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Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360122
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Maged Mohammed Refaat, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Drug: Levamisole Drug: Isoprinosine Drug: Levamisole and Isoprinosine Phase 3

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:

  1. 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of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)
  2. 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)
  3. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, randomized, open labelled, clinical trial on one hundred adult healthy healthcare workers
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Estimated Study Start Date : May 20, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Active Comparator: Levamisole
Oral Levamisole 150 mg/day for two days per week for two months
Drug: Levamisole
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
Drug: Isoprinosine
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
Drug: Levamisole and Isoprinosine
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360122


Contacts
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Contact: Mariam Amin, MD 01224532769 ext 002 mariamaged@yahoo.com

Locations
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Egypt
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566
Contact: Fatma Soliman E Ebeid    01095569596    dr.fatma_ebeid@yahoo.com   
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Maged Mohammed Refaat, Professor of Allergy and Clinical Immunology.Faculty of Medicine Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT04360122    
Other Study ID Numbers: FMASU P20a/ 2020
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maged Mohammed Refaat, Ain Shams University:
Egypt
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Levamisole
Inosine Pranobex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Antiviral Agents