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

NCT ID: NCT04383717

Last Updated: 2020-05-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-10-30

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

Conditions

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Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Proposed treatment group

Levamisole and isoprinosine

Group Type ACTIVE_COMPARATOR

Levamisole and isoprinosine

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Azithromycin and hydroxychloroquine

Intervention Type DRUG

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

Intervention Type DRUG

Azithromycin and hydroxychloroquine

oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily

Intervention Type DRUG

Other Intervention Names

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ketrax and inosiplex Zithromax and plaquinel

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hagar El Sayed

Dermatology Lecturer Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed El Darouti, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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Hagar El Sayed, MD

Role: CONTACT

0223682030

Mohamed El Darouti, Professor

Role: CONTACT

0223682030

Other Identifiers

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Levamisole and isoprinosine

Identifier Type: -

Identifier Source: org_study_id

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