Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea.

Introduction: Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of coronavirus disease 2019 (COVID-19) in South Korea in 2021. The Ministry of Food and Drug Safety in South Korea mandate that new medications be re-examined for safety and effectiveness post-approval in at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate the safety and effectiveness of regdanvimab in real-world clinical care.

Variation between hospitals and reviewers in detection of adverse events identified through medical record review in Korea.

Objectives: This study utilized the method of medical record review to determine characteristics of adverse events that occurred in the inpatient units of hospitals in Korea as well as the variations in adverse events between institutions.

Design: A two-stage retrospective medical record review was conducted. The first stage was a nurse review, where two nurses reviewed medical records of discharged patients to determine if screening criteria had been met.

Clinical and Laboratory Findings of Middle East Respiratory Syndrome Coronavirus Infection.

There is a paucity of data regarding the differentiating characteristics of patients with laboratory-confirmed and those negative for Middle East respiratory syndrome coronavirus (MERS-CoV) in South Korea. This hospital-based retrospective study compared MERS-CoV-positive and MERS-CoV-negative patients. A total of seven positive patients and 55 negative patients with a median age of 43 years (P = 0.