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

Phase 3

• Conditions: Respiratory Tract Infections
• Interventions: Drug: Azithromycin and hydroxychloroquine; Drug: Levamisole and isoprinosine

• Registration Number: NCT04383717
• Lead Sponsor: Cairo University

Brief Summary

The use of both levamisole \& Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection

Detailed Description

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

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study Start: 2020-05-05
• Study First Submitted QC: 2020-05-10
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-13
• Primary Completion: 2020-08-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Azithromycin and hydroxychloroquine	hydroxychloroquine and azithromycin
Proposed treatment group	Levamisole and isoprinosine	Levamisole and isoprinosine

Primary Outcome Measures

Name	Time	Method
COVID 19 induced dyspnea in both groups	4 weeks	improvement of dyspnea by normalization of respiratory rate
COVID 19 induced fever in both groups	4 weeks	Improvement of fever in degrees celsius
COVID 19 viral load in both groups	4 weeks	PCR of COVID 19 changes from positive to negative

Secondary Outcome Measures

Name	Time	Method
laboratory clearance in both groups: CRP in mg/dL	4 weeks	CRP in mg/dL