Determining Levamisole efficacy in the treatment of outpatient COVID19 infected individuals
Design
Two arm-parallel-group randomized trial in phase 3 on a minimum of 250 patients.
Settings and conduct
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)
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
The general condition of the patient;
admission;
mortality;
Dyspnea;
Cough;
Diarrhea;
Nausea;
Vomiting;
Myalgia;
Headache;
Fever;
Anosmia;
Dysgeusia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201124049480N1
Registration date:2021-03-28, 1400/01/08
Registration timing:prospective
Last update:2021-03-28, 1400/01/08
Update count:1
Registration date
2021-03-28, 1400/01/08
Registrant information
Name
Mohammad Hossein Asgardoon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3334
Email address
mh_asgardoon@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Levamisole efficacy in treatment of COVID-19 and comparing it to the common treatment: a Clinical Trial
Public title
Efficacy of Levamisol in Treating COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
Tehran - West Fatemi St. - Shahid Etemadzadeh St. AJA University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.AJAUMS.REC.1399.199
Health conditions studied
1
Description of health condition studied
outpatient covid19 infected individuals
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
the general condition of the patient
Timepoint
Days 1,2,3,4,14,28
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
hospital admission
Timepoint
day 1,2,3,4,14,28
Method of measurement
telephone
2
Description
mortality rate
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
3
Description
cough
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
4
Description
sore throat
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
5
Description
Dyspnea
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
6
Description
Myalgia
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
7
Description
Diarrhea
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
8
Description
vomiting
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
9
Description
nausea
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
10
Description
Anosmia
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
11
Description
dysgeusia
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
12
Description
headache
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
13
Description
fever
Timepoint
Day 1,2,3,4,14,28
Method of measurement
telephone
Intervention groups
1
Description
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.)
Category
Treatment - Drugs
2
Description
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.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
COVID19
Full name of responsible person
Mohammad Hossein Asgardoon
Street address
Childrens Med Center Hosp, 62 Qarib St., Keshavarz Blvd, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6119 0000
Email
mh_asgardoon@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Yusefi
Street address
Tehran - West Fatemi St. - End of Etemadzadeh St. - Aja University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
mh_asgardoon@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Aminianfar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
West Fatemi St. - End of Etemadzadeh St. - Aja University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
maminianfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Emadi Kouchak
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
00982161190
Email
emadiham@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hossein Asgardoon
Position
MD,MPH
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
North Arash st. Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1438643674
Phone
+98 911 910 3051
Email
mh_asgardoon@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected de-identified participant data sets are to be shared
When the data will become available and for how long
the data will be available if requested via E-mail after publishing the article
To whom data/document is available
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..
Under which criteria data/document could be used
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.
From where data/document is obtainable
they can send an email to mh_asgardoon@yahoo.com
What processes are involved for a request to access data/document
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.