Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
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|ClinicalTrials.gov Identifier: NCT04360122|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease (COVID-19)||Drug: Levamisole Drug: Isoprinosine Drug: Levamisole and Isoprinosine||Phase 3|
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:
- 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of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)
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)
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
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.
- COVID19 infection
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|Official Title:||Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19|
|Estimated Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Active Comparator: Levamisole
Oral Levamisole 150 mg/day for two days per week for two months
Levamisole (150 mg/day for two days per week for 2 months
Active Comparator: Isoprinosine
Oral Isoprinosine 1 g 3 times per day daily for two months
Isoprinosine (1 g 3 times per day daily) for two months
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
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
No Intervention: Non-interventional group
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360122
|Contact: Mariam Amin, MD||01224532769 ext firstname.lastname@example.org|
|Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center|
|Cairo, Non-US, Egypt, 11566|
|Contact: Fatma Soliman E Ebeid 01095569596 email@example.com|