Clinical Trials Logo

Clinical Trial 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.


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of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)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


Related Conditions & MeSH terms


NCT number NCT04360122
Study type Interventional
Source Ain Shams University
Contact Mariam Amin, MD
Phone 01224532769
Email mariamaged@yahoo.com
Status Not yet recruiting
Phase Phase 3
Start date May 20, 2020
Completion date December 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT04583982 - ImmuneSense™ COVID-19 Study
Completed NCT04609774 - Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus of Coronavirus Disease 2019
Terminated NCT04569786 - Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) Phase 1
Completed NCT04575597 - Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) Phase 2/Phase 3
Terminated NCT04575584 - Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001) Phase 2/Phase 3
Recruiting NCT04572360 - Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients N/A
Recruiting NCT04885361 - To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults Phase 1
Completed NCT05119855 - Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076) Phase 3
Completed NCT04558307 - Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations
Recruiting NCT04584606 - Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients
Completed NCT04677660 - A Study of TAK-919 in Healthy Japanese Adults (COVID-19) Phase 1/Phase 2
Withdrawn NCT04280588 - Fingolimod in COVID-19 Phase 2
Completed NCT04941144 - Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
Terminated NCT04498247 - A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) Phase 1/Phase 2
Completed NCT04939428 - Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) Phase 3
Withdrawn NCT04892888 - Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms
Completed NCT04348214 - Screening & Risk Assessment of Healthcare Workers & Infection Control in University & COVID-19 Quarantine Hospitals
Not yet recruiting NCT04348877 - Plasma Rich Antibodies From Recovered Patients From COVID19 N/A
Not yet recruiting NCT04346043 - To Access the Egyptian COVID-19 Whole Genome by NGS and Compare to the International Worldwide Database
Not yet recruiting NCT04350931 - Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19 Phase 3