Protocol summary
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Study aim
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Determining Levamisole efficacy in the treatment of outpatient COVID19 infected individuals
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Design
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Two arm-parallel-group randomized trial in phase 3 on a minimum of 250 patients.
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Settings and conduct
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It will be implemented in covid19 selected and referral- centers of Tehran and its districts. Patients with positive PCR for COVID19 are included in the study. over the first visit, patients are randomly assigned to control or case groups by the physician by the block randomization method. Patients are then followed up by health care providers 6 times. Due to the nature of levamisole, which is a tablet, the placebo can not be used in this study. In this study, blinding will not be possible(only the analyzer is blinded)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
18 years or older
Positive COVID-19 PCR ;
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:
Bacterial or fungal infection;
History of allergic reaction to levamisole;
Use of drugs and antibiotics other than those used in the national COVID-19 treatment protocol;
Shortness of breath due to cardiogenic pulmonary edema;
Pregnancy
Breastfeeding;
Patients with unstable hemodynamics;
History of cirrhosis, hepatitis, or severe liver disease,
GFR less than 30 ml/min
Patients receiving chemotherapy for cancer.
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Intervention groups
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In the control group, patients will receive the routine medicine prescribed based on the national protocol for the management of COVID19. In the intervention group, levamisole will be prescribed as an add-on therapy
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Main outcome variables
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The general condition of the patient;
admission;
mortality;
Dyspnea;
Cough;
Diarrhea;
Nausea;
Vomiting;
Myalgia;
Headache;
Fever;
Anosmia;
Dysgeusia
General information
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Reason for update
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in order to expedite collecting the sample size, we implemented the trial as a multicenter study. Also, due to the lack of necessary infrastructure for blinding, the trial is enabled.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201124049480N1
Registration date:
2021-03-28, 1400/01/08
Registration timing:
prospective
Last update:
2021-09-24, 1400/07/02
Update count:
1
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Registration date
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2021-03-28, 1400/01/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-21, 1400/02/01
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Expected recruitment end date
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2021-09-21, 1400/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of Levamisole efficacy in treatment of COVID-19 and comparing it to the common treatment: a Clinical Trial
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Public title
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Efficacy of Levamisol in Treating COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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:
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
365
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization (Permuted block randomization) will be used as the randomization method in this study. 6 quadruple blocks including AABB, ABAB, ABBA, BBAA, BABA, and BAAB are determined and then for each of the 4 patients, one of these 6 blocks will be used by a random number table. In fact, according to the order specified in each block, two patients will receive treatment A (treatment with levamisole) and two patients will receive treatment B (treatment without levamisole).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-06, 1399/10/17
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Ethics committee reference number
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IR.AJAUMS.REC.1399.199
Health conditions studied
1
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Description of health condition studied
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outpatient covid19 infected individuals
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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the general condition of the patient
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Timepoint
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Days 1,3,5,7,9,14
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Method of measurement
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Verbal Numeric Scale(VNS)
Secondary outcomes
1
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Description
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hospital admission
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
2
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Description
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mortality rate
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
3
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Description
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cough
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
4
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Description
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sore throat
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
5
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Description
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Dyspnea
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
6
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Description
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Myalgia
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
7
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Description
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Diarrhea
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
8
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Description
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vomiting
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
9
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Description
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nausea
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
10
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Description
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Anosmia
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
11
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Description
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dysgeusia
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
12
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Description
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headache
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
13
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Description
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fever
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Timepoint
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Day 1,3,5,7,9,14
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Method of measurement
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telephone
Intervention groups
1
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Description
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Intervention group: Levamisole 50 mg/day for ten days + routine management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.)
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Category
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Treatment - Drugs
2
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Description
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Control group: routine outpatient management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected de-identified participant data sets are to be shared
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When the data will become available and for how long
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the data will be available if requested via E-mail after publishing the article
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To whom data/document is available
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scientists who are willing to have access to our data should show some proof they are working in similar areas, e.g by sending the proposal. after evaluating the files by the authors, the data will be sent at their discretion..
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Under which criteria data/document could be used
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if they are conducting similar researches and they intend to compare the efficacy of levamisol with other drugs.
if they intend to increase the study population of our study and add it to their own work.
if they intend to perform an analysis to check if the results are correct.
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From where data/document is obtainable
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they can send an email to mh_asgardoon@yahoo.com
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What processes are involved for a request to access data/document
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The applicant must first explain the reasons behind their request to use our data via an email and send the documents such as the proposal file, ethics committee or the grant number received from the their institute. After correspondence and confirmation, the data will be sent. The data of this study will be available after October 2021.
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Comments
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