Rhu-pGSN for Severe Covid-19 Pneumonia

NCT04358406 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BTI-202
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Sars-CoV2

Keywords

COVID-19; Pneumonia; Severe; Cytokine storm

Outcome Measures

Primary Outcomes (2)

• 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).

  Day 14

• Safety: Number of Subjects With SAEs

  Number of subjects with SAEs during the study

  Day 1 through Day 90

Secondary Outcomes (6)

• Efficacy: All Cause Mortality Rate at Day 90

  Day 90

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

  Continuous through Day 28

• Immunogenicity: Subjects With Rhu-pGSN Antibodies

  Day 28

• Efficacy: Alive Without Support at Day 90

  Day 90

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

  Continuous through Day 14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline in matched volume to treatment arm. Undistinguishable in syringe.

Other: Placebo

Rhu-pGSN

ACTIVE COMPARATOR

Recombinant human plasma gelsolin reconstituted for slow bolus injection.

Drug: Recombinant human plasma gelsolin (Rhu-pGSN)

Interventions

Recombinant human plasma gelsolin (Rhu-pGSN) DRUG

Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses

Also known as: gelsolin

Rhu-pGSN

Placebo OTHER

Normal saline in matched volume to treatment arm. Undistinguishable in syringe.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioAegis Therapeutics Inc.: lead

Study Sites (3)

Spitalul Clinic de Boli Infecţioase şi Pneumoftiziologie

Timișoara, Romania

Location

Sant Joan de Reus SAM University Hospital

Reus, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Lymphoma, Follicular; Cytokine Release Syndrome

Interventions

Gelsolin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Microfilament Proteins; Biopolymers; Polymers; Macromolecular Substances; Intracellular Calcium-Sensing Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Cytoskeletal Proteins

Results Point of Contact

• Title: Mark J. DiNubile, MD
• Organization: BioAegis Therapeutics Inc.

mdinubile@bioaegistx.com

609-706-5866

Study Officials

• Mark J DiNubile, MD

  BioAegis Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment blinded to all but unblinded pharmacist
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, placebo controlled interventional

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: July 30, 2020
• Primary Completion: May 25, 2021
• Study Completion: January 28, 2022
• Last Updated: November 28, 2023
• Results First Posted: February 9, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); RO (1)