Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19
Covid-19, Sars-CoV2, Diabete Mellitus
About this trial
This is an interventional supportive care trial for Covid-19 focused on measuring Covid-19, SARS-CoV2, Immuno-modulator, antioxidant, nutritional supplement
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- None
Sites / Locations
- Hospital de Especialidades Dr. Teodoro Maldonado Carbo
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Viusid Plus Asbrip
Control
Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care. Treatment duration: 21 days.
A total of 60 subjects will be randomized 2: 1 in this study. 20 Control patients will be assigned to standard of care. Treatment duration: 21 days.