CompletedNCT04358406Updated Nov 28, 2023Results posted

Rhu-pGSN for Severe Covid-19 Pneumonia

A Phase 2 interventional study of Recombinant human plasma gelsolin (Rhu-pGSN) and Placebo in Sars-CoV2, sponsored by BioAegis Therapeutics Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by BioAegis Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Study Objectives:

Primary

To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or 6 on the World Health Organization (WHO) 9-point severity scale
To evaluate the safety and tolerability of three IV doses of rhu-pGSN administered to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5, or 6 on the WHO 9-point severity scale

Secondary

To further assess the efficacy of IV administered rhu-pGSN
To assess changes in WHO 9-point severity score for SOC with or without rhu-pGSN
To evaluate the effect of administered rhu-pGSN on survival rates
To assess the relationship of pGSN levels (and other biomarkers) at baseline with clinical outcomes
[OPTIONAL] To follow the pharmacokinetics (PK) of administered rhu-pGSN

Immunogenicity

To investigate the development of antibodies against rhu-pGSN post-treatment

Read the detailed description

Efficacy and safety of IV rhu-pGSN on top of SOC will be evaluated initially in 60 participants representative of the drug target population: high-risk subjects with acute severe pneumonia due to COVID-19. The rhu-pGSN dose will be based on actual body weight given at 12 mg/kg. Three doses will be given at 0, 12 and 24 hours intervals promptly after enrollment by IV infusion through a 0.2 µm filter. Participants will be randomized 1:1 rhu-pGSN or placebo. Interim safety analyses will be conducted after enrollment of 12, 24, 36, and 48 patients.

The primary efficacy outcome will be the proportion of patients surviving on Day 14 without mechanical ventilation, vasopressors or dialysis. Secondary efficacy outcomes will include: daily change in 9-point WHO severity score through at least Day 14; all-cause mortality at Days 28 and 90; time to death (Kaplan-Meier survival analysis); proportion of subjects alive on Days 7, 28, 60, and 90 without: ongoing use of vasopressors, ongoing intubation/mechanical ventilation, ongoing residence in an intensive care unit (ICU), new ongoing need for dialysis/renal replacement therapy; proportion of subjects discharged to home or immediate prior residence by Day 28; days on the ventilator; length of stay in hospital and in ICU and re-admission to an acute-care hospital up to Day 90. Safety of administration of rhu-pGSN at the indicated dosage will also be evaluated.

Baseline and sequential levels of pGSN and inflammatory biomarkers will be measured. On days 1, 28, and 90, immunogenicity due to the formation of anti-pGSN antibodies will be assessed.

Conditions studied

Sars-CoV2

Browse trials for

Keywords

COVID-19
Pneumonia
Severe
Cytokine storm

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 64 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

BioAegis Therapeutics Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hospitalized with laboratory-confirmed (RT-PCR+) or highly suspected (compatible with at least bilobar lung involvement without another plausible diagnosis) COVID-19
Weight ≤100 kg
Within 24 hours of reaching a WHO severity score of 4-6 either:
- At admission
- While already hospitalized
obtained from subject/next of kin/legal proxy
Primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on chest radiograph or CT as assessed by the admitting emergency-department (ED), clinic, or ward physician or equivalent caregiver
Recommended (not mandatory) guidance/discretionary criteria defining patients with pneumonia satisfying all 4 categories below:
- At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, or chest pain
- At least 2 vital sign abnormalities: fever, tachycardia, or tachypnea (thresholds -- fever: oral or core temperature >100.4 °F [38 °C]; heart rate >100 beats/min; respiratory rate >24/min)
- At least one finding of other clinical signs and laboratory abnormalities: hypoxemia (O2 saturation \<90%), clinical evidence of pulmonary consolidation, or leukocytosis or leukopenia
- Chest imaging or CT showing new (or presumed new or worsening) pulmonary infiltrates
  - Principal investigator to note radiologic findings in the electronic case report form (eCRF)
  - Radiology report to be placed in the eCRF
  - A copy of the radiograph attached to be saved for review
A hyperinflammatory status (defined by increased ferritin ≥500 µg/L, D-dimer ≥1000 ng/mL, or C-reactive protein (CRP) ≥75 mg/L)
During the course of the study starting at screening and for at least 6 months after their final study treatment:
- Female subjects of must agree to use 2 medically accepted methods
- Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner
- All subjects must agree not to donate sperm or eggs (ovocytes)

Exclusion criteria

Exclusion Criteria:

A negative RT-PCR test for COVID-19 during the evaluation of the present illness
Extracorporeal membrane oxygenation (ECMO)
Pregnant or lactating women
Active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days
Transplantation of hematopoietic or solid organs
Chronic mechanical ventilation or dialysis
Otherwise unsuitable for study participation because of chronic, severe, end-stage, and life-limiting underlying disease unrelated to COVID-19 likely to interfere with management and assessment of acute pneumonia, only comfort or limited (non-aggressive) care is to be given, or \<6 months unrelated to acute COVID infection in the opinion of the Investigator

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 64 participants (actual)

Study arms

Placebo comparator
Placebo
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
Other: Placebo
Active comparator
Rhu-pGSN
Recombinant human plasma gelsolin reconstituted for slow bolus injection.
Drug: Recombinant human plasma gelsolin (Rhu-pGSN)

Interventions

DrugRecombinant human plasma gelsolin (Rhu-pGSN)
Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
Also known as: gelsolin
OtherPlacebo
Normal saline in matched volume to treatment arm. Undistinguishable in syringe.

What researchers measure

Primary outcomes

Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis
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).
Time frame: Day 14
Safety: Number of Subjects With SAEs
Number of subjects with SAEs during the study
Time frame: Day 1 through Day 90

Secondary outcomes

Efficacy: All Cause Mortality Rate at Day 90
All cause mortality rate using Kaplan-Meier survival analysis
Time frame: Day 90
Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs)
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
Time frame: Continuous through Day 28
Immunogenicity: Subjects With Rhu-pGSN Antibodies
Number of subjects with rhu-pGSN antibodies at Day 28
Time frame: Day 28
Efficacy: Alive Without Support at Day 90
Number of subjects Alive without organ support at Day 90
Time frame: Day 90
Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs)
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
Time frame: Continuous through Day 14
Number of Subjects Alive Without Organ Support at Day 90
number of subjects alive and without organ support at the Day 90 visit
Time frame: Through Day 90

Results

Posted Feb 9, 2023

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Rhu-pGSN
Started	33	31
Randomized	33	31
Treated	31	30
Completed	27	27
Not completed	6	4

Outcome measures

PrimaryEfficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis

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).

Time frame:: Day 14
Reported as:: Number · participants

Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis
participants	Placebo	Rhu-pGSN
Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis	27	25

Statistical analysis

Placebo vs Rhu-pGSN · Cochran-Mantel-Haenszel · p = >0.05
Placebo vs Rhu-pGSN · Chi-squared · p = >0.1

PrimarySafety: Number of Subjects With SAEs

Number of subjects with SAEs during the study

Time frame:: Day 1 through Day 90
Reported as:: Number · participants

Safety: Number of Subjects With SAEs
participants	Placebo	Rhu-pGSN
Safety: Number of Subjects With SAEs	8	5

SecondaryEfficacy: All Cause Mortality Rate at Day 90

All cause mortality rate using Kaplan-Meier survival analysis

Time frame:: Day 90
Reported as:: Number · participants

Efficacy: All Cause Mortality Rate at Day 90
participants	Placebo	Rhu-pGSN
Efficacy: All Cause Mortality Rate at Day 90	2	2

SecondarySafety and Tolerability: Proportion of Subjects With Adverse Events (AEs)

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

Time frame:: Continuous through Day 28
Reported as:: Count of participants · Participants

Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs)
Participants	Placebo	Rhu-pGSN
Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs)	16	16

SecondaryImmunogenicity: Subjects With Rhu-pGSN Antibodies

Number of subjects with rhu-pGSN antibodies at Day 28

Time frame:: Day 28
Reported as:: Number · participants with anti-drug antibodies

Immunogenicity: Subjects With Rhu-pGSN Antibodies
participants with anti-drug antibodies	Placebo	Rhu-pGSN
Immunogenicity: Subjects With Rhu-pGSN Antibodies	7	7

SecondaryEfficacy: Alive Without Support at Day 90

Number of subjects Alive without organ support at Day 90

Time frame:: Day 90
Reported as:: Number · participants

Efficacy: Alive Without Support at Day 90
participants	Placebo	Rhu-pGSN
Efficacy: Alive Without Support at Day 90	28	25

SecondarySafety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs)

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

Time frame:: Continuous through Day 14
Reported as:: Count of participants · Participants

Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs)
Participants	Placebo	Rhu-pGSN
Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs)	0	1

SecondaryNumber of Subjects Alive Without Organ Support at Day 90

number of subjects alive and without organ support at the Day 90 visit

Time frame:: Through Day 90
Reported as:: Count of participants · Participants

Number of Subjects Alive Without Organ Support at Day 90
Participants	Placebo	Rhu-pGSN
Number of Subjects Alive Without Organ Support at Day 90	28	25

Adverse events

Collected over Entire 90 day study period. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	2/31 (6.5%)	8/31 (25.8%)	16/31 (51.6%)
Rhu-pGSN	2/30 (6.7%)	5/30 (16.7%)	16/30 (53.3%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Placebo	Rhu-pGSN
Severe acute respiratory syndromeInfections and infestations	2/31	2/30
Acute Respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	2/31	2/30
COVID 19 PneumoniaInfections and infestations	1/31	1/30
PneumoniaInfections and infestations	1/31	1/30
Pneumonia bacterialInfections and infestations	0/31	1/30
DiarrhoeaEye disorders	0/31	1/30
DeathGeneral disorders	0/31	1/30
HypokalemiaMetabolism and nutrition disorders	0/31	1/30
Cerebrovascular AccidentNervous system disorders	0/31	1/30
COVID 19Infections and infestations	1/31	0/30

Most frequent other events

Most frequent other events
Event	Placebo	Rhu-pGSN
HyperglycemiaMetabolism and nutrition disorders	4/31	3/30
Transaminase IncreaseInvestigations	0/31	3/30
ConstipationGastrointestinal disorders	3/31	3/30
AnaemiaBlood and lymphatic system disorders	2/31	3/30
HypertensionVascular disorders	3/31	1/30
SARS COV2Infections and infestations	2/31	2/30
COVID 19Infections and infestations	1/31	2/30
Acute Respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	2/31	2/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Rhu-pGSN	Total
Median	64 (36 to 78)	64 (34 to 80)	64 (34 to 80)

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Rhu-pGSN	Total
Female	12	14	26
Male	19	16	35

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Rhu-pGSN	Total
American Indian or Alaska Native	1	0	1
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	3	5
White	28	27	55
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Placebo	Rhu-pGSN	Total
Romania	2	1	3
Spain	29	29	58

World Health Organization (WHO) Severity Scale
World Health Organization (WHO) Severity Scale(Participants)	Placebo	Rhu-pGSN	Total
WHO Severity 4: Oxygen by Mask or Nasal Cannula; Less severe than WHO 5.	27	27	54
WHO Severity 5: Noninvasive ventilation (CPAP or BiPAP) or high-flow oxygen; More severe than WHO 4	4	3	7

Study locations

3 sites

Spitalul Clinic de Boli Infecţioase şi Pneumoftiziologie
Timişoara, Romania
Sant Joan de Reus SAM University Hospital
Reus, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain

References and documents

Study documents

Study protocol ↗ · Jun 9, 2021
Statistical analysis plan ↗ · Jun 29, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in May 2021, 9 months.

Results were first posted in Feb 2023, 1 year 8 months after primary completion.

Of 223 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's 9 months is above that.

Counting every sponsor, half of 582 studies reached it within 9 months; a quarter within 5 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 16, 2020
First posted: Apr 24, 2020
StartActual: Jul 30, 2020
Primary completionActual: May 25, 2021
CompletionActual: Jan 28, 2022
Results first posted: Feb 9, 2023
Last update: Nov 28, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04358406
Lead sponsor: BioAegis Therapeutics Inc.
Responsible party: Sponsor
First posted: Apr 24, 2020
Start date: Jul 30, 2020
Primary completion: May 25, 2021
Completion: Jan 28, 2022
Results posted: Feb 9, 2023
Last update: Nov 28, 2023

Study contacts

Mark J DiNubile, MD

study director · BioAegis Therapeutics Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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