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

Mansoura University

Status: Unknown

Conditions: Hydroxychloroquine Adverse Reaction; Covid19

Treatments: Drug: inhalable hydroxychloroquine (HCQ); Drug: supportive and symptomatic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04477083

inhalable HCQ

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

inhalable hydroxychloroquine (HCQ).

Active Comparator group

Description:

supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).

Treatment:

Drug: inhalable hydroxychloroquine (HCQ)

Placebo

Placebo Comparator group

Description:

supportive and symptomatic treatment

Treatment:

Drug: supportive and symptomatic treatment