Status:

UNKNOWN

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

Lead Sponsor:

Ain Shams University

Conditions:

Coronavirus Disease (COVID-19)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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, Isoprin...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 20 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04360122

Start Date

May 20 2020

End Date

December 1 2020

Last Update

May 5 2020

Active Locations (1)

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Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt, 11566