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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04477083
Recruitment Status : Unknown
Verified July 2020 by Ibrahim M. El-Sherbiny, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Information provided by (Responsible Party):
Ibrahim M. El-Sherbiny, 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.

Condition or disease Intervention/treatment Phase
Covid19 Hydroxychloroquine Adverse Reaction Drug: inhalable hydroxychloroquine (HCQ) Drug: supportive and symptomatic treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The first 20 consecutive patients (group A) will be treated by oral antibiotics, supportive treatment and inhalable hydroxychloroquine (HCQ). (In day 1, an inhaled hydroxychloroquine sulfate dose of 12 mg will be taken via nebulization three times/day (TID) as a loading dose. Then, starting from day 2, same dose of 12 mg of inhaled hydroxychloroquine will be taken twice/day (BID) as maintenance dose for 5 days. The subsequent 20 consecutive patients (group B) will receive the same treatment of group A but without inhalable hydroxychloroquine (HCQ). At day 7, all patients of both groups will be evaluated by clinical, laboratory and chest CT parameters. Patients of group B who still show no clinical, laboratory or radiological improvement will continue treatment by adding inhalable hydroxychloroquine (HCQ). for another 7 days and re-evaluated at day 14. Patients of group A who still show no significant improvement at day 7 only will be re-checked at day 14.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: inhalable hydroxychloroquine (HCQ).
supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).
Drug: inhalable hydroxychloroquine (HCQ)
inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment

Placebo Comparator: Placebo
supportive and symptomatic treatment
Drug: supportive and symptomatic treatment
supportive and symptomatic treatment

Primary Outcome Measures :
  1. Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs [ Time Frame: 15 days ]
    Time is measured in hours

  2. Time to achieve viral clearance state determined by two successive negative PCR results for two oropharyngeal swabs separated by 48 hours. [ Time Frame: 15 days ]
    Time is measured in hours

Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 15 days ]
    measuring and monitoring the complication between groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04477083

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Mansoura University Hospital
Mansoura, Outside U.S./Canada, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Responsible Party: Ibrahim M. El-Sherbiny, PHD, Mansoura University Identifier: NCT04477083    
Other Study ID Numbers: inhalable HCQ
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ibrahim M. El-Sherbiny, Mansoura University:
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents