Evaluation of Treatment With Viusid in Post-COVID-19 Syndrome

NCT ID: NCT06437210

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-03-15

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 and/or 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 lopinavir/ritonavir 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 body's 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 (0.033g), 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.

Conditions

Post-COVID-19 Syndrome; COVID-19; Dyspnea; Fatigue; Cough; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Viusid Group

Oral administration of viusid oral solution 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Group Type: EXPERIMENTAL

Viusid Oral Solution

Intervention Type: DIETARY_SUPPLEMENT

Patients in the experimental intervention group will be administered Viusid Oral Solution (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Placebo Group

Oral administration of placebo 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Patients in the experimental intervention group will be administered Placebo (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Interventions

Viusid Oral Solution

Patients in the experimental intervention group will be administered Viusid Oral Solution (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Patients in the experimental intervention group will be administered Placebo (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Patients with one or more of the following symptoms, persistent after suffering COVID-19:

• Extreme tiredness (Fatigue).
• Shortness of breath
• Chest pain
• Problems with memory or concentration ("Brain fog")
• Insomnia
• Palpitations
• Dizziness
• Tingling
• Joint pain
• Depression and anxiety
• Tinnitus or ear pain
• Malaise, diarrhea, stomach pain, loss of appetite
• Fever, cough, headache, dry throat, changes in sense of smell or taste
• Rash

Exclusion Criteria

• Patients with a positive diagnosis of COVID-19 in the last 14 days.
• Patients who have presented symptoms similar to Post-COVID syndrome prior to the onset of COVID-19 due to a concomitant disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundación CR INVESTIGATION INSTITUTE

Bogotá, Bogotá DC, Colombia

Countries

Colombia

References

Montani D, Savale L, Noel N, Meyrignac O, Colle R, Gasnier M, Corruble E, Beurnier A, Jutant EM, Pham T, Lecoq AL, Papon JF, Figueiredo S, Harrois A, Humbert M, Monnet X; COMEBAC Study Group. Post-acute COVID-19 syndrome. Eur Respir Rev. 2022 Mar 9;31(163):210185. doi: 10.1183/16000617.0185-2021. Print 2022 Mar 31.

Reference Type: BACKGROUND

PMID: 35264409 (View on PubMed)

Silvagno F, Vernone A, Pescarmona GP. The Role of Glutathione in Protecting against the Severe Inflammatory Response Triggered by COVID-19. Antioxidants (Basel). 2020 Jul 16;9(7):624. doi: 10.3390/antiox9070624.

Reference Type: BACKGROUND

PMID: 32708578 (View on PubMed)

Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.

Reference Type: BACKGROUND

PMID: 33692530 (View on PubMed)

Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.

Reference Type: BACKGROUND

PMID: 17311621 (View on PubMed)

Other Identifiers

VIUSID_POSTCOVID_CO_2022

Identifier Type: -

Identifier Source: org_study_id