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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407182
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

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 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.


Condition or disease Intervention/treatment Phase
Covid-19 Sars-CoV2 Diabete Mellitus Cardiopathy Pulmonary Disease Renal Disease Liver Diseases Dietary Supplement: Viusid and Asbrip Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : August 5, 2020
Estimated Study Completion Date : August 7, 2020

Arm Intervention/treatment
Experimental: Viusid Plus Asbrip

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.

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.


No Intervention: Control

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.




Primary Outcome Measures :
  1. Symptom resolution [ Time Frame: 21 days ]

    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.


Secondary Outcome Measures :
  1. Cumulative incidence of disease severity [ Time Frame: 21 days ]

    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.

  2. Complementary drugs required [ Time Frame: 21 days ]
    Differences in the number of patients who received complementary medications for diagnosis between the study arms.

  3. Side effects of supplementation [ Time Frame: 21 days ]
    Differences in the number of patients in the study groups experiencing side effects of the supplements.

  4. Duration of SARS-CoV-2 PCR positivity [ Time Frame: 21 days ]
    PCR analysis at day 0, 7th, 14th and 21th to measure and compare viral load

  5. Concentration of reactive protein c in peripheral blood [ Time Frame: 21 days ]
    Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th

  6. Incidence of hospitalization [ Time Frame: 21 days ]
    Number of Incidence of hospitalization

  7. Duration (days) of hospitalization [ Time Frame: 21 days ]
    Number of days of hospitalization

  8. Incidence of mechanical ventilation supply [ Time Frame: 21 days ]
    Number of Incidences of mechanical ventilation supply per patient

  9. Duration (days) of mechanical ventilation supply [ Time Frame: 21 days ]
    Number of days with mechanical ventilation supply

  10. Incidence of oxygen use [ Time Frame: 21 days ]
    Number of incidences of oxygen use

  11. Duration (days) of oxygen use [ Time Frame: 21 days ]
    Number of days of oxygen use per patient

  12. Mortality rate [ Time Frame: 21 days ]
    Number of death per group

  13. Time to return to normal activity [ Time Frame: 21 days ]
    Number of days patient need to recover from disease


Other Outcome Measures:
  1. Change from baseline in serum cytokine levels [ Time Frame: 21 days ]
    Change from baseline in serum cytokine IL-1 level by blood biochemical analysis at day 0, 3, 7, 14 and 21

  2. Change from baseline in serum cytokine levels [ Time Frame: 21 days ]
    Change from baseline in serum cytokine IL-6 level by blood biochemical analysis at day 0, 3, 7, 14 and 21

  3. Change from baseline in serum cytokine levels [ Time Frame: 21 days ]
    Change from baseline in serum cytokine TNF-α level by blood biochemical analysis at day 0, 3, 7, 14 and 21

  4. Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: 21 days ]
    Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages by blood biochemical analysis at day 0, 3, 7, 14 and 21

  5. Change from baseline in CD3 +, CD4 + and CD8 + T cell counts [ Time Frame: 21 days ]
    Change from baseline in CD3 +, CD4 + and CD8 + T cell counts by blood biochemical analysis at day 0, 3, 7, 14 and 21.

  6. Change in liver function test [ Time Frame: 21 days ]
    Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis at day 0, 4, 7, 14 and 21.

  7. Change in kidney function test [ Time Frame: 21 days ]
    Change in kidney function with eGFR rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.

  8. Change in kidney function test [ Time Frame: 21 days ]
    Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.

  9. Change in routine blood test [ Time Frame: 21 days ]
    Change in routine blood test red blood cells concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.

  10. Change in routine blood test [ Time Frame: 21 days ]
    Change in routine blood test white blood cell concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.

  11. Change in routine blood test [ Time Frame: 21 days ]
    Change in routine blood test D-dimer level by blood biochemical analysis at day 0, 4, 7, 14 and 21.

  12. Change in routine blood test [ Time Frame: 21 days ]
    Change in routine blood test fibrinogen level by blood biochemical analysis at day 0, 4, 7, 14 and 21.

  13. Change in myocardial enzymes [ Time Frame: 21 days ]
    Change in myocardial enzyme CPK-MB by blood biochemical analysis at daty 0, 4, 7, 14 and 21

  14. Change in myocardial enzymes [ Time Frame: 21 days ]
    Change in myocardial enzymes troponins by blood biochemical analysis at daty 0, 4, 7, 14 and 21



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407182


Contacts
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Contact: Martha Heras Veloz, Dr. 0999970284 martha.heras@iess.gob.ec
Contact: Wilson Benites, Dr. 0999970284

Locations
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Ecuador
Hospital de Especialidades Dr. Teodoro Maldonado Carbo Recruiting
Guayaquil, Ecuador, 090510
Contact: Martha Heras Veloz, Dr.         
Sub-Investigator: Mario Mero, Dr.         
Sub-Investigator: Martha Heras Veloz, Dr.         
Principal Investigator: Wilson Benites I., Dr.         
Sponsors and Collaborators
Catalysis SL
Additional Information:
Publications:

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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT04407182    
Other Study ID Numbers: IESS-HTMC-JUTD-2020-0305-M
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catalysis SL:
Covid-19
SARS-CoV2
Immuno-modulator
antioxidant
nutritional supplement
Additional relevant MeSH terms:
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Liver Diseases
Diabetes Mellitus
Digestive System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases