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Background. Bronchoalveolar lavage (BAL) is currently not recommended in noncritically ill patients for the diagnosis of SARS-CoV-2 infection. Indeed, the diagnosis is based on the RT-PCR test on a nasopharyngeal swab (NPS) and abnormal findings on the chest CT scan. However, the sensitivity of the NPS and the specificity of the chest CT scan are low. Results of BAL in case of negative NPS testing are underreported, especially in the subgroup of immunocompromised patients. Objectives. The added value of BAL in the management of unstable, but noncritically ill patients, suspected of having SARS-CoV-2 infection despite one previous negative NPS and the side effects of the procedure for the patients and the health-care providers, were assessed during the epidemic peak of the COVID-19 outbreak in Belgium. Methods. This multicentric study included all consecutive noncritically ill patients hospitalized with a clinical and radiological suspicion of SARS-CoV-2 infection but with a negative NPS. BAL was performed according to a predefined decisional algorithm based on their state of immunocompetence, the chest CT scan features, and their respiratory status. Results. Among the 55 patients included in the study, 14 patients were diagnosed with a SARS-CoV-2 infection. Interestingly, there was a relationship between the cycle threshold of the RT-PCR and the interval of time between the symptom onset and the BAL procedure ( Pearso n ’ s   correlation   coefficient = 0.8 , p = 0.0004 ). Therapeutic management was changed in 33 patients because another infectious agent was identified in 23 patients or because an alternative diagnosis was made in 10 patients. In immunocompromised patients, the impact of BAL was even more marked (change in therapy for 13/17 patients). No significant adverse event was noted for patients or health-care staff. All health-care workers remained negative for SARS-CoV-2 NPS and serology at the end of the study. Conclusions. In this real-life study, BAL can be performed safely in selected noncritically ill patients suspected of SARS-CoV-2 infection, providing significant clinical benefits that outweigh the risks.

Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

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