The Italian branch of the RECOVERY (Randomised Evaluation of COVID-19 Therapy) Trial, within which the ID-CARE team at the University Hospital of Verona coordinates the Verona sites, has begun enrolling its first patients.
In early 2020, when the protocol for this study was first being developed, there were no approved treatments for COVID-19, the disease caused by the novel coronavirus SARS-CoV-2 that first appeared in China in late 2019. At that time, the UK New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) recommended evaluating several potential treatments, including Lopinavir-Ritonavir, low-dose corticosteroids, and Hydroxychloroquine, all of which have since been studied. Similarly, the World Health Organization (WHO) issued recommendations to evaluate these treatments and highlighted the need to assess new therapies as they emerged. Since then, advancements in COVID-19 treatment have underscored the importance of obtaining better evidence for treating pneumonia caused by other pathogens, such as influenza and bacteria. Many therapies for these conditions are widely used despite a lack of solid evidence regarding their effectiveness or safety.
This study aims to evaluate whether new treatments can improve outcomes for patients hospitalised with viral or bacterial pneumonia. Key outcomes of interest include mortality, hospital discharge rates, the need for mechanical ventilation. The primary analysis will follow patients for 28 days after randomisation, with additional information on longer-term outcomes collected through the review of medical records or linkage to medical databases where available. The experimental treatments are differentiated based on the type of pneumonia present. Different treatment approaches are applied depending on whether the patient has pneumonia caused by the influenza virus or community-acquired pneumonia resulting from other pathogens. This differentiation aims to provide more targeted and effective care for each patient group.
The inclusion and exclusion criteria are verified by the co-investigators in the ID-CARE team at the University Hospital of Verona by accessing the patient’s electronic file to determine eligibility for enrolment. If the patient is eligible, the co-investigators complete the screening log and proceed with randomisation and subsequent follow-up. After the follow-up assessment is completed, it is documented in the work file, and the electronic case report form (eCRF) is filled out. If the patient dies or is discharged before 28 days from enrolment, the follow-up is updated accordingly.
Find out more about this trial here: https://www.ecraid.eu/study/recovery
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