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

Catalysis SL

Status: Completed

Conditions: COVID-19 Respiratory Infection; COVID-19 Pneumonia; SARS-CoV2 Infection; Infection, Coronavirus; Covid19; Viral Infection; Respiratory Tract Infections

Treatments: Dietary Supplement: Viusid and Asbrip; Drug: COVID-19 Standard Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04980534

COVID_KAZ_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Viusid Plus Asbrip Adjuvant

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Viusid and Asbrip

Drug: COVID-19 Standard Therapy

Viusid Plus Asbrip Monotherapy

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Viusid and Asbrip

Control

Active Comparator group

Description:

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.

Treatment:

Drug: COVID-19 Standard Therapy