Trial Outcomes & Findings for SPI-1005 Treatment in Severe COVID-19 Patients (NCT NCT04483973)
NCT ID: NCT04483973
Last Updated: 2026-06-29
Results Overview
Number of participants with adverse events, categorized by Common Terminology Criteria for Adverse Events (CTCAE) grading for severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
30 days
Results posted on
2026-06-29
Participant Flow
Participant milestones
| Measure |
Placebo
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Overall Study
Death
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Subject non-compliant with study drug dosing
|
0
|
1
|
Baseline Characteristics
SPI-1005 Treatment in Severe COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=16 Participants
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 16.7 • n=9 Participants
|
54.8 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
55.8 years
STANDARD_DEVIATION 13.9 • n=267 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
16 participants
n=27 Participants
|
25 participants
n=267 Participants
|
|
COVID-19 Vaccination
Yes
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
COVID-19 Vaccination
No
|
5 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
WHO Ordinal Scale
|
5.44 units on a scale
STANDARD_DEVIATION 0.73 • n=9 Participants
|
5.44 units on a scale
STANDARD_DEVIATION 0.63 • n=27 Participants
|
5.44 units on a scale
STANDARD_DEVIATION 0.65 • n=267 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of participants with adverse events, categorized by Common Terminology Criteria for Adverse Events (CTCAE) grading for severity.
Outcome measures
| Measure |
Placebo
n=9 Participants
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=16 Participants
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events
Grade 1 (Mild)
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment-related Adverse Events
Grade 2 (Moderate)
|
4 participants
|
10 participants
|
|
Number of Participants With Treatment-related Adverse Events
Grade 3 (Severe)
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-related Adverse Events
Grade 4 (Life-Threatening)
|
2 participants
|
4 participants
|
|
Number of Participants With Treatment-related Adverse Events
Grade 5 (Death)
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 30 daysClinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Outcome measures
| Measure |
Placebo
n=6 Participants
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=11 Participants
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
WHO Ordinal Scale
|
2.33 units on a scale
Standard Deviation 2.42
|
2.64 units on a scale
Standard Deviation 2.01
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
SPI-1005 400 mg BID
Serious events: 5 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=16 participants at risk
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
0.00%
0/16 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
0.00%
0/16 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
0.00%
0/16 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Vascular disorders
Haematoma
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
0.00%
0/16 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
18.8%
3/16 • Number of events 3 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
6.2%
1/16 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=16 participants at risk
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/9 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
12.5%
2/16 • Number of events 2 • 30 days, and up to 60 days for subjects who do not show resolution of clinical status and/or laboratory results on Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60