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

Not Applicable

• Conditions: Hydroxychloroquine Adverse Reaction; Covid19
• Interventions: Drug: supportive and symptomatic treatment; Drug: inhalable hydroxychloroquine (HCQ)

• Registration Number: NCT04477083
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study Start: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	supportive and symptomatic treatment	supportive and symptomatic treatment
inhalable hydroxychloroquine (HCQ).	inhalable hydroxychloroquine (HCQ)	supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).

Primary Outcome Measures

Name	Time	Method
Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs	15 days	Time is measured in hours
Time to achieve viral clearance state determined by two successive negative PCR results for two oropharyngeal swabs separated by 48 hours.	15 days	Time is measured in hours

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	15 days	measuring and monitoring the complication between groups

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Outside U.S./Canada, Egypt