Trial NCT04463264
Publication Silva M, medRxiv (2021) (preprint)
Dates: 2020-07-01 to 2020-12-30
Funding: Private (Laboratorios Roemmers S.A.I.C.F.)
Conflict of interest: Yes

Methods
RCT
Blinding: Single blinded, no restrictions
Location : Multicenter / Argentina
Follow-up duration (days): 35
Inclusion criteria
  • People of both sexes aged ≥ 18 years with COVID-19
  • a positive quantitative real-time polymerase reaction (rtq-PCR)
  • no more than 4 days after the onset of symptoms.
Exclusion criteria
  • Pregnant or lactating women
  • subjects with any contraindication to the use of NTX (according to its package leaflet).
Interventions
Treatment
Nitazoxanide
500 mg orally 4 times a day for 14 days.
Control
Placebo

Participants
Randomized
participants :
Nitazoxanide =33
Placebo=13
Characteristics of participants
N= 46
Mean age : NR
26 males
Severity : Mild: n=25 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th. [Time Frame: 7 day]
In the report
Viral eradication from the patients’ respiratory tract secretions on day 7 after starting treatment (a viral eradication of at least 35% would be clinically relevant).
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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
High
General comment
In addition to the available version of the pre-print article, the study registry was used in data extraction and risk of bias assessment.
There is no change from the trial registration in the intervention and control treatments.
The authors stated that the original protocol included an interim analysis to find any trends upon enrolment of 1/3 of the proposed number of patients (interim analysis). As a result, the target sample size specified in the registry was not achieved and some efficacy outcomes were not reported in the paper.
In this interim analysis only virological outcomes are reported. Other outcomes in the trial registry such as clinical improvement (WHO scale), hospitalization and mechanical ventilation/ICU requirement are not reported.
The primary and secondary efficacy analyses were performed as per protocol. It includes patients with complete data on days 1 and 7 and who received the indicated treatment (two patients without data on day 7 and one patient randomized to NTX but treated with doses well below the protocol doses were excluded).