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Assessment of effect of levamisole on pneumonia caused by COVID-19

Protocol summary

Study aim
Strengthen the non-specific (natural) immune system with levamisole, which leads to a reduction in mortality and complications from COVID 19.
Design
Randomized Double-Blind Controled Trial
Settings and conduct
Both groups are HRCT scanned at the start of the CT scan study. The CT scan is repeated a week later in both groups. Also, at the time of the start of the study, blood counts were performed on all patients and a week later, they were repeated. RT PCR is repeated in the first five weeks and if positive, it is repeated every three days to be negative. Patients in both groups also receive symptomatic therapies prescribed by the therapist.
Participants/Inclusion and exclusion criteria
Patients 18 years of age and older are studied after gaining informed consent. Previous respiratory illnesses: cancer, pregnancy, lactation, immunosuppressive drugs, organ transplants, autoimmune diseases, white blood cells less than 5,000 at baseline can be ruled out.
Intervention groups
The study was designed to be blind and randomized to investigate the effect of levamisole in patients with covid 19. In this study, 50 symptomatic patients (decreased olfactory; cough; sore throat) whose pharyngeal or oral swabs were positive for SARS Cov2 RT PCR: were randomly divided into two groups. The first group received 50 mg three times daily for levamisole and the second group received placebo.
Main outcome variables
The course of the disease; the need for hospitalization; changes in CT scan and when RT PCT is negative are compared in both groups. The starting point for complete recovery is with negative RT PCR or need for hospitalization. Patients are also screened for mortality requiring ECU, length of hospital stay, renal complications, and exacerbation of symptoms on CT scan.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131215015805N2
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Payam Peymani
Name of organization / entity
Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 9615
Email address
peymanip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of levamisole on pneumonia caused by COVID-19
Public title
Assessment of effect of levamisole on pneumonia caused by COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 Patients moderate Lung Complication informed consent
Exclusion criteria:
Patients with WBC COUNT <6000 Platelet less than 100 thousand Patients with immune diseases Previous respiratory diseases Cancer Pregnancy Breast Feeding immunosuppressive medication organ transplant autoimmune disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 25
after randomization, 25 patients alocated for each group.
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomized into two groups at a ratio of 1:1 using random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
this a double-blinded study. patients and caregivers will be blinded. intervention and placebo agent will be given a caregiver according to the randomization protocol.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Cmmitte, Shiraz University of Medical Sciences
Street address
zand street,Shiraz University of Medical Sciences,7th floor
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.SUMS.REC.1399.178

Health conditions studied

1

Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Prevent the development of pneumonia caused by Convid19
Timepoint
one week
Method of measurement
CT scan

2

Description
Reduce the need for hospitalization
Timepoint
two week
Method of measurement
Measure the length of hospital stay

3

Description
Death
Timepoint
2 to 3 week
Method of measurement
Measuring mortality

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: 50 mg three times daily for levamisole for 5 days
Category
Treatment - Drugs

2

Description
Control group: Like levamisole, placebo will be given three times a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital in Shiraz
Full name of responsible person
Dr mohsen moghadami
Street address
meshkin fam street
City
Shiraz
Province
Fars
Postal code
۳۲۲۸۸۹۰۷
Phone
+98 71 3228 8602
Email
m_moghadami@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohsen Moghaddami
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 2093
Email
m_moghadami@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Payam Peymani
Position
Assistant Professor and Director of Pharmacoepidemiology andPharmacoeconomics Group, Health Policy R
Latest degree
Ph.D.
Other areas of specialty/work
pharmacoepidemiology
Street address
zand street
City
Shiraz
Province
Fars
Postal code
71345-1877
Phone
+98 71 3230 9615
Email
peymani.payam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamran Bagheri Lankarani
Position
Distinguished Professor of Medicine Director Health Policy Research Center Shiraz University of Medi
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
zand street
City
Shiraz
Province
Fars
Postal code
71345-1877
Phone
+98 71 3230 9615
Email
kblankarani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Payam Peymani
Position
Pharm.D, PhD Student in Pharmacoepidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Health Policy Research Center, School of Medicine, Zand Avenue, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71345-1877,
Phone
+98 71 1230 9615
Fax
Email
peymanip@sums.ac.ir
Web page address

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
Statistical Results
When the data will become available and for how long
6 month after the project completion
To whom data/document is available
By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers
Under which criteria data/document could be used
The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee
From where data/document is obtainable
To researchers responsible for responding to this plan
What processes are involved for a request to access data/document
Written request Coordinated by the ethics committee 2 months
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