Trial Outcomes & Findings for Rhu-pGSN for Severe Covid-19 Pneumonia (NCT NCT04358406)
NCT ID: NCT04358406
Last Updated: 2023-11-28
Results Overview
Number and percentage of subjects alive on Day 14 without ongoing use of vasopressors, ongoing intubation/mechanical ventilation, or new/ongoing need for dialysis/RRT. Subjects who discontinued from the study early or whose survival status was inconclusive on Day 14 were considered as a failure (Not Alive).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Day 14
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Placebo
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
Randomized
|
33
|
31
|
|
Overall Study
Treated
|
31
|
30
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rhu-pGSN for Severe Covid-19 Pneumonia
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
World Health Organization (WHO) Severity Scale
WHO Severity 4: Oxygen by Mask or Nasal Cannula; Less severe than WHO 5.
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
World Health Organization (WHO) Severity Scale
WHO Severity 5: Noninvasive ventilation (CPAP or BiPAP) or high-flow oxygen; More severe than WHO 4
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Full Analysis Set: All randomized and treated with at least 1 dose of study therapy
Number and percentage of subjects alive on Day 14 without ongoing use of vasopressors, ongoing intubation/mechanical ventilation, or new/ongoing need for dialysis/RRT. Subjects who discontinued from the study early or whose survival status was inconclusive on Day 14 were considered as a failure (Not Alive).
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis
|
27 participants
|
25 participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 90Population: Full Analysis Set: All randomized and treated with at least 1 dose of study therapy
Number of subjects with SAEs during the study
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Safety: Number of Subjects With SAEs
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 90Population: Full Analysis Set: All randomized and treated with at least 1 dose of study drug
All cause mortality rate using Kaplan-Meier survival analysis
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Efficacy: All Cause Mortality Rate at Day 90
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Continuous through Day 28Population: Full Analysis Set (all randomized and treated (At least 1 dose) subjects
Proportion of subjects with adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs)
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full analysis set (not all tested for anti-drug antibodies at all time points on days 1, 28, and 90)
Number of subjects with rhu-pGSN antibodies at Day 28
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Immunogenicity: Subjects With Rhu-pGSN Antibodies
|
7 participants with anti-drug antibodies
|
7 participants with anti-drug antibodies
|
SECONDARY outcome
Timeframe: Day 90Population: Full Analysis Set: All randomized and treated with at least 1 dose of study drug
Number of subjects Alive without organ support at Day 90
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Efficacy: Alive Without Support at Day 90
|
28 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Continuous through Day 14Population: Full Analysis Set (all randomized and treated (At least 1 dose) subjects
Proportion of subjects with drug-related adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through Day 90Population: full analysis set (all treated subjects)
number of subjects alive and without organ support at the Day 90 visit
Outcome measures
| Measure |
Placebo
n=31 Participants
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 Participants
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Number of Subjects Alive Without Organ Support at Day 90
|
28 Participants
|
25 Participants
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 16 other events
Deaths: 2 deaths
Rhu-pGSN
Serious events: 5 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 participants at risk
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Infections and infestations
Severe acute respiratory syndrome
|
6.5%
2/31 • Entire 90 day study period
|
6.7%
2/30 • Entire 90 day study period
|
|
Infections and infestations
COVID 19 Pneumonia
|
3.2%
1/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Infections and infestations
COVID 19
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Infections and infestations
Septic shock
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
|
Infections and infestations
Superinfection bacterial
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory distress syndrome
|
6.5%
2/31 • Entire 90 day study period
|
6.7%
2/30 • Entire 90 day study period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
|
Eye disorders
Diarrhoea
|
0.00%
0/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
General disorders
Death
|
0.00%
0/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Investigations
Oxygen Saturation Decreased
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Vascular disorders
Hemodynamic instability
|
3.2%
1/31 • Entire 90 day study period
|
0.00%
0/30 • Entire 90 day study period
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Placebo: Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
|
Rhu-pGSN
n=30 participants at risk
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Recombinant human plasma gelsolin (Rhu-pGSN): Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
|
|---|---|---|
|
Infections and infestations
SARS COV2
|
6.5%
2/31 • Entire 90 day study period
|
6.7%
2/30 • Entire 90 day study period
|
|
Infections and infestations
COVID 19
|
3.2%
1/31 • Entire 90 day study period
|
6.7%
2/30 • Entire 90 day study period
|
|
Investigations
Transaminase Increase
|
0.00%
0/31 • Entire 90 day study period
|
10.0%
3/30 • Entire 90 day study period
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.9%
4/31 • Entire 90 day study period
|
10.0%
3/30 • Entire 90 day study period
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Entire 90 day study period
|
10.0%
3/30 • Entire 90 day study period
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
2/31 • Entire 90 day study period
|
10.0%
3/30 • Entire 90 day study period
|
|
Vascular disorders
Hypertension
|
9.7%
3/31 • Entire 90 day study period
|
3.3%
1/30 • Entire 90 day study period
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory distress syndrome
|
6.5%
2/31 • Entire 90 day study period
|
6.7%
2/30 • Entire 90 day study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place