Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19
Primary Purpose
Covid19, Hydroxychloroquine Adverse Reaction
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
inhalable hydroxychloroquine (HCQ)
supportive and symptomatic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, Hydroxychloroquine
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.
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
inhalable hydroxychloroquine (HCQ).
Placebo
Arm Description
supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).
supportive and symptomatic treatment
Outcomes
Primary Outcome Measures
Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs
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.
Time is measured in hours
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
measuring and monitoring the complication between groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04477083
Brief Title
Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19
Official Title
Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 15, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hydroxychloroquine Adverse Reaction
Keywords
Covid19, Hydroxychloroquine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inhalable hydroxychloroquine (HCQ).
Arm Type
Active Comparator
Arm Description
supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
supportive and symptomatic treatment
Intervention Type
Drug
Intervention Name(s)
inhalable hydroxychloroquine (HCQ)
Intervention Description
inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment
Intervention Type
Drug
Intervention Name(s)
supportive and symptomatic treatment
Intervention Description
supportive and symptomatic treatment
Primary Outcome Measure Information:
Title
Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs
Description
Time is measured in hours
Time Frame
15 days
Title
Time to achieve viral clearance state determined by two successive negative PCR results for two oropharyngeal swabs separated by 48 hours.
Description
Time is measured in hours
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
measuring and monitoring the complication between groups
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19
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