Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437210
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-30
Brief Title:
Evaluation of Treatment With Viusid in Post-COVID-19 Syndrome
Sponsor:
Catalysis SL
Organization:
Catalysis SL
Study Overview
Official Title:
Evaluation of Treatment With Viusid in Post-COVID-19 Syndrome
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reports of long-lasting symptoms of COVID-19 are increasing but little is known about the prevalence of risk factors or whether it is possible to predict a prolonged course at disease onset Prolonged COVID is characterized on the basis of symptoms such as fatigue headache dyspnea and anosmia present for weeks with older age high body mass index and female sex being more susceptible
Accordingly and in the absence of specific treatments the present study seeks to establish a treatment protocol for Post-COVID syndrome through the application of the dietary supplement VIUSID due to its anti-inflammatory and immunomodulatory effect thus helping to reduce andor control the symptoms of the syndrome
Accordingly and in the absence of specific treatments the present study seeks to establish a treatment protocol for Post-COVID syndrome through the application of the dietary supplement VIUSID due to its anti-inflammatory and immunomodulatory effect thus helping to reduce andor control the symptoms of the syndrome
Detailed Description:
Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2e is the pathogen responsible for the 2019 coronavirus disease pandemic COVID-19 which has caused global health care crises and overstretched health care resources Scientific and clinical evidence is evolving on the subacute and long-term effects of COVID-19 which can affect multiple organ systems As the population of patients recovering from COVID-19 grows it is critical to establish an understanding of the healthcare issues surrounding them COVID-19 is now recognized as a multi-organ disease with a broad spectrum of manifestations
Early reports suggest residual effects of SARS-CoV-2c infection such as fatigue dyspnea chest pain cognitive impairment arthralgia and impaired quality of life Cellular damage a robust innate immune response with inflammatory cytokine production and a procoagulant state induced by SARS-CoV-2 infection may contribute to these sequelae Survivors of previous coronavirus infections including the 2003 SARS epidemic and the 2012 Middle East Respiratory Syndrome MERS outbreak have demonstrated a similar set of persistent symptoms reinforcing concerns about clinically significant sequelae of COVID-19
Some countries use several drugs to treat coronavirus In one of its documents the Spanish Society of Medicine mentions the recommendations of the protocol developed for the treatment of COVID-19 Specific antiviral treatment requires drugs such as lopinavirritonavir administered orally This drug is indicated to help control human immunodeficiency virus HIV infection It is only administered orally 0 in concomitant treatment with interferon beta-lb In this case Betaferon is recommended which is indicated for the treatment of multiple sclerosis Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections Lopinavir ritonavir can also be used in combination with an alpha-2B interferon such as Intron A which modifies the immune system response of the patient the bodys immune system to help fight infections and serious illnesses
Viusid Catalysis Laboratories Madrid Spain is a nutritional supplement with recognized antioxidant and immunomodulatory properties that have beneficial effects on clinical outcomes related to cirrhosis such as survival disease progression and the development of hepatocellular carcinoma HCC It contains different molecules ascorbic acid zinc and glycyrrhizic acid with recognized antioxidant and immunomodulatory properties Glycyrrhizin 0033g the most important active ingredient of the supplement is known to have an immunomodulatory antiviral and biological effect and has also demonstrated various anti-inflammatory properties such as increased production of IL-10 a potent anti-inflammatory cytokine that inhibits the synthesis of many proinflammatory proteins as well as an anti-apoptotic effect hepatocyte proliferation and stabilization of cell membranes in the liver Recent data suggest that Viusid ameliorates oxidative stress through the reduction of 105 lipid peroxidation products and that it has an immunomodulatory effect on cytokine secretion through increased cytokine secretion by the liver cytokines through increased production of IFN-y and IL-l0 decreased production of IL-ly stabilized tumor necrosis factor and secretion in HCV patients who have failed previous antiviral treatments
Taking into account the benefits of Viusid such as the reduction of inflammation and the immunomodulatory effect a randomized double-blind study is proposed to evaluate the treatment with this food supplement in 200 patients with post-COVID syndrome diagnosed assessing the improvement of their symptoms before and after treatment for 1 month through clinical and paraclfnical examinations
Early reports suggest residual effects of SARS-CoV-2c infection such as fatigue dyspnea chest pain cognitive impairment arthralgia and impaired quality of life Cellular damage a robust innate immune response with inflammatory cytokine production and a procoagulant state induced by SARS-CoV-2 infection may contribute to these sequelae Survivors of previous coronavirus infections including the 2003 SARS epidemic and the 2012 Middle East Respiratory Syndrome MERS outbreak have demonstrated a similar set of persistent symptoms reinforcing concerns about clinically significant sequelae of COVID-19
Some countries use several drugs to treat coronavirus In one of its documents the Spanish Society of Medicine mentions the recommendations of the protocol developed for the treatment of COVID-19 Specific antiviral treatment requires drugs such as lopinavirritonavir administered orally This drug is indicated to help control human immunodeficiency virus HIV infection It is only administered orally 0 in concomitant treatment with interferon beta-lb In this case Betaferon is recommended which is indicated for the treatment of multiple sclerosis Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections Lopinavir ritonavir can also be used in combination with an alpha-2B interferon such as Intron A which modifies the immune system response of the patient the bodys immune system to help fight infections and serious illnesses
Viusid Catalysis Laboratories Madrid Spain is a nutritional supplement with recognized antioxidant and immunomodulatory properties that have beneficial effects on clinical outcomes related to cirrhosis such as survival disease progression and the development of hepatocellular carcinoma HCC It contains different molecules ascorbic acid zinc and glycyrrhizic acid with recognized antioxidant and immunomodulatory properties Glycyrrhizin 0033g the most important active ingredient of the supplement is known to have an immunomodulatory antiviral and biological effect and has also demonstrated various anti-inflammatory properties such as increased production of IL-10 a potent anti-inflammatory cytokine that inhibits the synthesis of many proinflammatory proteins as well as an anti-apoptotic effect hepatocyte proliferation and stabilization of cell membranes in the liver Recent data suggest that Viusid ameliorates oxidative stress through the reduction of 105 lipid peroxidation products and that it has an immunomodulatory effect on cytokine secretion through increased cytokine secretion by the liver cytokines through increased production of IFN-y and IL-l0 decreased production of IL-ly stabilized tumor necrosis factor and secretion in HCV patients who have failed previous antiviral treatments
Taking into account the benefits of Viusid such as the reduction of inflammation and the immunomodulatory effect a randomized double-blind study is proposed to evaluate the treatment with this food supplement in 200 patients with post-COVID syndrome diagnosed assessing the improvement of their symptoms before and after treatment for 1 month through clinical and paraclfnical examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None