Corona virus
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteer Age 18-65 Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding 2. Contra-indication to hydroxychloroquine or quinine (Allergic reaction, prolonged QTc-interval (> 450 msec), long-QT syndrome (LQTS), retinopathy, epilepsia, myasthenia gravis, G6PD-deficiency) 3. Concurrent use of amiodarone, ciclosporin, digoxin, erythromycin (daily dose > 1000 mg), ritonavir, sotalol, tamoxifen or tranylcypromine 4. COVID-19 like symptoms, such as fever, couch, or sore throat; only by history taking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The local tolerability of the inhalation of dry powder hydroxychloroquine defined by a drop of forced expiratory volume in 1 second (FEV1) of >15% (lung function measurement) and any other reported adverse events. For the local tolerability of the inhalation of dry powder hydroxychloroquine the drop of forced expiratory volume in 1 second (FEV1) of >15% (lung function measurement) and any other reported adverse event are all considered critical to decide on proceeding into a phase 2B (and/or a phase 3) trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| The inspiratory parameters during the inhalation maneuver are critical to explore predictors for drug exposure. The following parameters will be calculated: dPmax (maximum pressure drop), Vi (inhaled volume), Ti (total inhalation time), PIF (peak inspiratory flow rate), MIF (mean inspiratory flow rate) and the FIR (average flow increase rate between 20% and 80% of PIF). Actual inhaled dose (dose minus remainder in inhaler after inhalation) will be calculated and blood samples will be drawn predose, at 0.5, 2 and 3.5 hrs after inhalation. | — |
Countries
Netherlands
Outcome results
None listed