Clinical trial NCT04701502: Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
Official title: Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Respiratory Disease
Immune System
Immunomodulator
Antiseptic
Supportive Care
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
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, 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Male or female adults aged ≥18 years at the time of enrollment.
2. 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
3. Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
5. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
3. Subjects showing signs of clinical jaundice at the time of screening.
4. History of moderate and severe liver disease (Child-Pugh score \>12).
5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
6. History of uncontrolled diabetes.
7. History of severe chronic kidney disease or requiring dialysis.
8. 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.
9. Patients with malignant tumor, or other serious systemic diseases.
10. Patients who are participating in other clinical trials.
11. 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.

Primary outcomes:
measure: Clinical Improvement
timeFrame: 21 days
measure: Time to semirecover
timeFrame: 21 days
measure: Symptom resolution
timeFrame: 21 days
measure: Time to recovery
timeFrame: 21 days
Secondary outcomes:
measure: Cumulative assessment of disease severity
timeFrame: 21 days
measure: Duration of SARS-CoV-2 PCR positivity
timeFrame: 21 days
measure: Concentration of C-reactive protein in peripheral blood
timeFrame: 21 days
measure: Incidence of hospitalization
timeFrame: 21 days
measure: Duration (days) of hospitalization
timeFrame: 21 days
measure: Incidence of mechanical ventilation supply
timeFrame: 21 days
measure: Incidence of oxygen use
timeFrame: 21 days
measure: Duration (days) of oxygen use
timeFrame: 21 days
measure: Mortality rate
timeFrame: 21 days
Other outcomes:
measure: Change in liver function test
timeFrame: 21 days
measure: Change in kidney function test
timeFrame: 21 days
measure: Change in routine blood test
timeFrame: 21 days
measure: Change in routine blood test
timeFrame: 21 days
measure: Change in routine blood test
timeFrame: 21 days
measure: Change in routine blood test
timeFrame: 21 days
Locations:
city: Plovdiv
country: Bulgaria
facility: MBAL, Sv. Mina
city: Plovdiv
country: Bulgaria
facility: MTB Plovdiv
Study officials:
References: