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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2021-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Viusid Plus Asbrip Adjuvant

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.

Group Type EXPERIMENTAL

Viusid and Asbrip

Intervention Type 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

Intervention Type DRUG

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

Viusid Plus Asbrip Monotherapy

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.

Group Type EXPERIMENTAL

Viusid and Asbrip

Intervention Type 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.

Control

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.

Group Type ACTIVE_COMPARATOR

COVID-19 Standard Therapy

Intervention Type DRUG

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

Interventions

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Viusid and Asbrip

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.

Intervention Type DIETARY_SUPPLEMENT

COVID-19 Standard Therapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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%.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No