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
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.|
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.
Standard care ( / )
Definition of Standard care: Standard of care which included all or some of the following, according to the clinical condition of each patient: Acetaminophen 500mg on need. Vitamin C 1000mg twice/ day. Zinc 75-125 mg/day. 12 mg ivermectin single dose and 200 mg doxycycline on day 1, followed by 100 mg every 12 h for the next 4 days. Favipravir course of therapy (1600mg twice daily in the first day then 600mg twice daily for up to 10 days total). Vitamin D3 5000IU/day. Azithromycin 250mg/day for 5 days. Oxygen therapy/ CBAP if needed. Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed. Mechanical ventilation, if needed.
150 participants (n1=75 / n2= 75)
|Characteristics of participants|
Mean age : 49.3
Severity : Mild: n=* / Moderate: n=50/ Severe: n=50 Critical: n=0
|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
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
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.