Phase 2
N=64
Rhu-pGSN for Severe Covid-19 Pneumonia
Sars-CoV2
Bottom Line
View on ClinicalTrials.gov: NCT04358406 ↗Enrolled (actual)
64
Serious AEs
21.3%
Results posted
Feb 2023
Primary outcome: Primary: Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis — 27; 25 participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant human plasma gelsolin (Rhu-pGSN) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioAegis Therapeutics Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis |
27; 25 | >0.05 |
| PRIMARY Safety: Number of Subjects With SAEs |
8; 5 | — |
| SECONDARY Efficacy: All Cause Mortality Rate at Day 90 |
2; 2 | — |
| SECONDARY Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs) |
16; 16 | — |
| SECONDARY Immunogenicity: Subjects With Rhu-pGSN Antibodies |
7; 7 | — |
| SECONDARY Efficacy: Alive Without Support at Day 90 |
28; 25 | — |
| SECONDARY Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs) |
0; 1 | — |
| SECONDARY Number of Subjects Alive Without Organ Support at Day 90 |
28; 25 | — |
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
Eligibility Criteria
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
- Informed consent 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 childbearing potential must agree to use 2 medically accepted birth control 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
- 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 life expectancy <6 months unrelated to acute COVID infection in the opinion of the Investigator
Data sourced from ClinicalTrials.gov (NCT04358406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.