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 caused by 2019 coronavirus infection. 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 and 20 control patients with standard of care. Treatment duration: 21 days.
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 coronavirus and that the disease caused by it was named Coronavirus
Disease 2019 (COVID-19) by the WHO. Confirmed by comparative homology analysis, COVID-19 is
closely associated with the bat-like severe acute respiratory syndrome (SARS) coronavirus
(bat-SL-covzc45 and bat-SL-covzxc21, with 88% identity), but it is a far cry from coronavirus
of severe acute respiratory syndrome (SARS-CoV) (about 79%) and coronavirus from respiratory
syndrome of the Middle East (MERS-CoV) (about 50%). The National Health Commission of the
People's Republic of China reported a total of 77,658 confirmed cases, including 9,162 with
serious illnesses and 2,663 deaths as of February 25, 2020.ç
The new pathogen β-coronavirus was initially named as the new coronavirus (2019-nCoV), but on
January 12, 2020 the World Health Organization (WHO) named it coronavirus 2019 (COVID-19).
Epidemiological reports demonstrated high infectivity from person to person in social,
family, and hospital settings. Given this rapid increase in new cases worldwide, the WHO
declared a pandemic state 13 The results of a meta-analysis showed that the most prevalent
clinical symptom was fever (91.3%, 95% CI: 86-97%), followed by cough (67.7%, 95% CI:
59-76%), fatigue (51.0%, 95% CI: 34-68%) and dyspnea (30.4%, 95% CI: 21-40%). Comorbidities
included hypertension, diabetes, respiratory system disease, and cardiovascular disease. For
the Chinese Center for Disease Control and Prevention CDC, a suspected or probable case is
defined as a case that meets: (1) three clinical criteria or (2) two clinical criteria and
one epidemiological criterion. The clinical criteria are: fever; radiographic evidence of
pneumonia or acute respiratory distress syndrome; and low or normal white blood cell count or
low lymphocyte count. Epidemiological criteria are: living in Wuhan or history of travel to
Wuhan within 14 days before the onset of symptoms; contact with patients with fever and
symptoms of respiratory infection within 14 days prior to the onset of symptoms; and a link
to confirmed cases or groups of suspected cases. Defining a confirmed case, for the first
case in a province, is a suspected or probable case with detection of viral nucleic acid at
city CDC and provincial CDC. For the second case and all subsequent cases, the definition is
a suspected or probable case with detection of nucleic acid from the virus at CDC City. We
defined the cases as symptomatic individuals, which could be detected by means of a control
temperature across international borders, or who had a disease severity requiring hospital
admission, or both, plus travel history to Wuhan. 14 In Ecuador in the city of Guayaquil, the
Minister of Health, on February 29, 2020, confirmed the presence of the first "imported" case
of Covid-19 in Ecuador. It was an Ecuadorian citizen who arrived from Spain on February 14 at
the Guayaquil airport, who had no symptoms. Later days she presented discomfort and fever,
reasons for which she was hospitalized and the respective tests were performed for Covid-19
disease, which was positive.
On March 11, 2020, the WHO, the world health organization, officially declares the pandemic
caused by the SARS VOC-2 virus and in Ecuador the Emergency Operations Committee is
activated, in relation to this committee the following is detailed. The Emergency Operations
Committees are components of the Decentralized National Risk Management System, which are
responsible for planning and maintaining joint coordination and operation between different
levels and functions of the institutions involved in the response and attention to
emergencies and disasters in a field territorial defined. On March 12, 2020 two new people
tested positive. In total, 19 cases of COVID-19 are registered in Ecuador, the following day
the first person died from the coronavirus (COVID-19) occurred in Ecuador. On March 31, 2020,
there were 2,240 positive cases for COVID-19, 3,257 suspected, 2,485 discarded from a total
of 7,982 samples, 75 confirmed deaths; 61 probable deceased and 54 with hospital discharge.
At the beginning of April 2020, the Minister of Public Health, Juan Carlos Zevallos, in a
virtual press conference, announced that 100,000 rapid tests and 100,000 PCRs arrived in our
country that will serve to expedite the results of the exams for COVID-19.
Until the closing of this project, the records of the MSP indicated that on April 23, 2020,
there were 11,183 confirmed cases and 560 people dead. The city of Guayaquil with a
population of more than two million inhabitants with the increase in more positive and
suspicious cases, became the epicenter of the pandemic at the national level, in this
framework, the Teodoro Maldonado Carbo Specialty Hospital located at In the south of the
city, it is a third level hospital, since the aforementioned health crisis began with a high
influx of patients suspected of covid-19. Current treatment for COVID-19 is supportive, and
respiratory failure due to acute respiratory distress syndrome (ARDS) is the leading cause of
mortality. Ruan Q et al. Studied the predictors of mortality in a recent retrospective,
multicenter study of 150 confirmed cases of COVID-19 in Wuhan, China, including elevated
ferritin (mean 1297.6 ng / ml in non-survivors versus 614.0 ng / ml in survivors; p <0 · 001)
and IL-6 (p <0 · 0001), suggesting that mortality could be due to viral hyperinflammation.
There is an urgent need for effective treatment. The current focus has been on the
development of new therapies, which include antivirals and vaccines. Accumulated evidence
suggests that a subgroup of patients with severe COVID-19 may have cytokine storm syndrome.
Objectives:
Determine the safety and efficacy of Viusid + Asbrip in hospitalized patients with COVID-19
diagnosis.
Keep security through identification, proper and timely management of adverse events and
evaluation of biochemical parameters.
Measure efficacy through clinical improvement: evaluation of radiological signs and blood
analysis estableshed in this study.
Dietary Supplement: Viusid and Asbrip
Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours plus standard care. Viusid and Asbrip will be administered orally.
Treatment duration: 21 days.
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
Hospital de Especialidades Dr. Teodoro Maldonado Carbo
Guayaquil, Ecuador