A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019（COVID-19）Pneumonia

NCT04880694 | Completed Phase 2 DMC

• 2 other identifiers: GPHIP-02022021-000399-12
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

The study is a Randomized, Open-Label, Multi-Centre, Phase 2a Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects with Severe Corona Virus Disease 2019（COVID-19）Pneumonia.

Conditions

Severe COVID-19 Pneumonia

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse event（AE）, treatment emergent adverse event（TEAE）, serious adverse event（SAE）, adverse event of special interest（AESI）

  up to 30 days

Secondary Outcomes (16)

• Changes of C-reactive protein（CRP）（mg/dL, or nmol/L, or mg/L）

  through study completion, an average of 30 days.

• Changes of D-dimer（mg/L, or ng/mL, or μg/mL）

  through study completion, an average of 30 days.

• Changes of total bleeding time（TBL）（μmol/L）

  through study completion, an average of 30 days.

• Changes alanine transaminase（ALT）（IU/L, or U/L, or nkat/L）

  through study completion, an average of 30 days.

• Changes estimated glomerular filtration rate（eGFR）（ml/min）

  through study completion, an average of 30 days.

Other Outcomes (2)

• Changes from baseline in MPO（neutrophil-derived extracellular traps (NETs)）（ng/ml）and citrullinated histone (H3 in plasma)（ng/ml）

  up to 7 days

• Changes from baseline in interleukin（IL）-1b, interleukin（IL）-2, interleukin（IL）-6, interleukin（IL）-8/CXCL8, interleukin（IL）-10, Interferon（IFN）-γ, tumor necrosis factor（TNF）-α, interleukin（IL）-12/P70（pg/ml）

  up to 7 days

Study Arms (3)

Cohort 1: STC3141 58.3mg/hr

EXPERIMENTAL

Drug: STC3141 Continuous infusion of STC3141 at rate 58.3mg/hr up to 3 days (72 hours) N=10

Drug: STC3141

Cohort 2: STC3141 87.5mg/hr

EXPERIMENTAL

Drug: STC3141 Continuous infusion of STC3141 at rate 87.5mg/hr up to 3 days (72 hours) N=10

Drug: STC3141

Cohort 3: Comparator

NO INTERVENTION

Only to receive appropriate standard of care N=5

Interventions

STC3141 DRUG

To receive continuous infusion of STC3141 at rate 58.3mg/hr up to 3 days (72hours). Also to receive appropriate standard of care.

Cohort 1: STC3141 58.3mg/hr

Eligibility Criteria

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

You may qualify if:

• Males and non-pregnant females who are 18 years or older (inclusive).
• Signed informed consent. Subjects are to provide informed consent prior to any study procedures being performed. Consent can be oral if a written consent cannot be expressed. Where it is not practicable to approach a subject highly dependent on medical care, or the subject is not capable of making such a decision, consent will be sought from the legal representative of the subject. Subjects enrolled in the study based on consent by the legal representative will be given the opportunity to provide written confirmatory consent when and if they become able to do so. If the subject declines to confirm consent, they will be withdrawn from the study at the point where they decline consent.
• Virological diagnosis of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2）infection (documentation of real-time polymerase chain reaction（PCR）or equivalent within the last 72h positive results is available before screening)
• Hospitalized due to clinical/chest image diagnosis of sever pneumonia. Severe pneumonia defined as dyspnea, hemoglobin oxygen saturation（SpO2）on room air at rest ≤93% or Partial pressure of oxygen（PaO2）/Fraction of inspired oxygen（FiO2）\<300 mmHg.

You may not qualify if:

• Subjects who have renal impairment at screening, defined as an estimate glomerular filtration rate (eGFR) \<55 ml/min/Body Surface area（BSA）
• Subjects requiring extracorporeal membrane oxygenation (ECMO) at screening
• Subjects who are on invasive mechanical ventilator more than 24 hours
• Female subjects of child-bearing potential (as judged by the Investigator) who do not agree to remain abstinent or use medically acceptable methods of contraception (e.g., implants, injectable, combined oral contraceptives, intra-uterine devices \[Intrauterine devices（IUDs）\], double-barrier protection) during the study. Male participants who do not agree to use a condom with spermicide during intercourse (if not surgically sterilized) during the study.
• Subjects who receive anticoagulants overall (except subtherapeutic doses of heparin which is ≤ 6000 International Unit（IU）twice a day Enoxaparin or equivalence) including but not limited to warfarin, rivaroxaban, apixaban, dabigatran acenocoumarol, fencoumarol, or other parenteral anticoagulants at randomization. Antiplatelets drugs are allowed
• Subjects who have International Normalized ratio or International normalized ratio（INR）\>1.3 Upper limit of normal（ULN）.
• Subjects who have Absolute Neutrophil Count (ANC) \<1,000/μL.
• Subjects who have platelets count \<80,000 /μL.
• Subjects who have activated Partial Thromboplastin Time (aPTT) \>1.5 Upper limit of normal（ULN）.
• Severe anaemia (haemoglobin \< 7.0 g/dL).
• Bleeding in the past 24 hours requiring blood transfusion.
• Women who are pregnant or lactating at Screening or planning to conceive (self or partner) at any time during the study, including the follow-up period.
• Subjects who have the following chronic organ dysfunction or immunosuppression:
• Heart: New York heart association cardiac function IV.
• Lung: severe lung diseases other than COVID-19 lead to home oxygen therapy.

Sponsors & Collaborators

• Grand Medical Pty Ltd.: lead
• Trium Clinical Consulting: collaborator

Study Sites (4)

Onze-Lieve-Vrouwziekenhuis Aalst, VZW

Aalst, Moorselbaan 164, 9300 Aalst, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Laarbeeklaan 101, 1090 Brussel, Belgium

Location

Jan Yperman Ziekenhuis vzw

Ieper, Briekestraat 12, 8900 Ieper, Belgium

Location

CHU Liège

Liège, Avenue de l'hôpital 1, 4000, Belgium

Location

MeSH Terms

Conditions

COVID-19

Interventions

STC3141

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James Pang, PhD

  Grand Medical Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to three cohorts in a 2:2:1 ratio to receive continuous infusion of STC3141 either at rate 58.3mg/hr or 87.5mg/hr up to 3 days (72hours), or to receive appropriate standard of care. All subjects in STC3141 treatment groups will also receive standard of care for their conditions as background treatment.

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 11, 2021
• Study Start: May 20, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: April 8, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)