Trial NCT04753619
Publication Abdulamir A, Ann Med Surg (2021) (published paper)
Dates: 2021-01-01 to 2021-04-30
Funding: No specific funding (None)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Iraq
Follow-up duration (days): 30
Inclusion criteria
  • Patients with age above 18 years and of any gender
  • Definite diagnosis of COVID-19 according to the WHO classification criteria
  • Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases
  • Understands and agrees to comply with planned study procedures.
Exclusion criteria
  • Patients refuse to enrol in the study
  • Patients with hypersensitivity or severe adverse effects to niclosamide
  • Renal impairment (serum creatinine> 2 mg/dl)
  • Hepatic impairment(Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal
  • Pregnancy or a desire to become pregnant
  • Breast feeding.
Interventions
Treatment
Niclosamide
Initial dose: 2 g chewable, then 1 g every 12 hours on day 1; Maintenance dose: 1 g 3 times a day for 7 days via nasogastric or orogastric tube.
Control
Standard care

Participants
Randomized
participants :
Niclosamide=75
Standard care=75
Characteristics of participants
N= 150
Mean age : NR
80 males
Severity : Mild: n=* / Moderate: n=50 / Severe: n=50 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Percentage of Cure of the patient [ Time Frame: 7 days ] To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging. Time to recovery [ Time Frame: 7 days ] - to study the time to recovery ( stay days in hospital)
In the report
Percentage of recovered patients and evaluated by physician’s judgment on clinical recovery from the time of assessment over 30 days
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

N
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 published journal and pre-print articles, the retrospective registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The authors report that the trial was registered nationally, but this was not available. Mortality was the only outcome eligible for COVID NMA reported.
This trial was updated on October 6th, 2021 with data from the peer-reviewed publication.