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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04477083
• Other study ID #: inhalable HCQ
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: July 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Hydroxychloroquine Adverse Reaction

Intervention

Drug:
• inhalable hydroxychloroquine (HCQ)
inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment
• supportive and symptomatic treatment
supportive and symptomatic treatment

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs	Time is measured in hours	15 days
Primary	Time to achieve viral clearance state determined by two successive negative PCR results for two oropharyngeal swabs separated by 48 hours.	Time is measured in hours	15 days
Secondary	Incidence of Treatment-Emergent Adverse Events	measuring and monitoring the complication between groups	15 days