Trial NCT04348409
Publication Blum VF, EClinicalMedicine (2021) (published paper)
Dates: 2020-05-20 to 2020-09-21
Funding: Private (Farmoquimica (FQM), Brazil)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Brazil
Follow-up duration (days): 21
Inclusion criteria
  • Diagnosed with COVID-19
  • positive qPCR and compatible symptoms
  • aged 18 years or older, both genders
  • hospitalized in a non-critical condition with mild respiratory insufficiency
  • maximum of 36 hours of symptoms.
Exclusion criteria
  • Patients infected with HIV, HTLV I or II
  • participants in antineoplastic treatment
  • patients with severe autoimmune diseases in immunosuppression
  • transplant recipients, pregnant or lactating women, or any other clinical condition that the Investigator deemed to be an imminent risk to health and participant's life were excluded. Patients who received previous therapies for COVID-19 of any kind were excluded, as well as medications that would be directed against specific manifestations of COVID-19, such as monoclonal antibodies or anti interleukins.
Interventions
Treatment
Nitazoxanide
600 mg orally twice a day for 7 days
Control
Placebo

Participants
Randomized
participants :
Nitazoxanide =25
Placebo=25
Characteristics of participants
N= 50
Mean age : NR
15 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Viral load [ Time Frame: day 1, 4, 7, 14 and 21 ]
In the report
Virological response to treatment
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
Some concerns
General comment In addition to the peer-reviewed journal publication and pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. The study achieved its pre-stated sample size. There is no significant difference from the trial registration in the population or intervention and control treatments. The scale used to categorize clinical status differed between the trial registry and the pre-print article, having been adapted to include fewer points for assessment of a small sample. The article reports adverse events and several laboratory outcomes that were not included in the registry. Only proportions were reported for clinical improvement (hospital discharge) with unclear denominators and number of cases. Viral negative conversion was reported, but at a follow-up duration that was too long for the COIVD-19 NMA (21 days); thus it was not included. On 26th of July, 2021, this study was updated based on updated pre-print.
On December 23rd, 2021, this study was updated after publication of a corrigendum.