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Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19 (SPIDEX-II)

Primary Purpose

Coronavirus Infection, Pneumonia, Viral

Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Spironolactone + Dexamethasone
Standard-of-care SARS-CoV-2 treatment
Sponsored by
Chita State Regional Clinical Hospital Number 1
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Chita State Regional Clinical Hospital Number 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

28-day all-cause mortality
All-cause mortality at 28 days post-randomization
Oxygen-free days
The number of days without oxygen support of any type
Ventilator-free days
The number of days without invasive mechanical ventilation
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
Time to discharge
The number of days from hospitalization to discharge
Length of ICU stay
The number of days spent in the intensive care unit
New ICU admission
The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer
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)
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)

Full Information

First Posted
March 28, 2021
Last Updated
March 31, 2021
Sponsor
Chita State Regional Clinical Hospital Number 1
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1. Study Identification

Unique Protocol Identification Number
NCT04826822
Brief Title
Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19
Acronym
SPIDEX-II
Official Title
Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Anticipated)
Study Completion Date
September 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chita State Regional Clinical Hospital Number 1

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Pneumonia, Viral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Spironolactone + Dexamethasone
Intervention Description
Low doses of orally administered spironolactone and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Standard-of-care SARS-CoV-2 treatment
Intervention Description
Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines
Primary Outcome Measure Information:
Title
Evaluation of the clinical status
Description
Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
Time Frame
Day 14 post-randomization
Secondary Outcome Measure Information:
Title
28-day all-cause mortality
Description
All-cause mortality at 28 days post-randomization
Time Frame
28 days post-randomization
Title
Oxygen-free days
Description
The number of days without oxygen support of any type
Time Frame
28 days post-randomization
Title
Ventilator-free days
Description
The number of days without invasive mechanical ventilation
Time Frame
28 days post-randomization
Title
Invasive mechanical ventilation
Description
The number of patients requiring invasive mechanical ventilation during hospitalization and the number of days spent on newly-administered invasive mechanical ventilation
Time Frame
28 days post-randomization
Title
Time to discharge
Description
The number of days from hospitalization to discharge
Time Frame
28 days post-randomization
Title
Length of ICU stay
Description
The number of days spent in the intensive care unit
Time Frame
28 days post-randomization
Title
New ICU admission
Description
The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer
Time Frame
28 days post-randomization
Title
Long-COVID development
Description
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)
Time Frame
60 and 90 days post-admission
Title
Evaluation of the clinical status
Description
Clinical status at day 7 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
Time Frame
Day 7 post-randomization
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Incidence of adverse events related to the use of the investigational products
Time Frame
28 days post-randomization
Title
Laboratory abnormalities
Description
Occurrence of laboratory hematimetric parameters, creatinine, d-dimer, c-reactive protein
Time Frame
28 days post-randomization
Title
Change in classic cough score
Description
Change in classic cough score measured daily in hospitalized patients
Time Frame
28 days post-randomization
Title
Radiological abnormalities
Description
Occurrence of viral pneumonia-associated changes on sequential chest CT scans in hospitalized patients
Time Frame
28 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Lukyanov, MD
Phone
+79242772971
Email
lukyanov-sergei@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Lukyanov, MD
Organizational Affiliation
Chita State Regional Clinical Hospital Number 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chita State Regional Clinical Hospital Number 1
City
Chita
ZIP/Postal Code
672039
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Lukyanov, MD
Phone
+7 924 277-29-71
Email
lukyanov-sergei@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

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