Study identification

EU PAS number

EUPAS34966

Study ID

34967

Official title and acronym

Effects of baricitinib on respiratory function in patients treated with corticosteroids for SARS-CoV-2 pneumonia: an observational cohort study (BARI-COVID19)

DARWIN EU® study

No

Study countries

Spain

Study description

Objectives. The Janus kinase (JAK) inhibitor baricitinib may block viral entry into pneumocytes and prevent cytokine storm in patients with SARS-CoV-2 pneumonia. We aimed to assess whether baricitinib improved pulmonary function in patients treated with high-dose corticosteroids for moderate to severe SARS-CoV-2 pneumonia.Methods. This observational study will enroll patients with moderate to severe SARS-CoV-2 pneumonia (PaO2/FiO2 less than 200 mmHg) who received either lopinavir/ritonavir and hydroxychloroquine plus corticosteroids (CS group, n=50) or plus corticosteroids and baricitinib (BCT-CS group, n=62). The primary endpoint is the change in SpO2/FiO2 (oxygen saturation as measured by pulse oximetry, SpO2/fraction of inspired oxygen, FiO2) from hospitalization to discharge. Secondary endpoints include the proportion of patients requiring supplemental oxygen at discharge and one month later. Statistics will be adjusted by the inverse propensity score weighting (IPSW).

Study status

Finalised

Contact details

Jose Luis Rodríguez García

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Lilly
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable