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

NCT06437210 | Completed

• 1 other identifier: VIUSID_POSTCOVID_CO_2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; Antioxidants; Post-COVID-19 Syndrome; Fatigue; Immunomodulator

Outcome Measures

Primary Outcomes (4)

• Evaluation of the symptoms associated with post-COVID-19 syndrome.

  Symptom assessment will be performed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes. In contrast to discrete, Likert-type scales, the VAS-F places fewer restrictions on the range of responses available to individuals. However, the benefi ts of a visual analogue scale may be offset by the frequent reluctance of individuals to use the highest and lowest extremes. Scoring Each line is 100 mm in length - thus, scores fall between 0 and 100. The instrument also possesses two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). Though individuals do not require training in order to score the scale, developers are quick to point out that high levels of inter-rater reliability are vital if results are to be correctly interpreted.

  30 days

• Evaluation of inflammation associated with Post-COVID-19 syndrome.

  Evaluation of inflammation associated with Post-COVID-19 syndrome by analysis of IL-6 in venous blood samples before and after treatment, compared to the placebo group. The values for IL-6 concentration in the blood of healthy donors varied between 0 and 43.5 pg/ml. IL-6 concentrations above 43.5 pg/ml will be taken as inflammation values.

  30 days

• Evaluation of oxidative stress associated with Post-COVID-19 syndrome

  Evaluation of oxidative stress associated with Post-COVID-19 syndrome by analysis of glutathione peroxidase concentration in venous blood samples before and after treatment, compared to the placebo group. Reference normal intervals range from 196 to 477 U/L in plasma, from 49 to 93 U/gHb in erythrocytes and from 52 to 96 U/gHb in whole blood.

  30 days

• Evaluation of pulmonar fibrosis associated with Post-COVID-19 syndrome

  To evaluate the effect of Viusid on the recovery of respiratory symptoms associated with Post-COVID-19 syndrome by thoracic CT imaging analysis before and after treatment and in comparison with the placebo group. For the CT assessment, image analysis will be performed through digital processing, where different grayscale image data will be extracted in order to obtain numerical information about the evident pulmonary fibrosis, taking into account the intensity of the targets in the region of interest (i.e. lung tissue), comparing it with control images of healthy lungs. In addition, radiomic analysis and segmentation of the affected areas will be applied to obtain quantitative data on the severity of fibrosis. In addition, the images of interest will be visually analyzed by the project's medical staff, so that fibrosis can be directly diagnosed.

  30 days

Study Arms (2)

Viusid Group

EXPERIMENTAL

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

Dietary Supplement: Viusid Oral Solution

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Viusid Oral Solution 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.

Viusid Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Fundación CR INVESTIGATION INSTITUTE

Bogotá, Bogotá DC, 110131, Colombia

Location

Related Publications (4)

• 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.

  PMID: 35264409 BACKGROUND

• 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.

  PMID: 32708578 BACKGROUND

• 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.

  PMID: 33692530 BACKGROUND

• 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.

  PMID: 17311621 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Viusid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: May 31, 2024
• Study Start: February 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: March 15, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CO (1)