Coronavirus InfectionPhase 3SPIDEX-IINCT04826822
Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19
A Phase 3 study testing Spironolactone + Dexamethasone and Standard-of-care SARS-CoV-2 treatment in people with Coronavirus Infection and Pneumonia, Viral, run by Chita State Regional Clinical Hospital Number 1 at 1 site in Russia.
Trial summary
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, Pneumonia, Viral
- What is being tested?
- Spironolactone + Dexamethasone and Standard-of-care SARS-CoV-2 treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteRussia
- Study dates
- 24 Feb 2021to 2 Sep 2021
- 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
- Age 18 years or above;
- Signed informed consent;
- PCR-confirmed diagnosis of SARS-CoV-2 infection
- Presenting with moderate-to-severe disease (scores 4-6 on WHO ordinal scale)
Who cannot join
- Women of childbearing age without a negative urine pregnancy test, currently pregnant or breastfeeding women;
- Severe heart failure (NYHA4), severe renal failure (eGFR < 30 ml/min/1.73 m2), severe liver failure (ALT/AST ratio > 5 norms), severe anemia (haemoglobin < 30 g/l)
- Participating in another clinical trial
- Severe electrolyte imbalance (hyperkalemia > 5.0 mmol/l, hyponatremia < 120 mmol/l)
- Hypersensitivity or contraindications to the study drugs (spironolactone and dexamethasone)
- Renal dialysis
- Severe uncontrolled diabetes mellitus
- Patient receiving one of the following medications that cannot be substituted over the trial duration: ACE inhibitors, amiloride, eplerenone, cortisone acetate, potassium canrenoate, triamterene
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Chita State Regional Clinical Hospital Number 1
Chita, 672039
Sergey Lukyanov, MD, +7 924 277-29-71, lukyanov-sergei@mail.ru
About this study
Official title: Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.
- Conditions
- Coronavirus Infection, Pneumonia, Viral
- Being tested
- Spironolactone + Dexamethasone, Standard-of-care SARS-CoV-2 treatment
- Medical subject headings
- Coronavirus Infections, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone + DexamethasoneDrug
Low doses of orally administered spironolactone and dexamethasone
Standard-of-care SARS-CoV-2 treatmentDrug
Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | After randomisation (Day 1): Spironolactone [100 mg 1x/day] + dexamethasone [2 mg 2x/day, 12/12h] Days 2-12*: Spironolactone [50 mg 2x/day, 12/12h] + dexamethasone [2 mg 2x/day, 12/12h] Days 13-20: Spironolactone [25 mg 2x/day, 12/12h] Days 21-28: Spironolactone [25 mg 1x/day] Standard treatment is according to the treatment protocol for 2019-nCoV infection.
*In case of cortisol levels above 100 nmol/L on days 3 and 4, the dexamethasone dose should be increased to 3 mg in the morning and in the evening (total 6 mg per day). Receives: Drug: Spironolactone + Dexamethasone |
| Control | Active comparator | Patients receiving standard-of-care treatment for SARS-CoV-2 infection as regulated by the relevant guidelines of the Ministry of Healthcare of the Russian Federation Receives: Drug: Standard-of-care SARS-CoV-2 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical status
Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
Measured: Day 14 post-randomization
Secondary outcomes (9)
28-day all-cause mortality
All-cause mortality at 28 days post-randomization
Measured: 28 days post-randomization
Oxygen-free days
The number of days without oxygen support of any type
Measured: 28 days post-randomization
Ventilator-free days
The number of days without invasive mechanical ventilation
Measured: 28 days post-randomization
Invasive mechanical ventilation
The number of patients requiring invasive mechanical ventilation during hospitalization and the number of days spent on newly-administered invasive mechanical ventilation
Measured: 28 days post-randomization
Time to discharge
The number of days from hospitalization to discharge
Measured: 28 days post-randomization
Length of ICU stay
The number of days spent in the intensive care unit
Measured: 28 days post-randomization
New ICU admission
The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer
Measured: 28 days post-randomization
Long-COVID development
The number of patients with signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis (Post-COVID-19 syndrome as defined by the relevant NICE guidance)
Measured: 60 and 90 days post-admission
Evaluation of the clinical status
Clinical status at day 7 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
Measured: Day 7 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start24 Feb 2021
- Primary completion8 Jul 2021 (estimated)
- Study completion2 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chita State Regional Clinical Hospital Number 1
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Lukyanov, MD, Principal investigator, Chita State Regional Clinical Hospital Number 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826822
- Sponsor's protocol ID
- SPII_1789461
- Acronym
- SPIDEX-II
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD would require material transfer agreement according to the local rules and regulations. The study protocol, statistical analysis plan, and the translated version of the informed consent form can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04826822
- Acronym / sponsor ID
- SPIDEX-II / SPII_1789461
- Conditions
- Coronavirus Infection, Pneumonia, Viral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Chita State Regional Clinical Hospital Number 1Other government
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 8 Jul 2021 (estimated)
- Study completion
- 2 Sep 2021 (estimated)
- First posted
- 1 Apr 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.
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Spironolactone + DexamethasoneAfter randomisation (Day 1): Spironolactone [100 mg 1x/day] + dexamethasone [2 mg 2x/day, 12/12h] Days 2-12*: Spironolactone [50 mg 2x/day, 12/12h] + dexamethasone [2 mg 2x/day, 12/12h] Days 13-20: Spironolactone [25 mg 2x/day, 12/12h] Days 21-28: Spironolactone [25 mg 1x/day] Standard treatment is according to the treatment protocol for 2019-nCoV infection. *In case of cortisol levels above 100 nmol/L on days 3 and 4, the dexamethasone dose should be increased to 3 mg in the morning and in the evening (total 6 mg per day). |
| Control | Active comparator | Drug: Standard-of-care SARS-CoV-2 treatmentPatients receiving standard-of-care treatment for SARS-CoV-2 infection as regulated by the relevant guidelines of the Ministry of Healthcare of the Russian Federation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above;
- Signed informed consent;
- PCR-confirmed diagnosis of SARS-CoV-2 infection
- Presenting with moderate-to-severe disease (scores 4-6 on WHO ordinal scale)
Key exclusion criteria (8 listed)
- Women of childbearing age without a negative urine pregnancy test, currently pregnant or breastfeeding women;
- Severe heart failure (NYHA4), severe renal failure (eGFR < 30 ml/min/1.73 m2), severe liver failure (ALT/AST ratio > 5 norms), severe anemia (haemoglobin < 30 g/l)
- Participating in another clinical trial
- Severe electrolyte imbalance (hyperkalemia > 5.0 mmol/l, hyponatremia < 120 mmol/l)
- Hypersensitivity or contraindications to the study drugs (spironolactone and dexamethasone)
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 |
|---|---|---|
| Spironolactone + DexamethasoneLow doses of orally administered spironolactone and dexamethasone | Drug | Treatment |
| Standard-of-care SARS-CoV-2 treatmentStandard-of-care SARS-CoV-2 treatment administered according to the local guidelines | Drug | Control |
Primary outcome
Evaluation of the clinical status
Time frame: Day 14 post-randomization
Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
9 secondary outcomes
28-day all-cause mortality
Time frame: 28 days post-randomization
Oxygen-free days
Time frame: 28 days post-randomization
Ventilator-free days
Time frame: 28 days post-randomization
Invasive mechanical ventilation
Time frame: 28 days post-randomization
Time to discharge
Time frame: 28 days post-randomization
Length of ICU stay
Time frame: 28 days post-randomization
New ICU admission
Time frame: 28 days post-randomization
Long-COVID development
Time frame: 60 and 90 days post-admission
Evaluation of the clinical status
Time frame: Day 7 post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No. Sharing IPD would require material transfer agreement according to the local rules and regulations. The study protocol, statistical analysis plan, and the translated version of the informed consent form can be shared upon request.
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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.
Sergey Lukyanov, MD principal investigator
Chita State Regional Clinical Hospital Number 1
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 Spironolactone + Dexamethasone and Standard-of-care SARS-CoV-2 treatment in people with Coronavirus Infection and Pneumonia, Viral, run by Chita State Regional Clinical Hospital Number 1 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 4 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 1 Apr 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 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 Sergey Lukyanov, MD (+79242772971, lukyanov-sergei@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the clinical status (time frame: Day 14 post-randomization). 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 1 Apr 2021.