacy and safety of Oral LL‐37 against the Omicron BA.5.1.3 variant of SARS‐COV‐2: A randomized trial

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