Status:
COMPLETED
Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19
Lead Sponsor:
Catalysis SL
Conditions:
Covid-19
Sars-CoV2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease cau...
Detailed Description
In December 2019, a group of "pneumonia of unknown origin" cases were reported in Wuhan, China. Only a few days later, Chinese health authorities confirmed that this group was associated with the coro...
Eligibility Criteria
Inclusion
- Population over 18 years of age up to 70, sample size 30.
- Subjects with mild to moderate\* symptoms of respiratory illness caused by 2019 coronavirus infection as defined below: Mild disease (uncomplicated):
- Diagnosed with COVID-19 by a standardized RT-PCR assay and Mild symptoms, such as fever, runny nose, mild cough, sore throat, malaise, headache, muscle pain, or discomfort, but no shortness of breath and No signs of more serious lower airway disease.
- RR \<20, HR \<90, oxygen saturation (pulse oximetry)\> 93% in ambient air.
- \*Moderate illness:
- Diagnosed with COVID-19 by a standardized RT-PCR assay and
- In addition to the above symptoms, more significant lower respiratory symptoms, including difficulty breathing (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% in ambient air, and
- If available, X-ray or computed tomography-based lung infiltrates \<50% present 3. 12-lead ECG at rest clinically normal at the screening visit or, if abnormal, not considered clinically significant by the lead investigator.
- 4\. The subject (or legally authorized representative) provides her informed written consent before starting any study procedure.
- 5\. Understand and agree to comply with planned study procedures. 6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (eg, barrier contraceptives \[condom or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combined oral contraceptives, transdermal patches or rings) \] or intrauterine devices) for the duration of the study.
Exclusion
- None
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04407182
Start Date
May 4 2020
End Date
October 1 2020
Last Update
January 8 2021
Active Locations (1)
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1
Hospital de Especialidades Dr. Teodoro Maldonado Carbo
Guayaquil, Ecuador, 090510