Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19

This is a two-arm, randomized, open label, two-center, 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 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.

Treatment duration: 21 days

Inclusion criteria

• Male or female adults aged ≥18 years at the time of enrollment.
• Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:

Mild (uncomplicated) Illness:

• Diagnosed with COVID-19 by a standardized RT-PCR assay and
• Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and
• No signs of a more serious lower airway disease and
• RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air

Moderate Illness:

• Diagnosed with COVID-19 by a standardized RT-PCR assay and
• In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) or
• Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) > 93% on room air and
• If available, lung infiltrates based on X-ray or CT scan < 50% present
• Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.

Exclusion criteria

• Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
• History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
• Subjects showing signs of clinical jaundice at the time of screening.
• History of moderate and severe liver disease (Child-Pugh score >12).
• Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
• History of uncontrolled diabetes.
• History of severe chronic kidney disease or requiring dialysis.
• Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
• Patients with malignant tumor, or other serious systemic diseases.
• Patients who are participating in other clinical trials.
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Viusid or Asbrip are not eligible.

Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.