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Covid19NCT04980534

Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip

A study testing Viusid and Asbrip and COVID-19 Standard Therapy in people with Covid19 and COVID-19 Pneumonia, run by Catalysis SL at 3 sites in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Viusid and Asbrip and COVID-19 Standard Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesKazakhstan
Study dates
8 Jan 2021to 15 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The eligibility criteria for inclusion in the study were as follows:

  • Male and female hospitalized patients who have signed an informed consent.
  • Aged between 18-85 years old.
  • RT-PCR confirmed COVID-19.
  • Fever (over 37.2 Celsius degrees).
  • CT scan percentage area of lung involvement with ground-glass opacities < 50 %.
  • Respiratory rate < 20-30 /min
  • SpO2 ≥ 95%.

The exclusion criteria were as follows:

  • Oxygen support (ventilation and non-invasive)
  • Uncompensated or exacerbated concomitant diseases or conditions that may complicate or make the patient's participation in the study impossible, or make it difficult to explain clinical findings.
  • Any known intolerability to any of the study regimens' components.
  • Patient's family or official relations with a member of staff of the clinical site.
  • Patient's failure to assess his/her physical and/or emotional condition.
  • Patient's failure to comply with the study requirements.
  • Patient's refusal to participate in the study.
  • Pregnancy or breastfeeding.

Trial locations and contacts

3 sites in 1 country.

Kazakhstan3 sites

  • City center for infectious diseases

    Astana, Astana, 010000

  • City children hospital №1

    Astana, Astana, 020000

  • JSC "Astana Medical University

    Astana, 010000

Other trials in Kazakhstan

About this study

This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.

Read the detailed description

This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.

A total of 80 subjects will be randomized 2:1 in this study. 50 patients will be assigned to receive daily oral doses of 4,5 g of Viusid every 12 hours and 10 ml of Asbrip every 12 hours and standard care with antivirals or not. Other 30 patients will be assigned to receive only standard care.

Treatment duration: 21 days

Objective of the study: to increase the effectiveness of therapy for patients with Covid-19 using food supplements Viusid and Asbrip.

Research objectives:

  1. To assess the clinical symptoms of Covid-19 in patients on the background of combination therapy with the inclusion of food supplements Viusid + Asbrip.
  2. To investigate the dynamics of indicators of laboratory diagnostics against the background of complex therapy with the inclusion of food additives Viusid + Asbrip in the complex treatment of Covid -19.
  3. To study the dynamics of indicators of instrumental methods of treatment.
  4. To develop an algorithm for the management of patients with coronavirus infection in order to increase the effectiveness of therapy and rehabilitation of patients with this pathology.
Being tested
Viusid and Asbrip, COVID-19 Standard Therapy
Keywords
covid-19, supportive care, Immuno-modulator, antiviral, symptoms relieve
Medical subject headings
COVID-19, Virus Diseases, Respiratory Tract Infections, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viusid and AsbripDietary supplement

    Patients will be assigned to receive daily oral doses of 4.5gr of Viusid and 10 ml of Asbrip every 8 hours and standard care.

  • COVID-19 Standard TherapyDrug

    Patients will be assigned to receive the standard therapy for COVID-19 disease: Antibiotic, Antivirals, Analgaesic, Anti-inflammatory drugs.

Study groups in NCT04980534
Study groupRoleWhat they receive
Viusid Plus Asbrip AdjuvantExperimental25 Patients who received standard therapy Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days AND Viusid (sachets with powder for dilution, oral administration) 1 sachet bid and Asbrip (liquid form, oral administration) 10 ml bid for the total duration of hospitalization. Time Frame: 21 days.
Receives: Dietary Supplement: Viusid and Asbrip; Drug: COVID-19 Standard Therapy
Viusid Plus Asbrip MonotherapyExperimental25 Patients who did not receive standard antiviral therapy with the inclusion of food supplements Viusid (4.5 gr every 12 hours, oral administration) and Asbrip (10 mL every 12 hours, oral administration). Time Frame: 21 days.
Receives: Dietary Supplement: Viusid and Asbrip
ControlActive comparator30 patients who received standard therapy (Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days), without the inclusion of food supplements Viusid and Asbrip.
Receives: Drug: COVID-19 Standard Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean duration of hospitalization.

    Media of time in days to discharge in each group. Discharge is considered once the patient complete the following conditions:

    • Normal body temperature for 2 days (36.1 - 37.2 degrees Celsius will be considered as normal body temperature).
    • Normal appetite for 4 days.
    • Normal Complete Blood Count (CBC): Following values will be considered as normal values in CBC:

    Red blood cell count: Male: 4.35-5.65 million cells/mcL; Female: 3.92-5.13 million cells/mcL. Hemoglobin: Male: 13.2-16.6 grams/dL; Female: 11.6-15 grams/dL. Hematocrit: Male: 38.3-48.6 percent; Female: 35.5-44.9 percent. White blood cell count: 3,400 to 9,600 cells/mcL. Platelet count: Male: 135-317 billion/L; Female: 157-371 billion/L.

    • No requirement in oxygen support.
    • Decrease in or normal CRP: 0.8-1.0 mg/dL (or 8-10 mg/L) or lower will be considered as normal values.
    • Any decrease in IL-6 level lower than doubled normal value: between 0 and 43.5 pg/ml will be considered as normal values.

    Measured: 21 days

Secondary outcomes (4)

  1. Mean levels of IL-6 concentration

    Mean of IL-6 concentration measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. IL-6 level lower than doubled normal value: between 0 and 43.5 pg/ml will be considered as normal values.

    Levels of IL-6 will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/).

    Measured: 21 days

  2. Peripheral blood c-reactive protein concentration

    Peripheral blood c-reactive protein concentration measured by blood biochemical analysis at day 0, 5, 10, 15 and 21.

    • 0.8-1.0 mg/dL (or 8-10 mg/L) or lower will be considered as normal values.

    Levels of CRP will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/).

    Measured: 21 days

  3. Mean levels of D-Dimer concentration

    Mean of D-dimer measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. D-Dimer level under 250 ng/mL, or under 0.4 μ/mL will be considered as normal value.

    Levels of D-Dimer will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/).

    Measured: 21 days

  4. Mean levels of Ferritin concentration

    Mean of D-dimer measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. In adult Males between 12 to 300 ng/mL; in adult Females between 12 to 150 ng/mL will be considered as normal values.

    Levels of Ferritin will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/).

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start8 Jan 2021
  3. Primary completion30 Jun 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04980534
Sponsor's protocol ID
COVID_KAZ_2021
Status last verified
Jul 2021
First submitted
26 Jul 2021
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 17311621

  • Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638.

    PubMed 20518086

  • Vilar Gomez E, Rodriguez De Miranda A, Gra Oramas B, Arus Soler E, Llanio Navarro R, Calzadilla Bertot L, Yasells Garcia A, Del Rosario Abreu Vazquez M. Clinical trial: a nutritional supplement Viusid, in combination with diet and exercise, in patients with nonalcoholic fatty liver disease. Aliment Pharmacol Ther. 2009 Nov 15;30(10):999-1009. doi: 10.1111/j.1365-2036.2009.04122.x. Epub 2009 Aug 18.

    PubMed 19691668

Questions about this trial

What is this clinical trial studying?

A study testing Viusid and Asbrip and COVID-19 Standard Therapy in people with Covid19 and COVID-19 Pneumonia, run by Catalysis SL at 3 sites in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean duration of hospitalization. (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04980534, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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