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Article History

Received: 3 June 2021

Accepted: 9 June 2021

First Online: 3 September 2021

Declarations

:

: The study was approved on 06/11/2020 by the Ethics Committee of the National Institute for Infectious Diseases “Lazzaro Spallanzani” in Rome, designed as National Committee for evaluation of clinical trials on human drugs in COVID-19 patients. Version 3, including non-substantial amendment to the original protocol, was approved on 23/03/2021 by the same committee.Prior to inclusion, potential patients will first receive written and verbal information about the nature, purpose, procedures required by the protocol, possible risks and benefits of the study. Patients will have the time to carefully review the consent form and ask questions prior to completing. Informed consent to participate in the study will be obtained from all participants before enrolment. The original signed informed consent form will be retained in the patient’s records and a copy of the informed consent form will be provided to the patient.We herein certify that this trial has received ethical approval from the appropriate ethical committee as described above.

: Not applicable

: The authors declare that they have no competing interests.