AzTrials
AzTrials

Severe COVID-19 PneumoniaPhase 2NCT04880694

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

A Phase 2 study testing STC3141 in people with Severe COVID-19 Pneumonia, run by Grand Medical Pty Ltd. at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe COVID-19 Pneumonia
What is being tested?
STC3141
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesBelgium
Study dates
20 May 2021to 7 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 If the subject declines to confirm consent, they will be withdrawn from the study at the point where they decline consent.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.

Who cannot join

  • 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）.
Show all 27Show fewer
  • 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.
  • Kidneys: renal impairment requiring chronic dialysis
  • Liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; the upper digestive tract hemorrhage caused by portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma.
  • Immune function: IV chemotherapy and radiotherapy within 4 weeks before screening or use of immunosuppressive medication within 2 weeks before screening including but not limited to: tacrolimus, cyclosporin, sirolimus, mycophenolate or azathioprine etc., or subjects with leukemia, lymphoma or acquired immunodeficiency syndrome [AIDS].
  • Solid organ or bone marrow transplantation within 4 weeks.
  • The following conditions occurring within 4 weeks prior to screening:
  • Acute pulmonary embolism
  • Acute coronary syndrome such as myocardial infarction, unstable angina pectoris etc.
  • Known allergy to the active ingredient of STC3141 or its excipients (i.e., phosphate buffer).
  • The investigator consider participation in the study is not in the best interests of the subjects.
  • Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the subject; affect study endpoints or decrease the chance of obtaining satisfactory data required to achieve the objectives of the study.
  • Any other severe or unstable medical condition that, in the opinion of the Investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the subject at special risk, or bias the assessment of the clinical or mental status of the subject to a significant degree.
  • Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • Onze-Lieve-Vrouwziekenhuis Aalst, VZW

    Aalst, Moorselbaan 164, 9300 Aalst

  • Universitair Ziekenhuis Brussel

    Brussels, Laarbeeklaan 101, 1090 Brussel

  • Jan Yperman Ziekenhuis vzw

    Ieper, Briekestraat 12, 8900 Ieper

  • CHU Liège

    Liège, Avenue de l'hôpital 1, 4000

Other trials in Belgium

About this study

Official title: 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

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.

Read the detailed description

Pneumonia is the most frequent and serious complication of Corona Virus Disease 2019（COVID-19）, a disease that results from severe acute respiratory syndrome coronavirus 2（SARS-CoV-2）infection with a so-called "cytokine storm", characterized by the plasma increase of many cytokines that produce long-term damage and fibrosis of lung tissue. Therefore, the development of novel therapeutic strategies to target at neutrophils associated NETs/histones may reduce the overall disease mortality rate of COVID-19.

STC3141 is a novel investigational product that can neutralize NETs/histone via charge-charge interaction. STC3141 was found to be well-tolerated in short infusions (2 hours) and continuous long-term infusions (72 hours) in healthy volunteers.

A randomized, multi-centre, phase 2a study in 25 severe COVID-19 pneumonia subjects who require hospitalization, is designed to evaluate the safety and the preliminary effect of STC3141 in this population where the treatment will be tested for the first time.

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.

The primary objective of the study is to evaluate the safety of STC3141 in subjects with severe COVID-19 pneumonia.The secondary objective is to evaluate the preliminary effects of STC3141 in the treatment of subjects with severe COVID-19 pneumonia.As an exploratory objective, the change in biomarkers from baseline following STC3141 treatment in subjects with severe COVID-19 pneumonia will be evaluated.

Being tested
STC3141
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STC3141Drug

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

    Also to receive appropriate standard of care.

  • STC3141Drug

    To receive continuous infusion of STC3141 at rate 87.5mg/hr up to 3 days (72hours).

    Also to receive appropriate standard of care.

Study groups in NCT04880694
Study groupRoleWhat they receive
Cohort 1: STC3141 58.3mg/hrExperimentalDrug: STC3141 Continuous infusion of STC3141 at rate 58.3mg/hr up to 3 days (72 hours) N=10
Receives: Drug: STC3141
Cohort 2: STC3141 87.5mg/hrExperimentalDrug: STC3141 Continuous infusion of STC3141 at rate 87.5mg/hr up to 3 days (72 hours) N=10
Receives: Drug: STC3141
Cohort 3: ComparatorNo interventionOnly to receive appropriate standard of care N=5

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 30 days

Secondary outcomes (16)

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

    Measured: through study completion, an average of 30 days.

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

    Measured: through study completion, an average of 30 days.

  3. Changes of total bleeding time（TBL）（μmol/L）

    Measured: through study completion, an average of 30 days.

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

    Measured: through study completion, an average of 30 days.

  5. Changes estimated glomerular filtration rate（eGFR）（ml/min）

    Measured: through study completion, an average of 30 days.

  6. Changes of activated partial thromboplastin time（aPTT）（seconds）

    Measured: through study completion, an average of 30 days.

  7. Changes of lactate dehydrogenase（LDH）（IU/L, or U/L, or nkat/L）

    Measured: through study completion, an average of 30 days.

  8. Changes of partial pressure of oxygen（PaO2）/fraction of inspired oxygen（FiO2） ratio

    Measured: through study completion, an average of 30 days.

  9. Changes of partial pressure of oxygen（PaO2）/fraction of inspired oxygen（FiO2） ratio for subjects who are on invasive or non-invasive ventilator

    Measured: through study completion, an average of 30 days.

  10. Changes of Sequential Organ Failure Assessment（SOFA）score

    Specific score of 0, 1, 2, 3, 4. Higher score indicates worse prognosis.

    Measured: through study completion, an average of 30 days.

  11. Time to invasive mechanical ventilation

    Measured: through study completion, an average of 30 days.

  12. Time to independence from non-invasive mechanical ventilation

    Measured: through study completion, an average of 30 days.

  13. Time to independence from oxygen therapy

    Measured: through study completion, an average of 30 days.

  14. Duration of hospitalization

    Measured: through study completion, an average of 30 days.

  15. All-cause mortality rate

    Measured: On Day 30.

  16. Subgroup analysis

    Measured: through study completion, an average of 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start20 May 2021
  3. Primary completion7 Jan 2022
  4. Study completion7 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880694
Sponsor's protocol ID
GPHIP-0202
Other IDs
2021-000399-12
Status last verified
Jun 2021
First submitted
25 Apr 2021
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STC3141 in people with Severe COVID-19 Pneumonia, run by Grand Medical Pty Ltd. at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse event（AE）, treatment emergent adverse event（TEAE）, serious adverse event（SAE）, adverse event of special interest（AESI） (time frame: up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in