Trial IRCT20190810044500N7
Publication Roostaei A, BMC Infect Dis, 2021 (published paper)
Dates: 2020-04-12 to 2020-08-02
Funding: Public/non profit (Research and Technology Department of Shahid Sadoughi University of Medical Science)
Conflict of interest: No

Methods
RCT
Blinding: quadruple blinding
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteriaAge 18 to 60 years;
Diagnosis of COVID-19 in the previous 24 h based on the clinical signs and symptoms and radiographical manifestations in lung CT scan;
Female patients should not be exposed to pregnancy and should not become pregnant until 30 days after the end of the study;
Do not take levamisole during the last five days (due to the half-life of the drug 16 hours);
Room-air oxygen saturation > 94%
Exclusion criteriaPatients hospitalized;
Patients with hemodynamic instability;
History of cirrhosis, hepatitis and severe liver disease, severe renal failure (creatinine clearance less than 30 ml /min);
Patients taking levamisole for other uses such as parasitic infections;
Patients with a history of allergic reaction or allergy to levamisole;
Patients receiving chemotherapy for cancer
Pregnancy and lactation.
Interventions
Treatment
Levamisole
50 mg orally three times daily for 3 days
Control
Placebo ( / )
Duration :
Participants
Randomized
52 participants (n1=27 / n2= 25)
Characteristics of participants
N=52
Mean age : NR
30 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Clinical symptoms include fever, cough, shortness of breath
In the report
NR
Documents
avalaible

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
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 pre-print article the trial registy was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. There were no substantive differences between the trial registry and pre-print article in population, procedures, interventions or outcomes.
This study was updated on April 06th, 2021, with data from the published report.