Clinical trial · Interventional
Rhu-pGSN for Severe Covid-19 Pneumonia
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sars-CoV2 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Recombinant human plasma gelsolin (Rhu-pGSN) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
- interventionNames
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Rhu-pGSN
- description
- Recombinant human plasma gelsolin reconstituted for slow bolus injection.
- interventionNames
- Drug: Recombinant human plasma gelsolin (Rhu-pGSN)
Primary outcomes (2)
- measure
- Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis
- timeFrame
- Day 14
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 InvestigatorReferences
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