Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Primary Purpose
Coronavirus Disease (COVID-19)
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Levamisole
Isoprinosine
Levamisole and Isoprinosine
Sponsored by
About this trial
This is an interventional prevention trial for Coronavirus Disease (COVID-19) focused on measuring Egypt
Eligibility Criteria
Inclusion Criteria:
- Adult > 18 years old
- Both Gender (male and female)
- Healthy health care workers employed by one of the hospitals involved in the study
- Negative serology at day 0 for COVID19 infection.
- Evidence of a personally signed and dated informed consent document
Exclusion Criteria:
- Participations in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection
- Previous or recent COVID 19 infection (previously had a SARS-CoV-2 positive test result or confirmed case of SARS-CoV-2 infection or positive serology at day 0)
- Any medical illness
- Has a congenital immunodeficiency, including specific deficiencies of the interferon-gamma pathway
- Participants receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
- Participants who have received any other immunotherapy.
- Participants with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction and severe gastric ulcer.
- Participants receiving allopurinol, indomethacin, colchicine or diuretics.
- Participants with hematological problems.
- Known hypersensitivity reactions or Wheat Allergy
- Pregnant and lactating females.
- Refusal to sign the informed consent form
- Refusal of participation
Sites / Locations
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Levamisole
Isoprinosine
Levamisole and Isoprinosine
Non-interventional group
Arm Description
Oral Levamisole 150 mg/day for two days per week for two months
Oral Isoprinosine 1 g 3 times per day daily for two months
Oral Levamisole 150 mg/day for two days per week and Oral Isoprinosine 1 g 3 times per day daily for two months
No-intervention
Outcomes
Primary Outcome Measures
Decrease the incidence of COVID-19 infection or its severity
Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04360122
Brief Title
Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Official Title
Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.
Detailed Description
One hundred healthy health workers will be randomly assigned to receive either Levamisole, Isoprinosine, Levamisole and Isoprinosine or no-intervention for two months. Written informed consent will be obtained from all participants.
During the study:
Participants will be assessed by detailed questionnaire, clinically and laboratory investigations for COVID 19 Detailed questionnaire for: job description, site of isolation hospital, duration of contact, time of exposure, methods of protection Clinically for any symptoms suggestive of COVID19: fever, plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)
Assessment of the modulatory effect of the drugs will be done by one or more of the following parameters: (at beginning of the study, 2 weeks, 1 month, 2-month, 3 month)
Neutrophil function test
Natural killer cell count and activity.
T cell count and B cell subsets by flowcytometry and activity markers
Quantitative immunoglobulines Levels (IgG, IgM, IgA, IgE)
Assessment of the drug safety at beginning of the study and every two weeks except for complete blood count every week:
Urine analysis
Complete blood count with differential to determine total white blood cell count, absolute neutrophilic count (to exclude agranulocytosis) and absolute lymphocytic count (for COVID19).
Serum uric acid
Renal functions tests
Liver function tests
Randomization method:
A block-randomization scheme will be generated by computer software. Computer-generated random numbers will randomize the participants into four intervention groups of 25 each. The patients were randomly assigned to receive either Isoprinosine (1 g 3 times per day daily) or Levamisole (150 mg/day for two days per week), both or no-intervention for two months.
End point of the study:
Refusal of patient to complete the study.
Non-compliance on treatment
Agranulocytosis or thrombocytopenia.
Hyperuricemia.
COVID19 infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease (COVID-19)
Keywords
Egypt
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase III, randomized, open labelled, clinical trial on one hundred adult healthy healthcare workers
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levamisole
Arm Type
Active Comparator
Arm Description
Oral Levamisole 150 mg/day for two days per week for two months
Arm Title
Isoprinosine
Arm Type
Active Comparator
Arm Description
Oral Isoprinosine 1 g 3 times per day daily for two months
Arm Title
Levamisole and Isoprinosine
Arm Type
Active Comparator
Arm Description
Oral Levamisole 150 mg/day for two days per week and Oral Isoprinosine 1 g 3 times per day daily for two months
Arm Title
Non-interventional group
Arm Type
No Intervention
Arm Description
No-intervention
Intervention Type
Drug
Intervention Name(s)
Levamisole
Intervention Description
Levamisole (150 mg/day for two days per week for 2 months
Intervention Type
Drug
Intervention Name(s)
Isoprinosine
Intervention Description
Isoprinosine (1 g 3 times per day daily) for two months
Intervention Type
Drug
Intervention Name(s)
Levamisole and Isoprinosine
Intervention Description
Levamisole (150 mg/day for two days per week for 2 months and Isoprinosine (1 g 3 times per day daily) for two months
Primary Outcome Measure Information:
Title
Decrease the incidence of COVID-19 infection or its severity
Description
Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult > 18 years old
Both Gender (male and female)
Healthy health care workers employed by one of the hospitals involved in the study
Negative serology at day 0 for COVID19 infection.
Evidence of a personally signed and dated informed consent document
Exclusion Criteria:
Participations in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection
Previous or recent COVID 19 infection (previously had a SARS-CoV-2 positive test result or confirmed case of SARS-CoV-2 infection or positive serology at day 0)
Any medical illness
Has a congenital immunodeficiency, including specific deficiencies of the interferon-gamma pathway
Participants receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
Participants who have received any other immunotherapy.
Participants with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction and severe gastric ulcer.
Participants receiving allopurinol, indomethacin, colchicine or diuretics.
Participants with hematological problems.
Known hypersensitivity reactions or Wheat Allergy
Pregnant and lactating females.
Refusal to sign the informed consent form
Refusal of participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Amin, MD
Phone
01224532769
Ext
002
Email
mariamaged@yahoo.com
Facility Information:
Facility Name
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
City
Cairo
State/Province
Non-US
ZIP/Postal Code
11566
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Soliman E Ebeid
Phone
01095569596
Email
dr.fatma_ebeid@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
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