Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 15, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date May 5, 2020
Estimated Study Start Date  ICMJE May 20, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
Official Title  ICMJE Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Coronavirus Disease (COVID-19)
Intervention  ICMJE
  • Drug: Levamisole
    Levamisole (150 mg/day for two days per week for 2 months
  • Drug: Isoprinosine
    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
Study Arms  ICMJE
  • Active Comparator: Levamisole
    Oral Levamisole 150 mg/day for two days per week for two months
    Intervention: Drug: Levamisole
  • Active Comparator: Isoprinosine
    Oral Isoprinosine 1 g 3 times per day daily for two months
    Intervention: Drug: Isoprinosine
  • 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
    Intervention: Drug: Levamisole and Isoprinosine
  • No Intervention: Non-interventional group
    No-intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mariam Amin, MD 01224532769 ext 002 mariamaged@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04360122
Other Study ID Numbers  ICMJE FMASU P20a/ 2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maged Mohammed Refaat, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP