Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19

NCT ID: NCT04477083

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2020-08-15

Brief Summary

In this project, we aimed at developing new "Ready-to-Use" inhalable forms of HCQ that can be used directly through nebulization or using dry powder inhalers (DPIs). These inhaled forms would allow a simple and direct delivery of the drug (HCQ) specifically towards the throat and the lung which are the main sites for the COVID-19 viral infection. Hence, the drug can be available at higher concentrations in the throat and lungs as compared with the currently used treatment protocols, while minimizing the drug systemic concentrations and its presence in other body organs, and thus enhancing the drug efficacy with significantly limiting its side effects. Besides, using inhalable forms can be more convenient to patients suffering from gastrointestinal complications from the disease that can limit the absorption of oral forms. Moreover, the proposed inhalable forms are designed in such a way to hide the drug from the immune system (confer stealth characteristics) using FDA-approved excipients to minimize/avoid any immune response towards the drug as was noted towards it in its oral form that's used in the treatment protocol of COVID-19. In addition, the inhaled formulations will be designed to maintain the overall simplicity and scalability of the preparation which is critical during this urgent pandemic situation. The cost of the final formulation is also taken into consideration since the drug is intended for treatment of thousands or probably millions of patients around the world including countries with limited economic capabilities.

Conditions

Covid19; Hydroxychloroquine Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

inhalable hydroxychloroquine (HCQ).

supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).

Group Type: ACTIVE_COMPARATOR

inhalable hydroxychloroquine (HCQ)

Intervention Type: DRUG

inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment

Placebo

supportive and symptomatic treatment

Group Type: PLACEBO_COMPARATOR

supportive and symptomatic treatment

Intervention Type: DRUG

supportive and symptomatic treatment

Interventions

inhalable hydroxychloroquine (HCQ)

inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment

Intervention Type: DRUG

supportive and symptomatic treatment

supportive and symptomatic treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 year
• Laboratory (RT-PCR) positive of SARS-COV-2 (Moderate cases)
• Chest CT with pneumonia.
• SaO2/SPO2 ratio > 93% or PaO2/FIO2 ratio > 300 mmHg under the condition in the hospital room.
• Welling to participate and able to give fully informed consent

Exclusion Criteria

• Severe and critical illness.
• Retinopathy and other retinal diseases.
• Arrhythmias.
• QT ≥ 400 msec
• Receiving cardiac drugs
• Severe liver disease.
• Pregnancy or lactation.
• Previous treatment of COVID-19.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim M. El-Sherbiny

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Hospital

Al Mansurah, Outside U.S./Canada, Egypt

Countries

Egypt

Other Identifiers

inhalable HCQ

Identifier Type: -

Identifier Source: org_study_id