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

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Respiratory Tract Infections

Treatments: Drug: Azithromycin and hydroxychloroquine; Drug: Levamisole and isoprinosine

Study type: Interventional

Funder types: Other

Identifiers

NCT04383717

Levamisole and isoprinosine

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Proposed treatment group

Active Comparator group

Description:

Levamisole and isoprinosine

Treatment:

Drug: Levamisole and isoprinosine

Control group

Active Comparator group

Description:

hydroxychloroquine and azithromycin

Treatment:

Drug: Azithromycin and hydroxychloroquine