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

NCT04477083 | Unknown

• 1 other identifier: inhalable HCQ
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Hydroxychloroquine Adverse Reaction

Keywords

Covid19; Hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• Time to clinical recovery defined as 3 days afebrile with improved cough and other clinical signs

  Time is measured in hours

  15 days

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  15 days

Study Arms (2)

inhalable hydroxychloroquine (HCQ).

ACTIVE COMPARATOR

supportive and symptomatic treatment and inhalable hydroxychloroquine (HCQ).

Drug: inhalable hydroxychloroquine (HCQ)

Placebo

PLACEBO COMPARATOR

supportive and symptomatic treatment

Drug: supportive and symptomatic treatment

Interventions

inhalable hydroxychloroquine (HCQ) DRUG

inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment

inhalable hydroxychloroquine (HCQ).

supportive and symptomatic treatment DRUG

supportive and symptomatic treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: July 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

EG (1)