Study identification

EU PAS number

EUPAS106412

Study ID

106413

Official title and acronym

An Observational Study to Assess the Real-world Effectiveness and Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System (VALOR DOD)

DARWIN EU® study

No

Study countries

United States

Study description

The novel coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite relatively high vaccine uptake (approximately 85% of the US population aged 5 years and older has received at least one COVID-19 vaccination dose), and aggressive introduction of vaccination booster programs to maintain/increase protection levels, there were approximately 260,000 COVID-19 cases and 2,500 deaths recorded in the US weekly as of 25 October 2022. Persons who are immunocompromised are particularly vulnerable to become infected with SARS-CoV-2 and to also experience severe illness. Paradoxically, these individuals also are more likely to experience suboptimal vaccine response, thereby placing them at greater risk of infection. EVUSHELD™ is a combination product of tixagevimab and cilgavimab, both of which are neutralizing IgG1 monoclonal antibodies that bind to distinct, non-overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV-2. On 26 January 2023, the US FDA stated that EVUSHELD (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use in pre-exposure prophylaxis of COVID-19 in the US until further notice due to the high frequency of circulating SARS-CoV-2 variants that EVUSHELD does not neutralize. Accordingly, this Phase IV observational, retrospective study, based on analyses of secondary electronic healthcare databases will assess real-world effectiveness of EVUSHELD as PrEP among EVUSHELD-eligible persons against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19-related outcomes. The primary effectiveness outcomes is COVID-19 hospitalization up to 6 months after exposure. The primary safety outcomes will be anaphylaxis, MIS, HF, MI, stroke, and DVT.

Study status

Ongoing

Contact details

Jess Edison

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable