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Covid-19Phase 2NCT04407182

Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19

A Phase 2 study testing Viusid and Asbrip in people with Covid-19 and Sars-CoV2, run by Catalysis SL at 1 site in Ecuador.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 caused by 2019 coronavirus infection. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Covid-19, Sars-CoV2, Diabete Mellitus
What is being tested?
Viusid and Asbrip
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEcuador
Study dates
4 May 2020to 1 Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Ecuador1 site
  • Hospital de Especialidades Dr. Teodoro Maldonado Carbo

    Guayaquil, 090510

Other trials in Ecuador

About this study

Official title: Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients in Teodoro Maldonado Carbo Specialty's Hospital Infected and Diagnosed by SARS-Cov-2 With COVID-19

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.

Read the 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 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.

Being tested
Viusid and Asbrip
Keywords
Covid-19, SARS-CoV2, Immuno-modulator, antioxidant, nutritional supplement
Medical subject headings
COVID-19, Diabetes Mellitus, Heart Diseases, Lung Diseases, Kidney Diseases, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viusid and AsbripDietary supplement

    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.

Study groups in NCT04407182
Study groupRoleWhat they receive
Viusid Plus AsbripExperimentalPatients 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.
Receives: Dietary Supplement: Viusid and Asbrip
ControlNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom resolution

    The number of days required to achieve a score of 0 for each symptom category.

    1. Resolution of symptoms: fever (time frame: 21 days) Fever based on a 0-3 scale: 0 = ≤98.6, 1 => 98.6- 100.6, 2 => 100.6 - 102.6, 3 => 102.6
    2. Resolution of symptoms: cough (time frame: 21 days) Cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe
    3. Resolution of symptoms: shortness of breath (time frame: 21 days) Shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = walking on a flat surface 3 = shortness of breath when dressing or doing daily activities
    4. Resolution of symptoms: fatigue (period: 21 days) Fatigue based on a 0-3 scale: 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue.
    5. Composite score that includes all symptoms: (time frame: 21 days) Total composite score of symptoms on days 5, 10, 15, and 21 of study supplementation.

    Measured: 21 days

Secondary outcomes (13)
  1. Cumulative incidence of disease severity

    Disease severity will be measured using a disease severity clinical event scale (assessed until day 21) Change from baseline in the patient's health status on an ordinal scale of 7 categories (time frame: days 3, 7, 14, 21)

    1. death
    2. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    3. Hospitalized, with non-invasive ventilation or high-flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, which does not require supplemental oxygen
    6. Not hospitalized, limitation of activities.
    7. Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.

    Measured: 21 days

  2. Complementary drugs required

    Differences in the number of patients who received complementary medications for diagnosis between the study arms.

    Measured: 21 days

  3. Side effects of supplementation

    Differences in the number of patients in the study groups experiencing side effects of the supplements.

    Measured: 21 days

  4. Duration of SARS-CoV-2 PCR positivity

    PCR analysis at day 0, 7th, 14th and 21th to measure and compare viral load

    Measured: 21 days

  5. Concentration of reactive protein c in peripheral blood

    Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th

    Measured: 21 days

  6. Incidence of hospitalization

    Number of Incidence of hospitalization

    Measured: 21 days

  7. Duration (days) of hospitalization

    Number of days of hospitalization

    Measured: 21 days

  8. Incidence of mechanical ventilation supply

    Number of Incidences of mechanical ventilation supply per patient

    Measured: 21 days

  9. Duration (days) of mechanical ventilation supply

    Number of days with mechanical ventilation supply

    Measured: 21 days

  10. Incidence of oxygen use

    Number of incidences of oxygen use

    Measured: 21 days

  11. Duration (days) of oxygen use

    Number of days of oxygen use per patient

    Measured: 21 days

  12. Mortality rate

    Number of death per group

    Measured: 21 days

  13. Time to return to normal activity

    Number of days patient need to recover from disease

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start4 May 2020
  3. Primary completion1 Aug 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407182
Sponsor's protocol ID
IESS-HTMC-JUTD-2020-0305-M
Status last verified
May 2020
First submitted
25 May 2020
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Hui DS, I Azhar E, Madani TA, Ntoumi F, Kock R, Dar O, Ippolito G, Mchugh TD, Memish ZA, Drosten C, Zumla A, Petersen E. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health - The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis. 2020 Feb;91:264-266. doi: 10.1016/j.ijid.2020.01.009. Epub 2020 Jan 14. No abstract available.

    PubMed 31953166
  • Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.

    PubMed 32007145
  • Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

    PubMed 32173574
  • Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.

    PubMed 32113704
  • Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.

    PubMed 32014114
  • Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.

    PubMed 32119824
  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PubMed 32192578
  • Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

    PubMed 32125452

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Viusid and Asbrip in people with Covid-19 and Sars-CoV2, run by Catalysis SL at 1 site in Ecuador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom resolution (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407182, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

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