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Trial - IRCT20201124049480N1


Column Value
Trial registration number IRCT20201124049480N1
Full text link
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Yusefi

Contact
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

mh_asgardoon@yahoo.com

Registration date
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-03-28

Recruitment status
Last imported at : June 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Sept. 24, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Age 18 years or older Positive RT PCR test for COVID-19 Full consent and acceptance of the patient or his companion for taking the drug Patient traceability Women should not become pregnant for 30 days after the end of the study patients should not take levamisole for five days before entering the study (because the half-life of ‎the drug is 16 hours)

Exclusion criteria
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Another justifying cause (such as a bacterial or fungal infection) for the patient's symptoms Allergic reaction to levamisole Use of antibiotics other than those used to treat COVID-19 Shortness of breath due to cardiogenic pulmonary edema Lactation pregnancy Patients with unstable hemodynamics; History of cirrhosis, hepatitis, or severe liver disease, GFR ‎less than 30 ml/min Patients receiving chemotherapy for cancer

Number of arms
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Artesh University of Medical Sciences

Inclusion age min
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

No restriction on type of patients

Severity scale
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0: No restriction on type of patients

Total sample size
Last imported at : Sept. 24, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

365

primary outcome
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

the general condition of the patient

Notes
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : March 29, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 729, "treatment_name": "Levamisole", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]