NCT04980534

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

April 13, 2022

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 26, 2021

Last Update Submit

April 5, 2022

Conditions

Covid19COVID-19 PneumoniaCOVID-19 Respiratory InfectionViral InfectionRespiratory Tract InfectionsInfection, CoronavirusSARS-CoV2 Infection

Keywords

covid-19supportive careImmuno-modulatorantiviralsymptoms relieve

Outcome Measures

Primary Outcomes (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.

    21 days

Secondary Outcomes (4)

  • Mean levels of IL-6 concentration

    21 days

  • Peripheral blood c-reactive protein concentration

    21 days

  • Mean levels of D-Dimer concentration

    21 days

  • Mean levels of Ferritin concentration

    21 days

Study Arms (3)

Viusid Plus Asbrip Adjuvant

EXPERIMENTAL

25 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.

Dietary Supplement: Viusid and AsbripDrug: COVID-19 Standard Therapy

Viusid Plus Asbrip Monotherapy

EXPERIMENTAL

25 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.

Dietary Supplement: Viusid and Asbrip

Control

ACTIVE COMPARATOR

30 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.

Drug: COVID-19 Standard Therapy

Interventions

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.

Viusid Plus Asbrip AdjuvantViusid Plus Asbrip Monotherapy
COVID-19 Standard TherapyDRUG

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

ControlViusid Plus Asbrip Adjuvant

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City center for infectious diseases

Astana, Astana, 010000, Kazakhstan

Location

City children hospital â„–1

Astana, Astana, 020000, Kazakhstan

Location

JSC "Astana Medical University

Astana, 010000, Kazakhstan

Location

Related Publications (3)

  • 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: 17311621RESULT

  • 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.

    PMID: 20518086RESULT

  • 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.

    PMID: 19691668RESULT

Related Links

MeSH Terms

Conditions

COVID-19Virus DiseasesRespiratory Tract InfectionsCoronavirus Infections

Interventions

Viusid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

July 28, 2021

Study Start

January 8, 2021

Primary Completion

June 30, 2021

Study Completion

September 15, 2021

Last Updated

April 13, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

KA(3)