Trial Outcomes & Findings for Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome (NCT NCT00128180)

NCT ID: NCT00128180

Last Updated: 2014-12-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2014-12-24

Participant Flow

Participant milestones

Measure	Active Active drug	Placebo Placebo group
Overall Study STARTED	32	34
Overall Study COMPLETED	32	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome

Baseline characteristics by cohort

Measure	Active n=32 Participants Active drug	Placebo n=34 Participants Placebo group	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	40.94 years STANDARD_DEVIATION 15.49 • n=5 Participants	36.26 years STANDARD_DEVIATION 15.13 • n=7 Participants	38.53 years STANDARD_DEVIATION 15.37 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Chile	32 participants n=5 Participants	34 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol, the efficacy analysis was limited to participants with confirmed hantavirus infection.

Outcome measures

Measure	Active n=30 Participants Active drug	Placebo n=30 Participants Placebo group
The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation	0.27 proportion of paticipants Interval 0.12 to 0.46	0.47 proportion of paticipants Interval 0.28 to 0.65

PRIMARY outcome

Timeframe: 6 months

Population: Per protocol, safety analysis inluded all participants, including those where hantavirus infection was not confirmed.

The Number of participants with SAEs

Outcome measures

Measure	Active n=32 Participants Active drug	Placebo n=34 Participants Placebo group
Number of Participants With SAEs	14 participants	25 participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.

number of participants

Outcome measures

Measure	Active n=30 Participants Active drug	Placebo n=30 Participants Placebo group
Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection, and this analysis was limited to those who were admitted to ICU. Four subjects with confirmed hantavirus infection were not admitted to ICU.

Outcome measures

Measure	Active n=27 Participants Active drug	Placebo n=29 Participants Placebo group
Duration of ICU Stays	4.48 days Standard Deviation 2.78	5.83 days Standard Deviation 4.43

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.

Days

Outcome measures

Measure	Active n=30 Participants Active drug	Placebo n=30 Participants Placebo group
Duration of Hospital Stay in Days	8.90 days Standard Deviation 6.08	10.67 days Standard Deviation 8.93

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.

Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.

Outcome measures

Measure	Active n=30 Participants Active drug	Placebo n=30 Participants Placebo group
Duration of Shock and/or Pressor/Inotropic Support	2.67 days Standard Deviation 2.10	3.75 days Standard Deviation 3.23

SECONDARY outcome

Timeframe: 6 months

Population: This efficacy this analysis was limited to participants with confirmed hantavirus infection who were not already intubated at study entry.

Participants

Outcome measures

Measure	Active n=26 Participants Active drug	Placebo n=20 Participants Placebo group
Number of Participants Intubated and Placed on a Ventilator After Study Entry.	6 participants	10 participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, this efficacy analysis was limited to participants with confirmed hantavirus infection who were not already in shock at study entry.

Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.

Outcome measures

Measure	Active n=21 Participants Active drug	Placebo n=15 Participants Placebo group
Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry	4 participants	6 participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol this efficacy analysis was limited to participants with confirmed hantavirus infection who were intubated and on a ventillator.

Outcome measures

Measure	Active n=11 Participants Active drug	Placebo n=20 Participants Placebo group
Length of Time on a Ventilator	2.64 days Standard Deviation 2.06	4.95 days Standard Deviation 4.48

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol, this efficay analysis was limited to participants with confirmed hantavirus infection who did not have a serum creatinine equal or greater to 3.0 mg/dL at entry.

Outcome measures

Measure	Active n=29 Participants Active drug	Placebo n=30 Participants Placebo group
Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry	1 participants	6 participants

Adverse Events

Active

Serious events: 14 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 25 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active n=32 participants at risk Active drug	Placebo n=34 participants at risk Placebo group
Blood and lymphatic system disorders Blood and lymphatic	0.00% 0/32 • 12 weeks	5.9% 2/34 • Number of events 2 • 12 weeks
Cardiac disorders Cardiac disorder	21.9% 7/32 • Number of events 7 • 12 weeks	55.9% 19/34 • Number of events 19 • 12 weeks
Hepatobiliary disorders Hepatobiliary disorders	34.4% 11/32 • Number of events 11 • 12 weeks	44.1% 15/34 • Number of events 15 • 12 weeks
Metabolism and nutrition disorders Metabolism and nutrition disorders	3.1% 1/32 • Number of events 1 • 12 weeks	5.9% 2/34 • Number of events 2 • 12 weeks
Nervous system disorders Nervous system disorders	3.1% 1/32 • Number of events 1 • 12 weeks	2.9% 1/34 • Number of events 1 • 12 weeks
Renal and urinary disorders Renal and urinary disorders	0.00% 0/32 • 12 weeks	11.8% 4/34 • Number of events 4 • 12 weeks
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	6.2% 2/32 • Number of events 2 • 12 weeks	14.7% 5/34 • Number of events 5 • 12 weeks

Other adverse events

Measure	Active n=32 participants at risk Active drug	Placebo n=34 participants at risk Placebo group
Eye disorders Eye Disorder	0.00% 0/32 • 12 weeks	2.9% 1/34 • Number of events 1 • 12 weeks
Gastrointestinal disorders Gastrointestinal Disorder	31.2% 10/32 • Number of events 10 • 12 weeks	47.1% 16/34 • Number of events 16 • 12 weeks
General disorders General disorders	9.4% 3/32 • Number of events 3 • 12 weeks	23.5% 8/34 • Number of events 8 • 12 weeks
Ear and labyrinth disorders Head, Ears, Nose, Throat	3.1% 1/32 • Number of events 1 • 12 weeks	2.9% 1/34 • Number of events 1 • 12 weeks
Infections and infestations Infections and	0.00% 0/32 • 12 weeks	8.8% 3/34 • Number of events 3 • 12 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal, connective tissue and bone disord	3.1% 1/32 • Number of events 1 • 12 weeks	5.9% 2/34 • Number of events 2 • 12 weeks
Psychiatric disorders Psychiatric Disorder	0.00% 0/32 • 12 weeks	5.9% 2/34 • Number of events 2 • 12 weeks
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	9.4% 3/32 • Number of events 3 • 12 weeks	11.8% 4/34 • Number of events 4 • 12 weeks
Vascular disorders Vascular disorders	3.1% 1/32 • Number of events 1 • 12 weeks	5.9% 2/34 • Number of events 2 • 12 weeks

Additional Information

Gregory Mertz, MD

UNewMexico

Phone: 5059808601

Email: gmertz@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place