COVID 19Phase 3BISCUITNCT04424134
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
A Phase 3 study testing Bromhexine and Spironolactone and Base therapy in people with COVID 19, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
Trial summary
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Bromhexine and Spironolactone and Base therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 16 May 2020to 23 Aug 2020
- Phase
- Phase 3
- 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
- signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein > 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms
Who cannot join
- pregnancy and breastfeeding
- hypersensitivity to Spironolactone
- hypersensitivity to Bromhexine
- Known liver failure
- Glomerular filtration rate <20 ml/ min
- physician judgment that the patient will need mechanical ventilation in 24 hours
- other indications for Spironolactone
- Active cancer
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Oblast, 119620
Julia Begrambekova, Phd, +79854679273, begrambekova@ossn.ru
Yana Orlova, Professor, +791651663002, yaorlova@mc.msu.ru
About this study
Official title: Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.
- Conditions
- COVID 19
- Being tested
- Bromhexine and Spironolactone, Base therapy
- Keywords
- COVID 19, bromhexine, spironolactone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromhexine and SpironolactoneDrug
Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days
Base therapyDrug
Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment
| Study group | Role | What they receive |
|---|---|---|
| Bromhexine And Spironolactone | Experimental | Not described Receives: Drug: Bromhexine and Spironolactone |
| Base therapy | Active comparator | Not described Receives: Drug: Base therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
change in CAS COVID 19 between baseline and 12th +/- 2 days
CAS COVID 19 measures clinical and laboratory parameters in 7 domains:
respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4).
Minimal number of points - 0; max - 20.Lower the score-better health
Measured: baseline, day 12
Secondary outcomes (7)
- Combine endpoint -
time to death or mechanical ventilation
Measured: 12 days, 45 days
C-reactive protein
- Change from baseline in C-reactive protein
Measured: 12 days, 45 days
D-dimer
- Change from baseline in D-dimer
Measured: 12 days, 45 days
EuroQol Group. EQ-5D™
Change from baseline in EQ-5D.
The EQ-5D descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 12 days, 45 days
EuroQol Group. EQ VAS
Change from baseline in EQ VAS
EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
Measured: 12 days, 45 days
HADS
- Change from baseline Hospital Anxiety and Depression Scale/The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case
Measured: 14 days, 45 days
Hospital length of stay
Time from admission to the hospital to discharge form the hospital
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start16 May 2020
- Primary completion18 Jul 2020 (estimated)
- Study completion23 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424134
- Sponsor's protocol ID
- MSU160520
- Acronym
- BISCUIT
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
- ClinicalTrials.gov ID
- NCT04424134
- Acronym / sponsor ID
- BISCUIT / MSU160520
- Conditions
- COVID 19
- Keywords
- COVID 19, bromhexine, spironolactone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational CenterUniversity, hospital or other
- Study start
- 16 May 2020 (actual)
- Primary completion
- 18 Jul 2020 (estimated)
- Study completion
- 23 Aug 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromhexine And Spironolactone | Experimental | Drug: Bromhexine and Spironolactone |
| Base therapy | Active comparator | Drug: Base therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein > 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms
Key exclusion criteria (8 listed)
- pregnancy and breastfeeding
- hypersensitivity to Spironolactone
- hypersensitivity to Bromhexine
- Known liver failure
- Glomerular filtration rate <20 ml/ min
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 |
|---|---|---|
| Bromhexine and SpironolactoneBromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days | Drug | Bromhexine And Spironolactone |
| Base therapyTherapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment | Drug | Base therapy |
Primary outcome
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)
Time frame: baseline, day 12
change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20.Lower the score-better health
7 secondary outcomes
- Combine endpoint -
Time frame: 12 days, 45 days
C-reactive protein
Time frame: 12 days, 45 days
D-dimer
Time frame: 12 days, 45 days
EuroQol Group. EQ-5D™
Time frame: 12 days, 45 days
EuroQol Group. EQ VAS
Time frame: 12 days, 45 days
HADS
Time frame: 14 days, 45 days
Hospital length of stay
Time frame: up to 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromhexine and Spironolactone and Base therapy in people with COVID 19, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Begrambekova (+79854679273, julia.begrambekova@ossn.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical assessment score COVID 19 (CAS COVID 19) (time frame: baseline, day 12). 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 9 Jun 2020.