Clinical trial NCT04980534: Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip
Official title: Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
Viral Infection
Respiratory Tract Infections
Infection, Coronavirus
SARS-CoV2 Infection
Keywords: covid-19
supportive care
Immuno-modulator
antiviral
symptoms relieve
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean duration of hospitalization.
timeFrame: 21 days
Secondary outcomes:
measure: Mean levels of IL-6 concentration
timeFrame: 21 days
measure: Peripheral blood c-reactive protein concentration
timeFrame: 21 days
measure: Mean levels of D-Dimer concentration
timeFrame: 21 days
measure: Mean levels of Ferritin concentration
timeFrame: 21 days
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: City center for infectious diseases
state: Nur-Sultan
city: Astana
country: Kazakhstan
facility: City children hospital №1
state: Nur-Sultan
city: Astana
country: Kazakhstan
facility: JSC "Astana Medical University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.