Rhu-pGSN for Severe Covid-19 Pneumonia

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioAegis Therapeutics Inc.

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