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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006254

Enrollment

Registered

2021-06-14

Start date

2021-02-03

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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).

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events	—

Secondary

Measure	Time frame
Potential effects on the incidence of antibody-dependent enhancement;Clinical laboratory test(clinical chemistry, hematology, and urinalysis)	—

Countries

Korea, Republic of

Contacts

Public ContactJin Yong Kim

Incheon Medical Center

kjykey@gmail.com+82-32-580-6496

Outcome results