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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)

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Page 1 of 1 (2 locations)

1

MBAL, Sv. Mina

Plovdiv, Bulgaria, 4000

2

MTB Plovdiv

Plovdiv, Bulgaria, 4004