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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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24 June 2021 |
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Main ID: |
KCT0006254 |
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Date of registration:
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2021-06-14 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase ? Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
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Scientific title:
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Phase ? Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection |
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Date of first enrolment:
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2021-02-03 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=19522 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable
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Phase:
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Phase2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jin Yong
Kim |
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Address:
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217 Banchuk-ro, Dong-gu, Incheon
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Telephone:
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+82-32-580-6496 |
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Email:
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kjykey@gmail.com |
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Affiliation:
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Incheon Medical Center |
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Name:
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Jin Yong
Kim |
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Address:
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217 Banchuk-ro, Dong-gu, Incheon
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Telephone:
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+82-32-580-6496 |
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Email:
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kjykey@gmail.com |
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Affiliation:
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Incheon Medical Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: • mild COVID-19 infection diagnosed by RT-PCR.
• no more than 7 days prior to the study drug administration from the onset of symptoms
Exclusion criteria: •Someone who needs supplemental oxygen therapy for SARS-CoV-2 infection.
•According to World Health Organization guidelines, 2020 Any conditions suspected of being severe symptoms of SARS-CoV-2 infection.
Age minimum:
18?(Year)
Age maximum:
No Limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Certain infectious and parasitic diseases
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Intervention(s)
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Drug : 40 mg/kg of Regdanvimab (960 mg/16 mL) administered by intravenous (IV) for 90 minutes (with a margin of error of ±15 minutes).
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Primary Outcome(s)
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Treatment-emergent adverse events
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Secondary Outcome(s)
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Clinical laboratory test(clinical chemistry, hematology, and urinalysis)
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Potential effects on the incidence of antibody-dependent enhancement
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Source(s) of Monetary Support
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Celltrion
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Ethics review
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Status: Submitted approval
Approval date: 12/01/2021
Contact:
+82-32-580-6565
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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