COVID-19 trials registries data warehouse

https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=21754

YeonSook Kim

not reported

2020-11-27

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

• Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR. • Oxygen saturation >94% on room air, and not requiring supplemental oxygen. • Patient whose onset of symptom is 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.

• Patient had current severe condition meeting one of the following: a. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization Guidance, 2020). b. Respiratory distress with respiratory rate =30 breaths/min. c. Required supplemental oxygen. d. Experienced shock. e. 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 following prohibited medications or treatments: a. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (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. b. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration. c. 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. d. Use of medications that are contraindicated with SoC. e. SARS-CoV-2 vaccine prior to the study drug administration

5

Celltrion

18

100

Democratic People's Republic of Korea

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1600

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 negative conversion in nasopharyngeal swab specimen based on RT-qPCR at each visit (Part 1);Time to negative conversion in nasopharyngeal swab specimen (Part 1);Time to clinical recovery (Part 1);Proportion of patients with clinical symptom requiring hospitalization; oxygen therapy; or experiencing mortality due to SARS-CoV-2 Infection in high-risk patients (Part 2)

Phase 2/Phase 3

[{"arm_notes": "40 mg/kg IV infusion over 90 minutes (\u00b1 15 minutes).", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "80 mg/kg IV infusion over 90 minutes (\u00b1 15 minutes).", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "IV infusion over 90 minutes (\u00b1 15 minutes).", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "40 mg/kg IV infusion over 60 minutes (\u00b1 15 minutes).", "treatment_id": 360, "treatment_name": "Ct-p59", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "IV infusion over 60 minutes (\u00b1 15 minutes).", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]