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

NCT04383717 | Unknown Phase 3

• 1 other identifier: Levamisole and isoprinosine
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Respiratory Tract Infections

Keywords

Levamisole; Isoprinosine; COVID19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• laboratory clearance in both groups: CRP in mg/dL

  4 weeks

Study Arms (2)

Proposed treatment group

ACTIVE COMPARATOR

Levamisole and isoprinosine

Drug: Levamisole and isoprinosine

Control group

ACTIVE COMPARATOR

hydroxychloroquine and azithromycin

Drug: Azithromycin and hydroxychloroquine

Interventions

Levamisole and isoprinosine 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

Also known as: ketrax and inosiplex

Proposed treatment group

Azithromycin and hydroxychloroquine DRUG

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

Also known as: Zithromax and plaquinel

Control group

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Respiratory Tract Infections; COVID-19

Interventions

Levamisole; Inosine Pranobex; Azithromycin; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Erythromycin; Macrolides; Polyketides; Lactones; Chloroquine; Aminoquinolines; Quinolines

Study Officials

• Mohamed El Darouti, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagar El Sayed, MD

CONTACT

0223682030; hgr_ntr@yahoo.com

Mohamed El Darouti, Professor

CONTACT

0223682030

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Lecturer Cairo University

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 12, 2020
• Study Start: May 5, 2020
• Primary Completion: August 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share