Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19

NCT04360122 | Unknown Phase 3 DMC

• 1 other identifier: FMASU P20a/ 2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.

Conditions

Coronavirus Disease (COVID-19)

Keywords

Egypt

Outcome Measures

Primary Outcomes (1)

• Decrease the incidence of COVID-19 infection or its severity

  Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection

  6 months

Study Arms (4)

Levamisole

ACTIVE COMPARATOR

Oral Levamisole 150 mg/day for two days per week for two months

Drug: Levamisole

Isoprinosine

ACTIVE COMPARATOR

Oral Isoprinosine 1 g 3 times per day daily for two months

Drug: Isoprinosine

Levamisole and Isoprinosine

ACTIVE COMPARATOR

Oral Levamisole 150 mg/day for two days per week and Oral Isoprinosine 1 g 3 times per day daily for two months

Drug: Levamisole and Isoprinosine

Non-interventional group

NO INTERVENTION

No-intervention

Interventions

Levamisole DRUG

Levamisole (150 mg/day for two days per week for 2 months

Levamisole

Isoprinosine DRUG

Isoprinosine (1 g 3 times per day daily) for two months

Isoprinosine

Levamisole and Isoprinosine DRUG

Levamisole (150 mg/day for two days per week for 2 months and Isoprinosine (1 g 3 times per day daily) for two months

Levamisole and Isoprinosine

Eligibility Criteria

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

You may qualify if:

• Adult \> 18 years old
• Both Gender (male and female)
• Healthy health care workers employed by one of the hospitals involved in the study
• Negative serology at day 0 for COVID19 infection.
• Evidence of a personally signed and dated informed consent document

You may not qualify if:

• Participations in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection
• Previous or recent COVID 19 infection (previously had a SARS-CoV-2 positive test result or confirmed case of SARS-CoV-2 infection or positive serology at day 0)
• Any medical illness
• Has a congenital immunodeficiency, including specific deficiencies of the interferon-gamma pathway
• Participants receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
• Participants who have received any other immunotherapy.
• Participants with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction and severe gastric ulcer.
• Participants receiving allopurinol, indomethacin, colchicine or diuretics.
• Participants with hematological problems.
• Known hypersensitivity reactions or Wheat Allergy
• Pregnant and lactating females.
• Refusal to sign the informed consent form
• Refusal of participation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11566, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Levamisole; Inosine Pranobex

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mariam Amin, MD

CONTACT

01224532769; mariamaged@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Allergy and Clinical Immunology.Faculty of Medicine Ain Shams University

Model Details: Phase III, randomized, open labelled, clinical trial on one hundred adult healthy healthcare workers

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: May 20, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)