Status:
COMPLETED
Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
Lead Sponsor:
Catalysis SL
Conditions:
Covid19
Respiratory Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 cau...
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 cau...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04701502
Start Date
November 9 2020
End Date
February 15 2021
Last Update
October 21 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
MBAL, Sv. Mina
Plovdiv, Bulgaria, 4000
2
MTB Plovdiv
Plovdiv, Bulgaria, 4004