General Drug Use Surveillance of RONAPREVE injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -

General Drug Use Surveillance of RONAPREVE injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset - - General Drug Use Surveillance of RONAPREVE injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044927

Enrollment

770

Registered

2021-08-31

Start date

2021-11-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

SARS-CoV-2 infection. Prevention of SARS-CoV-2 infection.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cases eligible for enrollment: Cases with SARS-CoV-2 infection or at risk who are expected to receive RONAPREVE for the first time during the enrollment period at surveillance-contracted institutions. Cases eligible for case report form (CRF) collection: All cases eligible for enrollment who receive RONAPREVE.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Primary surveillance items, etc. 1)Institution information Name of institution, name of department, name of physician 2)Patient demographics Patient initials, sex, (Yes/No) pregnancy, (Yes/No) breastfeeding, ID number, age at treatment initiation, medical treatment classification, reason for use, risk factors for severe disease, previous disease, concurrent disease, smoking history, allergy history, COVID-19 vaccine history, mutant strain test. Only for SARS-CoV-2 infection: Seriousness before treatment, clinical manifestations at treatment initiation, respiratory care at treatment initiation, oxygen saturation (SpO2) at treatment initiation, date of onset (first symptoms noticed) 3)Only for SARS-CoV-2 infection: (Yes/No) previous treatments and if yes: name of previous treatment 4)RONAPREVE treatment status Route of administration, dose per administration, administration site (only for subcutaneous injection), administration time (only for intravenous injection), administration date 5)Only for SARS-CoV-2 infection: Outcome of SARS-CoV-2 infection, outcome 6)Only for prevention of SARS-CoV-2 infection: (Yes/No) onset of SARS-CoV-2 infection, date of last observation or onset 7)Concomitant treatments (Yes/No) and if yes: name of treatment, treatment start date, treatment stop date 8)Adverse events (Yes/No) and if yes: adverse event name, date of onset, seriousness, worst grade, action taken (for RONAPREVE, other), outcome, date of outcome, causal relationship (with RONAPREVE, other factors)	—

Measure

Time frame

Primary surveillance items, etc. 1)Institution information Name of institution, name of department, name of physician 2)Patient demographics Patient initials, sex, (Yes/No) pregnancy, (Yes/No) breastfeeding, ID number, age at treatment initiation, medical treatment classification, reason for use, risk factors for severe disease, previous disease, concurrent disease, smoking history, allergy history, COVID-19 vaccine history, mutant strain test. Only for SARS-CoV-2 infection: Seriousness before treatment, clinical manifestations at treatment initiation, respiratory care at treatment initiation, oxygen saturation (SpO2) at treatment initiation, date of onset (first symptoms noticed) 3)Only for SARS-CoV-2 infection: (Yes/No) previous treatments and if yes: name of previous treatment 4)RONAPREVE treatment status Route of administration, dose per administration, administration site (only for subcutaneous injection), administration time (only for intravenous injection), administration date 5)Only for SARS-CoV-2 infection: Outcome of SARS-CoV-2 infection, outcome 6)Only for prevention of SARS-CoV-2 infection: (Yes/No) onset of SARS-CoV-2 infection, date of last observation or onset 7)Concomitant treatments (Yes/No) and if yes: name of treatment, treatment start date, treatment stop date 8)Adverse events (Yes/No) and if yes: adverse event name, date of onset, seriousness, worst grade, action taken (for RONAPREVE, other), outcome, date of outcome, causal relationship (with RONAPREVE, other factors)

—

Countries

Japan

Contacts

Public ContactRyousue Harada

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

haradarus@chugai-pharm.co.jp03-3281-6611

Outcome results