Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
NCT ID: NCT04383717
Last Updated: 2020-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2020-05-05
2020-10-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Proposed treatment group
Levamisole and isoprinosine
Levamisole and isoprinosine
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
Control group
hydroxychloroquine and azithromycin
Azithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
Interventions
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Levamisole and isoprinosine
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
Azithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical picture of COVID 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose
Exclusion Criteria
* 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
6 Years
90 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hagar El Sayed
Dermatology Lecturer Cairo University
Principal Investigators
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Mohamed El Darouti, Professor
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Central Contacts
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Mohamed El Darouti, Professor
Role: CONTACT
Other Identifiers
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Levamisole and isoprinosine
Identifier Type: -
Identifier Source: org_study_id
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