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Completed

NCT Number: NCT04980534

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

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.

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Key information

Conditions

Covid19 COVID-19 COVID-19 Pneumonia COVID-19 Respiratory Infection Coronaviridae Infections Coronavirus Infections Infection, Coronavirus Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV2 Infection Viral Infection Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City center for infectious diseases, Astana, Kazakhstan

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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.

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:

  • To assess the clinical symptoms of Covid-19 in patients on the background of combination therapy with the inclusion of food supplements Viusid + Asbrip.
  • 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.
  • To study the dynamics of indicators of instrumental methods of treatment.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viusid and Asbrip

Dietary 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 Therapy

Drug

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

Primary outcomes

  1. Mean duration of hospitalization.

    Time frame: 21 days

    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.

Secondary outcomes

  1. Mean levels of IL-6 concentration

    Time frame: 21 days

    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/).

  2. Peripheral blood c-reactive protein concentration

    Time frame: 21 days

    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/).

  3. Mean levels of D-Dimer concentration

    Time frame: 21 days

    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/).

  4. Mean levels of Ferritin concentration

    Time frame: 21 days

    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/).

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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