Trial Outcomes & Findings for Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients (NCT NCT04780581)
NCT ID: NCT04780581
Last Updated: 2025-01-06
Results Overview
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
128 participants
Primary outcome timeframe
28 days
Results posted on
2025-01-06
Participant Flow
The sample size estimation (295 patients) for the primary outcomes was based on data from the first waves of COVID-19. Changes in pandemia status triggered to our initial estimation for sample size calculation was outdated. In addition to the high percentage of people vaccinated in Spain, in the summer of 2021 was the end of the fifth wave of COVID-19, with a very small number of patients hospitalized, so the clinical trial was premature ended in August 2021.
Randomisation was performed using a centralised, computer-generated allocation, stratified by trial site and by age under 70 years, in a 1:1 ratio. 158 patients were assessed for eligibility, and 128 were randomised: 64 to BOLUS group and 64 to RECOVERY group.
Participant milestones
| Measure |
BOLUS
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/ 24h - 3 days
|
RECOVERY
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Full Modified Intention-to-treat Anal.
STARTED
|
64
|
64
|
|
Full Modified Intention-to-treat Anal.
COMPLETED
|
63
|
62
|
|
Full Modified Intention-to-treat Anal.
NOT COMPLETED
|
1
|
2
|
|
Follow up to 28 Days (Primary End Point)
STARTED
|
63
|
62
|
|
Follow up to 28 Days (Primary End Point)
COMPLETED
|
63
|
62
|
|
Follow up to 28 Days (Primary End Point)
NOT COMPLETED
|
0
|
0
|
|
Overall Study (90 Days)
STARTED
|
63
|
62
|
|
Overall Study (90 Days)
COMPLETED
|
63
|
60
|
|
Overall Study (90 Days)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
BOLUS
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/ 24h - 3 days
|
RECOVERY
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Full Modified Intention-to-treat Anal.
Protocol Violation
|
1
|
2
|
|
Overall Study (90 Days)
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-69 years
|
40 Participants
n=63 Participants
|
42 Participants
n=62 Participants
|
82 Participants
n=125 Participants
|
|
Age, Customized
70 years and over
|
23 Participants
n=63 Participants
|
20 Participants
n=62 Participants
|
43 Participants
n=125 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=63 Participants
|
21 Participants
n=62 Participants
|
41 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=63 Participants
|
41 Participants
n=62 Participants
|
84 Participants
n=125 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Hypertension
|
31 Participants
n=63 Participants
|
22 Participants
n=62 Participants
|
53 Participants
n=125 Participants
|
|
Diabetes
|
13 Participants
n=63 Participants
|
10 Participants
n=62 Participants
|
23 Participants
n=125 Participants
|
|
Dyslipidaemia
|
16 Participants
n=63 Participants
|
22 Participants
n=62 Participants
|
38 Participants
n=125 Participants
|
|
COVID-19 characteristics
Fever
|
47 Participants
n=63 Participants
|
43 Participants
n=62 Participants
|
90 Participants
n=125 Participants
|
|
COVID-19 characteristics
Arthralgia/Myalgia
|
21 Participants
n=63 Participants
|
19 Participants
n=62 Participants
|
40 Participants
n=125 Participants
|
|
COVID-19 characteristics
Cough
|
47 Participants
n=63 Participants
|
43 Participants
n=62 Participants
|
90 Participants
n=125 Participants
|
|
COVID-19 characteristics
Thoracic pain
|
8 Participants
n=63 Participants
|
7 Participants
n=62 Participants
|
15 Participants
n=125 Participants
|
|
COVID-19 characteristics
Nausea
|
13 Participants
n=63 Participants
|
10 Participants
n=62 Participants
|
23 Participants
n=125 Participants
|
|
COVID-19 characteristics
Diarrhoea
|
18 Participants
n=63 Participants
|
16 Participants
n=62 Participants
|
34 Participants
n=125 Participants
|
|
COVID-19 characteristics
Hyposmia/hypogeusia
|
10 Participants
n=63 Participants
|
13 Participants
n=62 Participants
|
23 Participants
n=125 Participants
|
|
COVID-19 characteristics
Headache
|
15 Participants
n=63 Participants
|
9 Participants
n=62 Participants
|
24 Participants
n=125 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: This outcome, mortality rate, was evaluated 28 days after treatment (63 participants in bolus arm vs. 62 participants in recovery arm).
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Mortality Rate
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of patients who have been admitted to the ICU.
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Admission in Intensive Unit Care (ICU)
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 28 days* Proportion of patients (number of cases with respiratory support requirement / total number of patients) with non-invasive mechanical ventilation and/or high-flow oxygen requirements. * Proportion of patients (number of cases with respiratory support requirement / total number of patients) with invasive mechanical ventilation or intubation requirements.
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Evaluation of Respiratory Support Requirements
non-invasive mechanical ventilation
|
0.05 proportion of participants
|
0.03 proportion of participants
|
|
Evaluation of Respiratory Support Requirements
high-flow oxygen requirements.
|
0.10 proportion of participants
|
0.13 proportion of participants
|
|
Evaluation of Respiratory Support Requirements
invasive mechanical ventilation or intubation requirements
|
0.13 proportion of participants
|
0.12 proportion of participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of days in hospital from the star of the treatment until discharge
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Days in Hospital
|
13 Days
Standard Deviation 16
|
13 Days
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 28 daysPopulation: This adverse events related with use of high dose of glucocorticoids and were evaluated 28 days after treatment (63 participants in bolus arm vs. 62 participants in recovery arm).
Occurrence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Outcome measures
| Measure |
BOLUS
n=102 Events
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=51 Events
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Secondary infections
|
7 Events
|
8 Events
|
|
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Psychotic states
|
1 Events
|
0 Events
|
|
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Other adverse effects no related with use of high dose of glucocorticoids.
|
77 Events
|
38 Events
|
|
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Hyperglycaemia
|
17 Events
|
5 Events
|
SECONDARY outcome
Timeframe: 28 daysOccurrence of use of other immunosuppressors, if applicable
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=62 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Evaluation of Other Immunosuppressors Requirements.
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 90 daysClinical evaluation of patient status according to the WHO 10-category scale. Minimum value: 1 and maximum value: 10, higher scores mean a worse outcome.
Outcome measures
| Measure |
BOLUS
n=63 Participants
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/24h - 3 days
|
RECOVERY
n=60 Participants
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Dead (10)
|
6 participants
|
4 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Intubation PaFi<150 plus vasopressors or ECMO or Dialysis (9)
|
0 participants
|
0 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Hospitalized, NIV or high flow (6)
|
0 participants
|
0 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Hospitalized, mask or nasal prongs (5)
|
1 participants
|
0 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Hospitalized, no oxigen therapy (4)
|
2 participants
|
0 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Symptomatic, assistance needed (3)
|
0 participants
|
3 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Symptomatic, indeoendent (2)
|
12 participants
|
14 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Asymptomatic (1)
|
42 participants
|
38 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Intubation PaFi<150 or vasopressors (8)
|
0 participants
|
0 participants
|
|
Status According to the World Health Organization (WHO) 10-category Scale.
Intubation PaFi<150 (7)
|
0 participants
|
1 participants
|
Adverse Events
BOLUS
Serious events: 22 serious events
Other events: 25 other events
Deaths: 6 deaths
RECOVERY
Serious events: 21 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
BOLUS
n=63 participants at risk
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/ 24h - 3 days
|
RECOVERY
n=62 participants at risk
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
11.1%
7/63 • Number of events 7 • 90 days
|
11.3%
7/62 • Number of events 7 • 90 days
|
|
Cardiac disorders
Hypertension
|
1.6%
1/63 • Number of events 1 • 90 days
|
0.00%
0/62 • 90 days
|
|
Infections and infestations
COVID worsering
|
14.3%
9/63 • Number of events 9 • 90 days
|
14.5%
9/62 • Number of events 9 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.6%
1/63 • Number of events 1 • 90 days
|
4.8%
3/62 • Number of events 3 • 90 days
|
|
Infections and infestations
Pneumonia
|
9.5%
6/63 • Number of events 6 • 90 days
|
6.5%
4/62 • Number of events 4 • 90 days
|
|
Infections and infestations
Sepsis
|
3.2%
2/63 • Number of events 2 • 90 days
|
0.00%
0/62 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
2/63 • Number of events 2 • 90 days
|
0.00%
0/62 • 90 days
|
|
Vascular disorders
Thromboembolism
|
1.6%
1/63 • Number of events 1 • 90 days
|
4.8%
3/62 • Number of events 3 • 90 days
|
Other adverse events
| Measure |
BOLUS
n=63 participants at risk
high-dose methylprednisolone bolus (250mg/24h - 3 days)
Methylprednisolone: 250 mg/ 24h - 3 days
|
RECOVERY
n=62 participants at risk
intermediate-dose dexamethasone (6mg/24h - 10 days)
Dexamethasone: 6 mg/24h - 10 days
|
|---|---|---|
|
Endocrine disorders
Hyperglycaemia
|
23.8%
15/63 • Number of events 15 • 90 days
|
9.7%
6/62 • Number of events 6 • 90 days
|
|
Immune system disorders
Rash
|
1.6%
1/63 • Number of events 1 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/63 • Number of events 1 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Cardiac disorders
Hypertension
|
3.2%
2/63 • Number of events 2 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Cardiac disorders
Heart failure
|
1.6%
1/63 • Number of events 1 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Psychological/psychiatric disorders
|
4.8%
3/63 • Number of events 3 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Vascular disorders
Thrombotic disorders
|
1.6%
1/63 • Number of events 1 • 90 days
|
3.2%
2/62 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Tracheo-bronchitis
|
1.6%
1/63 • Number of events 1 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory function worsering
|
0.00%
0/63 • 90 days
|
1.6%
1/62 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place