Covid-19 living Data

Levamisole vs Standard care/Placebo (RCT)

Mild outpatients

FOREST PLOTS -2022-04-29

Studies description

Trial IRCT20201124049480N1
Publication Asgardoon M, ResearchSquare (2021) (preprint)
Dates: 2021-04-15 to 2021-09-15
Funding: Public/non profit (AJA University of Medical Sciences)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Iran Follow-up duration (days): 14
Inclusion criteria	non-hospitalized either signs and symptoms indicating COVID-19 or spiral chest CT-scan indicating COVID19 or PCR-confirmed COVID-19 infection aged 18 years or older informed consent acceptance of the patient or his companion for taking the drug had not taken LVM during the previous five days (due to the 16-hour half-life of the drug).
Exclusion criteria	Negative RT-PCR for COVID-19 history of hepatitis, cirrhosis, or severe liver disorders severe renal failure (estimated glomerular filtration rate less than 30 mL/min) shortness of breath due to cardiogenic pulmonary edema taking LVM for any other reason (e.g., parasitic infections) history of allergic reaction or known allergy to LVM or any hypersensitivity reaction to LVM history of cancer chemotherapy lactating or pregnant women or planning to get pregnant within 30 days of the trial.
Interventions
	Treatment Levamisole 50 mg/day orally for ten days
	Control Standard care
Participants
	Randomized participants : Levamisole=253 Standard care=254
	Characteristics of participants N= 507 Mean age : NR 201 males Severity : Mild: n= 507/ Asymptomatic: n=0
Primary outcome
	In the register the general condition of the patient Timepoint Days 1,2,3,4,14,28 Method of measurement Visual Analogue Scale(VAS)
	In the report self-reported general health condition of the participants measured by VNS on days 3,5,7,9,14.
Documents avalaible	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 published article, the prospective study registry was used in data extraction and risk of bias assessment. No protocol or statistical analysis plan were available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome method of measurement (VAS) does not reflect the reported primary outcome measurement method (VNS). Secondary outcomes in the paper had different time points that those specified in the registry. The study (n=507) achieved the target sample size (n=250) specified in the trial registry."

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:
	Location : Single center / Iran Follow-up duration (days): 14
Inclusion criteria	Age 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 criteria	Patients 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
Participants
	Randomized participants : Levamisole=27 Placebo=25
	Characteristics of participants N= 52 Mean age : NR 30 males Severity : Mild: n= 50/ Asymptomatic: 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 willing stated in the publication: Not reported
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.