Status:
COMPLETED
Rhu-pGSN for Severe Covid-19 Pneumonia
Lead Sponsor:
BioAegis Therapeutics Inc.
Conditions:
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 s...
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 COVI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04358406
Start Date
July 30 2020
End Date
January 28 2022
Last Update
November 28 2023
Active Locations (3)
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1
Spitalul Clinic de Boli Infecţioase şi Pneumoftiziologie
Timișoara, Romania
2
Sant Joan de Reus SAM University Hospital
Reus, Spain
3
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain