Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
NCT ID: NCT04701502
Last Updated: 2021-10-21
Study Results
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2020-11-09
2021-02-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interventional
A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.
Treatment duration: 21 days.
Viusid
Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally.
Treatment duration: 21 days
Asbrip
Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally.
Treatment duration: 21 days
Standard Care
Standard care for COVID-19
Control
A total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only.
Treatment duration: 21 days.
Standard Care
Standard care for COVID-19
Interventions
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Viusid
Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally.
Treatment duration: 21 days
Asbrip
Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally.
Treatment duration: 21 days
Standard Care
Standard care for COVID-19
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Catalysis SL
INDUSTRY
Responsible Party
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Locations
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MBAL, Sv. Mina
Plovdiv, , Bulgaria
MTB Plovdiv
Plovdiv, , Bulgaria
Countries
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Other Identifiers
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COVID_BULG_2020
Identifier Type: -
Identifier Source: org_study_id