Covid-19 Living Data

Trial NCT05033145
Publication Cabral P, ResearchSquare (2022) (preprint)
Dates: 2022-01-15 to 2022-05-30
Funding: Not reported/unclear (The authors thank HRH Pharmaceuticals Limited, Instituto Galzu, as well as all the professionals who, with their efforts made this research possible.)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Brazil Follow-up duration (days): 60
Inclusion criteria	Age 18 and over regardless of gender respiratory or blood samples that were tested positive for SARS-CoV-2 nucleic acid by RT-PCR, or respiratory or blood samples that were tested highly homologous with the known SARS-CoV-2 by viral gene sequencing the confirmation of COVID-19 according to the diagnostic criteria of “the latest Clinical guidelines for novel coronavirus” issued by the World Health Organization (WHO) on 2020 January 28 Symptomatic patients who meet the WHO case definition for COVID-19 without evidence of viral pneumonia or hypoxia (Sat O2 < 95%)13P. [score 1-3]
Exclusion criteria	Known or suspected allergy to the composition of AZVUDINE tablets patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption, the need for intravenous nutrition or an inability to take oral medication patients on anti-HIV treatment patients with one of the following conditions: respiratory failure and the need for mechanical ventilation shock intensive care unit (ICU) monitoring and treatment for other organ failures pregnant women or those who were lactating or may have a birth plan during the trial period and within 6 months after the end of the trial patients participating in other clinical trials or using experimental drugs within 12 weeks before administration patients with other conditions that were not suitable for participating in this experiment according to the judgment of the researcher Patients being treated with other antivirals (e.g., lopinavir/ritonavir, remdesivir, umifenovir/arbidol, favipiravir, interferon-α) or immunosuppressive medications for other medical conditions Patients under treatment with monoclonal antibodies (Ex: tocilizumab and sarilumab/kevzara)
Interventions
	Treatment Azvudine 5 mg (five 1 mg tablets) orally once a day for up to 14 days
	Control Placebo
Participants
	Randomized participants : Placebo=156 Azvudine=156
	Characteristics of participants N= 312 Mean age : NR 111 males Severity : Mild: n= 281/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1) Proportion of patients hospitalized during the study through day 28 [Time Frame: Day 14 to Day 30]: WHO clinical progression ordinal scale (Jun/2020), Score 4 to 10. Health Organization Ordinal Clinical Progression Scale (WHO, Jun/2020; scale 0 [asymptomatic] to 10 [death]), with score 4 to 7. 2) Proportion of participants with a clinical outcome of CURE during the study; [Time Frame: Day 14 to Day 30]: The clinical outcome of cure is defined in this protocol as the absence of viral RNA in samples collected and clinical conditions for outpatient discharge.
	In the report Proportion of patients hospitalized during the study through day 28, according to the WHO Ordinary Clinical Progression Scale (Jun/2020), Score 4 to 10.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the preprint and its supplement, the protocol and study registry were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry and protocol. There is no change from the trial registration in the intervention and control treatments. The registry has an additional primary outcome that is not reflected in the reported primary outcomes.