COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003107-34/RO

Shaperon Inc - Clinical Trial Desk

ctdesk@shaperon.com

2022-05-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female subjects ≥18 years and < 80 years. 2. Laboratory-confirmed SARS-CoV-2 infection by PCR for the first time within 72 hours prior to randomization 3. 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 4. Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109 /L 5. Patients with SpO2≤94% on room air or Pa02/FI02 ratio <300mgHg at screening 6. Patients capable to give consent and who have signed the informed consent form before any trial related assessment. 7. 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.

1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal. 2. Reduced renal function with estimated glomerular filtration rate (eGFR) < 30 ml/min or hemodialysis or hemofiltration. 3. Pregnancy or breast feeding. 4. Evidence of multiorgan failure 5. Steroid treatment by any reason within 72 hours prior to enrolment 6. Participation in any other clinical trial of an experimental agent treatment for COVID-19 7. 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.

3

Shaperon Inc

18

80

Korea;Republic of

Severe disease at enrollment

6: Severe disease at enrollment

60

Difference in Time to Clinical Improvement (TTCI) [Censored at Day 29] [Time Frame: up to 29 days] between the 2 treatment and the placebo group. The primary endpoint parameter is time to clinical improvement (censored at Day 29), defined as the time (in days) from randomization of study treatment (NuSepin or placebo) until a decline of two categories on a six-category ordinal scale* of clinical status (1 ꞊ complete clinical remission, 6 ꞊ death) * Six-category ordinal scale: 6. Death, 5. ICU, requiring ECMO and/or IMV, 4. ICU/hospitalization, requiring NIV/ HFNC therapy, 3. Hospitalization, requiring supplemental oxygen (such as LFNC or facial mask), 2. Hospitalization, not requiring supplemental oxygen, 1. Complete clinical remission, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Abbreviations: IMV= invasive mechanical ventilation, NIV= non-invasive mechanical ventilation, HFNC= High-flow nasal cannula, LFNC= Low-flow nasal cannula.

Declared number of arm (4.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": null, "treatment_id": 914, "treatment_name": "Nusepin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]