Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial

Study Overview
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Brief Summary
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The use of both levamisole & Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection

Detailed Description
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Study design: Randomized controlled trial, randomization by closed envelope technique Informed consent will be written for each patient of either group At the beginning of the study all patients will have the following investigations done: CBC with differential, ESR, PCR for COVID 19, D dimer and CT chest and confirmed cases will included in the study Pregnant and lactating women together with children with other comorbidities will be excluded from the study Study groups: Duration of the study is 4 weeks Both groups with persistent COVID 19 symptoms that require hospitalization Group 1: 30 patients with confirmed COVID19 infection and sharing clinical features like fever, malaise, sore throat, runny nose, persistent cough &dyspnea, requiring hospitalization Group 2: control group: 30 patients Treatment endpoint • Cure of patients: Improvement of symptoms Laboratory findings ESR and total leucocytic count returning to normal PCR negative Radiological improvement • Worsening of symptoms or fatalities

Official Title
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The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Drug: Levamisole and isoprinosine
* Drug: Azithromycin and hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID 19 infection (positive PCR, elevated ESR, leucopenia) Clinical picture of COVID 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose Exclusion Criteria: Mild cases of COVID 19 that do not require hospitalization Pregnant & lactating women Children with other comorbidities People who received previous treatment for COVID 19 in the last 2 weeks N.B. Diabetes and hypertension not excluded

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proposed treatment group<br>Levamisole and isoprinosine | Drug: Levamisole and isoprinosine<br>* oral tablets levamisole 50 mg 3 times daily every other day for 2 weeks Isoprinosine oral tablets 1 g 4 times daily for 2 weeks<br>* Other names: ketrax and inosiplex;|
| Active Comparator: Control group<br>hydroxychloroquine and azithromycin | Drug: Azithromycin and hydroxychloroquine<br>* oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily<br>* Other names: Zithromax and plaquinel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 induced fever in both groups | Improvement of fever in degrees celsius | 4 weeks | 
| COVID 19 induced dyspnea in both groups | improvement of dyspnea by normalization of respiratory rate | 4 weeks | 
| COVID 19 viral load in both groups | PCR of COVID 19 changes from positive to negative | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory clearance in both groups: CRP in mg/dL | CRP in mg/dL | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levamisole, Isoprinosine, COVID19