Covid19Phase 2NCT04701502
Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
A Phase 2 study testing Viusid and Asbrip in people with Covid19 and Respiratory Disease, run by Catalysis SL at 2 sites in Bulgaria.
Trial summary
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Respiratory Disease, Immune System
- 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
- 2 sitesBulgaria
- Study dates
- 9 Nov 2020to 15 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults aged ≥18 years at the time of enrollment.
- Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
- Mild (uncomplicated) Illness:
- Diagnosed with COVID-19 by a standardized RT-PCR assay and
- Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and
- No signs of a more serious lower airway disease and
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- RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air
- Moderate Illness:
- Diagnosed with COVID-19 by a standardized RT-PCR assay and
- In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (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% on room air and
- If available, lung infiltrates based on X-ray or CT scan < 50% present
- Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
Who cannot join
- Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
- Subjects showing signs of clinical jaundice at the time of screening.
- History of moderate and severe liver disease (Child-Pugh score >12).
- Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
- History of uncontrolled diabetes.
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- History of severe chronic kidney disease or requiring dialysis.
- Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
- Patients with malignant tumor, or other serious systemic diseases.
- Patients who are participating in other clinical trials.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Viusid or Asbrip are not eligible.
- Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.
Trial locations and contacts
2 sites in 1 country.
About this study
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
Read the detailed description
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
A total of 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.
Treatment duration: 21 days
- Conditions
- Covid19, Respiratory Disease, Immune System, Immunomodulator, Antiseptic, Supportive Care
- Being tested
- Viusid, Asbrip, Standard Care
- Medical subject headings
- COVID-19, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViusidDietary supplement
Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally.
Treatment duration: 21 days
AsbripDietary supplement
Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally.
Treatment duration: 21 days
Standard CareDrug
Standard care for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.
Treatment duration: 21 days. Receives: Dietary Supplement: Viusid; Dietary Supplement: Asbrip; Drug: Standard Care |
| Control | Other | A total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only.
Treatment duration: 21 days. Receives: Drug: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
Clinical Improvement as assessed by change in total symptom score ranging from 0-12.
The symptom score includes: [everyday assessment, up to 21 days].
- Fever (temperature in oC) based on a scale 0-3: 0 <36,7; 1 =36,7-37,8; 2 =37,8-38,9; 3 > 38,9.
- Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe.
- Shortness of breath based on a scale 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise, 2 = with walking on flat surface, 3 = short of breath with getting dressed or daily activities.
- Fatigue on a 0-3 scale: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue.
Composite score is a sum of mentioned four symptom scores, assessed every day up to 21 days. It ranges from 0 to 12.
Measured: 21 days
Time to semirecover
Efficacy will be determined by the number of days required to reach a 50 percent reduction in the composite score, i.e. "time to semirecovery" (primary outcome measure).
Measured: 21 days
Symptom resolution
Symptom resolution of COVID-19 disease The number of days required to reach symptom score <0,25 for each one of four symptom category mentioned before.
Measured: 21 days
Time to recovery
Time (days) to recovery from COVID-19 disease The number of days required to reach composite score <1.
Measured: 21 days
Secondary outcomes (9)
Cumulative assessment 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.
- Death
- Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, with non-invasive ventilation or high-flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, which does not require supplemental oxygen
- Not hospitalized, limitation of activities.
- Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.
Note: lower scores mean a worse outcome
Measured: 21 days
Duration of SARS-CoV-2 PCR positivity
Daily PCR analysis to measure and compare viral load
Measured: 21 days
Concentration of C-reactive protein in peripheral blood
Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.
Measured: 21 days
Incidence of hospitalization
Number of Incidence of hospitalization
Measured: 21 days
Duration (days) of hospitalization
Number of days of hospitalization
Measured: 21 days
Incidence of mechanical ventilation supply
Number of incidences of mechanical ventilation supply per patient
Measured: 21 days
Incidence of oxygen use
Number of incidences of oxygen use
Measured: 21 days
Duration (days) of oxygen use
Number of days of oxygen use per patient
Measured: 21 days
Mortality rate
Number of death per group
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start9 Nov 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701502
- Sponsor's protocol ID
- COVID_BULG_2020
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04701502
- Acronym / sponsor ID
- COVID_BULG_2020
- Conditions
- Covid19, Respiratory Disease, Immune System, Immunomodulator, Antiseptic, Supportive Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
Detailed description
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
A total of 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.
Treatment duration: 21 days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: Viusid, Dietary Supplement: Asbrip, Drug: Standard CareA total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital. Treatment duration: 21 days. |
| Control | Other | Drug: Standard CareA total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only. Treatment duration: 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female adults aged ≥18 years at the time of enrollment.
- Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
- Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
Key exclusion criteria (12 listed)
- Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
- Subjects showing signs of clinical jaundice at the time of screening.
- History of moderate and severe liver disease (Child-Pugh score >12).
- Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViusidPatients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally. Treatment duration: 21 days | Dietary supplement | Interventional |
| AsbripPatients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally. Treatment duration: 21 days | Dietary supplement | Interventional |
| Standard CareStandard care for COVID-19 | Drug | Control, Interventional |
Primary outcome
Clinical Improvement
Time frame: 21 days
Clinical Improvement as assessed by change in total symptom score ranging from 0-12. The symptom score includes: [everyday assessment, up to 21 days]. 1. Fever (temperature in oC) based on a scale 0-3: 0 <36,7; 1 =36,7-37,8; 2 =37,8-38,9; 3 > 38,9. 2. Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe. 3. Shortness of breath based on a scale 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise, 2 = with walking on flat surface, 3 = short of breath with getting dressed or daily activities. 4. Fatigue on a 0-3 scale: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue. Composite score is a sum of mentioned four symptom scores, assessed every day up to 21 days. It ranges from 0 to 12.
Time to semirecover
Time frame: 21 days
Efficacy will be determined by the number of days required to reach a 50 percent reduction in the composite score, i.e. "time to semirecovery" (primary outcome measure).
Symptom resolution
Time frame: 21 days
Symptom resolution of COVID-19 disease The number of days required to reach symptom score <0,25 for each one of four symptom category mentioned before.
Time to recovery
Time frame: 21 days
Time (days) to recovery from COVID-19 disease The number of days required to reach composite score <1.
9 secondary outcomes
Cumulative assessment of disease severity
Time frame: 21 days
Duration of SARS-CoV-2 PCR positivity
Time frame: 21 days
Concentration of C-reactive protein in peripheral blood
Time frame: 21 days
Incidence of hospitalization
Time frame: 21 days
Duration (days) of hospitalization
Time frame: 21 days
Incidence of mechanical ventilation supply
Time frame: 21 days
Incidence of oxygen use
Time frame: 21 days
Duration (days) of oxygen use
Time frame: 21 days
Mortality rate
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viusid and Asbrip in people with Covid19 and Respiratory Disease, run by Catalysis SL at 2 sites in Bulgaria.
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 15 inclusion and 12 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. 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?
Clinical Improvement (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2021.