Sars-CoV2 Clinical Trial
Official title:
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
Verified date | September 2023 |
Source | BioAegis Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 64 |
Est. completion date | January 28, 2022 |
Est. primary completion date | May 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Romania | Spitalul Clinic de Boli Infectioase si Pneumoftiziologie | Timisoara | |
Spain | Sant Joan de Reus SAM University Hospital | Reus | |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona |
Lead Sponsor | Collaborator |
---|---|
BioAegis Therapeutics Inc. |
Romania, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Safety: Number of Subjects With SAEs | Number of subjects with SAEs during the study | Day 1 through Day 90 | |
Secondary | Efficacy: All Cause Mortality Rate at Day 90 | All cause mortality rate using Kaplan-Meier survival analysis | Day 90 | |
Secondary | Safety and Tolerability: Proportion of Subjects With Adverse Events (AEs) | Proportion of subjects with adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Continuous through Day 28 | |
Secondary | Immunogenicity: Subjects With Rhu-pGSN Antibodies | Number of subjects with rhu-pGSN antibodies at Day 28 | Day 28 | |
Secondary | Efficacy: Alive Without Support at Day 90 | Number of subjects Alive without organ support at Day 90 | Day 90 | |
Secondary | Safety and Tolerability: Proportion of Subjects With Drug-related Adverse Events (AEs) | Proportion of subjects with drug-related adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Continuous through Day 14 | |
Secondary | Number of Subjects Alive Without Organ Support at Day 90 | number of subjects alive and without organ support at the Day 90 visit | Through Day 90 |
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