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

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

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

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Drug: Levamisole and isoprinosine; Drug: Azithromycin and hydroxychloroquine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proposed treatment group; Levamisole and isoprinosine	Drug: 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; Other Names: ketrax and inosiplex
Active Comparator: Control group; hydroxychloroquine and azithromycin	Drug: Azithromycin and hydroxychloroquine; oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily; Other Names: Zithromax and plaquinel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed El Darouti, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 5, 2020
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID19; Levamisole; Isoprinosine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunologic Factors; Anti-Bacterial Agents; Adjuvants, Immunologic; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Antinematodal Agents; Anthelmintics; Azithromycin; Hydroxychloroquine; Levamisole; Inosine Pranobex
• Other Study ID Numbers: Levamisole and isoprinosine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No