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

• Status: Not yet recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Inosine Pranobex; Levamisole

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