COVID19 PneumoniaPhase 2NCT04565379
Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
A Phase 2 study testing NuSepin® 0.1 mg and NuSepin® 0.2 mg in people with COVID19 Pneumonia, run by Shaperon at 5 sites in Romania.
Trial summary
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- COVID19 Pneumonia
- What is being tested?
- NuSepin® 0.1 mg and NuSepin® 0.2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesRomania
- Study dates
- 24 Sep 2020to 13 Apr 2021
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged between 18≤ and <80 years old
- Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization
- Diagnosis of pneumonia based on:
- Radiographic infiltrates by imaging (chest x-ray, CT scan) AND
- 3 of the following clinical symptoms: new onset cough, fever, fatigue, sputum (all day), tachypnea, dyspnea, pleuritic chest pain AND
- CRP value > 10 mg/L
Show all 12Show fewer
- Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109
- L
- Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio < 300mgHg at screening
- Patients capable to give consent and who have signed the informed consent form before any trial related assessment.
- Medically accepted effective contraception for women of childbearing potential (WOCBP) which should be continued until at least 90 days after the last dose of trial treatment.
- Patients with NEWS2 score > 7
Who cannot join
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Reduced renal function with estimated glomerular filtration rate (eGFR) < 30 ml/min or hemodialysis or hemofiltration.
- Pregnancy or breast feeding.
- Evidence of multiorgan failure
- Steroid treatment by any reason within 72 hours prior to enrolment
- Participation in any other clinical trial of an experimental agent treatment for COVID-19
- Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Romania5 sites
"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
Cluj-Napoca
Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
Craiova
"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
Iași
Ramnicu Sarat Clinical Hospital
Râmnicu Sărat, 125300
"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
Suceava
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Phase 2 Clinical Trial to Investigate the Efficacy and Safety of 2 Doses of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients
- Conditions
- COVID19 Pneumonia
- Being tested
- NuSepin® 0.1 mg, NuSepin® 0.2 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuSepin® 0.1 mgDrug
NuSepin® 0.1 mg
NuSepin® 0.2 mgDrug
NuSepin® 0.2 mg
PlaceboDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| NuSepin® 0.1 mg | Active comparator | NuSepin® 0.1 mg/kg in 100 ml normal saline infusion Receives: Drug: NuSepin® 0.1 mg |
| NuSepin® 0.2 mg | Active comparator | NuSepin® 0.2 mg/kg in 100 ml normal saline infusion Receives: Drug: NuSepin® 0.2 mg |
| Placebo | Placebo comparator | 100 ml normal saline infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Measured: Day 29
Secondary outcomes (10)
Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline
Measured: Day 15 and Day 29
Clinical Status assessed by the six-category ordinal scale at fixed time points
Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status \& outcome
Measured: Day 1, 4, 9, 15 and 29
Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours
Measured: Up to Day 29
All-cause mortality
Measured: Up to Day 29
Duration (days) of mechanical ventilation
Measured: Up to Day 29
Duration (days) of extracorporeal membrane oxygenation
Measured: Up to Day 29
Duration (days) of supplemental oxygenation
Measured: Up to Day 29
Length of hospital stay (days)
Measured: Up to Day 29
Length of ICU stay (days)
Measured: Up to Day 29
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups
Measured: Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start24 Sep 2020
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaperon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-Yong Seong, Dr., Study chair, Shaperon Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565379
- Sponsor's protocol ID
- Shaperon001
- Other IDs
- 2020-003107-34
- Status last verified
- Jan 2022
- First submitted
- 23 Sep 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Phase 2 Clinical Trial to Investigate the Efficacy and Safety of 2 Doses of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
- ClinicalTrials.gov ID
- NCT04565379
- Acronym / sponsor ID
- Shaperon001
- Conditions
- COVID19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ShaperonIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NuSepin® 0.1 mg | Active comparator | Drug: NuSepin® 0.1 mgNuSepin® 0.1 mg/kg in 100 ml normal saline infusion |
| NuSepin® 0.2 mg | Active comparator | Drug: NuSepin® 0.2 mgNuSepin® 0.2 mg/kg in 100 ml normal saline infusion |
| Placebo | Placebo comparator | Drug: Placebo100 ml normal saline infusion |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects aged between 18≤ and <80 years old
- Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization
- Diagnosis of pneumonia based on:
- Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109
- Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio < 300mgHg at screening
Key exclusion criteria (7 listed)
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Reduced renal function with estimated glomerular filtration rate (eGFR) < 30 ml/min or hemodialysis or hemofiltration.
- Pregnancy or breast feeding.
- Evidence of multiorgan failure
- Steroid treatment by any reason within 72 hours prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuSepin® 0.1 mgNuSepin® 0.1 mg | Drug | NuSepin® 0.1 mg |
| NuSepin® 0.2 mgNuSepin® 0.2 mg | Drug | NuSepin® 0.2 mg |
| PlaceboNormal Saline | Drug | Placebo |
Primary outcome
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Time frame: Day 29
10 secondary outcomes
Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline
Time frame: Day 15 and Day 29
Clinical Status assessed by the six-category ordinal scale at fixed time points
Time frame: Day 1, 4, 9, 15 and 29
Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours
Time frame: Up to Day 29
All-cause mortality
Time frame: Up to Day 29
Duration (days) of mechanical ventilation
Time frame: Up to Day 29
Duration (days) of extracorporeal membrane oxygenation
Time frame: Up to Day 29
Duration (days) of supplemental oxygenation
Time frame: Up to Day 29
Length of hospital stay (days)
Time frame: Up to Day 29
Length of ICU stay (days)
Time frame: Up to Day 29
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups
Time frame: Day 15 and Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Yong Seong, Dr. study chair
Shaperon Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NuSepin® 0.1 mg and NuSepin® 0.2 mg in people with COVID19 Pneumonia, run by Shaperon at 5 sites in Romania.
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 12 inclusion and 7 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Romania. 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. Some participants in this study may receive a placebo. 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?
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days) (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2022.