COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04602000

ChangWoo Park

ChangWoo.Park@celltrion.com

2020-10-26

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patient had to meet all of the following criteria to be randomized in this study. patient was an adult male or female patient, aged 18 or above. patient was diagnosed with sars-cov-2 infection at screening by using the sponsor-supplied rapid sars-cov-2 diagnostic test or rt-pcr (reverse transcription-polymerase chain reaction). patient with conditions meeting all of the following criteria: oxygen saturation > 94% on room air. not requiring supplemental oxygen. patient who had an onset of symptom no more than 7 days prior to the study drug administration. patient had 1 or more of the sars-cov-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.

patients meeting any of the following criteria were excluded from the study. patient had current severe condition meeting one of the following: previous or current hospitalization or requirement of hospitalization for treatment of serious sars-cov-2 related conditions. respiratory distress with respiratory rate ≥30 breaths/min. required supplemental oxygen experienced shock complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion. patient had received or had a plan to receive any of the following prohibited medications or treatments: drugs with actual or possible antiviral drugs and/or possible anti-sars-cov-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of sars-cov-2 infection prior to study drug administration any sars-cov-2 human iv immunoglobulin, convalescent plasma for the treatment of sars-cov-2 infection prior to study drug administration any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of sars-cov-2 infection prior to the study drug administration use of medications that are contraindicated with soc sars-cov-2 vaccine prior to the study drug administration

5

Celltrion

18

100

Korea;Republic of

Mild disease at enrollment

1: Mild disease at enrollment

1642

Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1);Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2);Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1);Time to Clinical Recovery (Part 1);Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)

None

Phase 2/Phase 3

[{"arm_notes": "40 mg/kg group (Part 1)", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "80 mg/kg group (Part 1)", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "40 mg/kg group (Part 2)", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "(Part 1)", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "(Part 2)", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]