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Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial.
Gyselinck, Iwein; Liesenborghs, Laurens; Landeloos, Ewout; Belmans, Ann; Verbeke, Geert; Verhamme, Peter; Vos, Robin; Janssens, W.
  • Gyselinck I; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium. iwein.gyselinck@kuleuven.be.
  • Liesenborghs L; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
  • Landeloos E; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
  • Belmans A; Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Leuven, Belgium.
  • Verbeke G; Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Leuven, Belgium.
  • Verhamme P; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
  • Vos R; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
  • Janssens W; Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Trials ; 22(1): 126, 2021 Feb 09.
Article in English | MEDLINE | ID: covidwho-1076154
Semantic information from SemMedBD (by NLM)
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2. azithromycin TREATS COVID-19
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3. COVID-19 PROCESS_OF hospitalized patients
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4. azithromycin TREATS hospitalized patients
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5. Intervention regimes TREATS COVID-19
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6. COVID-19 PROCESS_OF Patients
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COVID-19
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7. azithromycin TREATS Patients
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8. COVID-19 ASSOCIATED_WITH Cytokine Signaling
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ABSTRACT

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 21 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Azithromycin / Standard of Care / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05033-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Azithromycin / Standard of Care / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05033-x