Updates are available Correction dated 2023-05-22

Article History

Received: 28 February 2022

Accepted: 8 July 2022

First Online: 22 July 2022

Change Date: 22 May 2023

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1186/s13063-023-07364-3

Declarations

:

: Before initiation of the trial at any clinical site, the protocol, all informed consent forms, and any material to be given to the prospective participant will be submitted to the relevant EC for approval. Any subsequent amendments to these documents will be submitted for further approval. Before initiation of the trial at each additional clinical site, the same/amended documents will be submitted for local permissions.The rights of the participant to refuse to participate in the trial without giving a reason must be respected. After the participant has entered the trial, the clinician remains free to give alternative treatment to that specified in the protocol, at any stage, if they assess this to be in the best interest of the participant. The reasons for doing so must be recorded. After randomisation the participant must remain within the trial for follow-up and data analysis according to the treatment option to which they have been allocated. However, the participant remains free to change their mind at any time about the protocol treatment and follow-up without giving a reason and without prejudicing their further treatment.Competent Authority Approvals.National Committee of Scientific Investigation (IRB00003566) on Feb 10th, 2020; and by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).Other Approvals.The protocol will be submitted by those delegated to do so to the Health Research Authority for national approval and relevant R&D departments of each participating site for review of local Trust Capacity and Capability. A copy of the local permissions (or other relevant approval as above) and of the consent form on local headed paper must be forwarded to the coordinating centre before participants are randomised to the trial.

: Integral Consent Form, version 4, dated November 12th, 2021, on page 13 states that:“When the trial is completed, the researchers will share the trial data on an openly accessible website at the end of the trial to help other researchers studying COVID-19. You will not be identifiable on this website. The researchers may also share the trial data with commercial organisations such as drug companies, this data will not include your personal data will have a code number. We will also publish the results in a medical journal, so that other doctors can see them. Your identity and any personal details will be kept confidential. No named information about you will be published in any report of this trial.”The informed consent materials are in Spanish and are available from the corresponding author on request.

: The primary objective of this trial has been funded by Siegfried Rhein, S.A. de C.V. Other sources of financing may be included for the completion of the secondary outcomes.T.A.S. has received personal fees from Siegfried Rhein, S.A. de C.V.University College London. J.F.S. was supported by United Kingdom Medical Research Council (MRC) Fellowships (Grants M008665 and P014534)Nitazoxanide and nitazoxanide placebo were donated by Siegfried Rhein, S.A. de C.V.Favipiravir was donated by Strides Pharma Limited.