NCT04360122

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection) 2.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

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-20
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2020-04-24
• Last updated: 2020-05-05

Locations

1 site across 1 country: Egypt