- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360122
Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
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of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)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
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mariam Amin, MD
- Phone Number: 002 01224532769
- Email: mariamaged@yahoo.com
Study Locations
-
-
Non-US
-
Cairo, Non-US, Egypt, 11566
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Levamisole
Oral Levamisole 150 mg/day for two days per week for two months
|
Levamisole (150 mg/day for two days per week for 2 months
|
Active Comparator: Isoprinosine
Oral Isoprinosine 1 g 3 times per day daily for two months
|
Isoprinosine (1 g 3 times per day daily) for two months
|
Active Comparator: Levamisole and Isoprinosine
Oral Levamisole 150 mg/day for two days per week and Oral Isoprinosine 1 g 3 times per day daily for two months
|
Levamisole (150 mg/day for two days per week for 2 months and Isoprinosine (1 g 3 times per day daily) for two months
|
No Intervention: Non-interventional group
No-intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease the incidence of COVID-19 infection or its severity
Time Frame: 6 months
|
Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Levamisole
- Inosine Pranobex
Other Study ID Numbers
- FMASU P20a/ 2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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