COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8726

M. Moerland

clintrials@chdr.nl

2020-06-23

Recruiting

nonRCT

Non-randomized

Parallel

Blind label

unclear

Prevention

1. Healthy male subjects, 18 to 30 years or 65 to 70 years of age, inclusive at screening. 2. Body mass index (BMI) between 18 and 28 kg/m2, inclusive, and with a minimum weight of 50 kg.3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions

1. Known hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines,2. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator, following a detailed medical history (including a known history of long QT syndrome, known history of retinal disease, G6PD deficiency, porphyria, psoriasis, myasthenia gravis, liver disease, diabetes mellitus type I and II, existing hearing loss, and current or revious history of a relevant psychiatric disorder ie. major depressive disorder, bipolar disorder, schizophrenia or another psychotic disorder or current of previous suicidality irrespective of an associated psychiatric disorder),3. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects,4. Signs or symptoms of any active infection within two weeks prior to first dosing.5. Positive SARS-CoV-2 qPCR test pre-dose.6. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening,7. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg and considered to be of clinical relevance by the investigator,8. Abnormal findings in the resting ECG, including but not limited to QTcF> 450 msec.9. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator,10. Participation in an investigational drug study (last dosing of previous study was within 90 days prior to first dosing of this study),11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent and unable to abstain from alcohol use from at least 24 hours before every visit,12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may be repeated,13. Smoker of more than 10 cigarettes per week prior to screening or who use tobacco products equivalent to more than 10 cigarettes per week and unable to abstain from smoking from at least 7 days before first dosing until the last return visit (day 10),14. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable),15. Loss or donation of blood over 500 mL within three months prior to screening or intention to donate blood or blood products during the study,16. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

2

CHDR

18

100

Netherlands

Healthy volunteers

N/A

40

Pharmacokinetic endpoints- Hydroxychloroquine plasma concentration- Hydroxychloroquine whole blood concentration Pharmacodynamic endpoints- Endosomal TLR responseso TLR3-driven cytokine production o TLR7-driven cytokine productiono TLR8-driven cytokine productiono TLR9-driven cytokine production- T cell responseso Proliferation o Activation marker expressiono Cytokine production - B cell responseso Activation marker expressiono Proliferation- Leukocyte differentiation - Flow cytometry phenotyping of dendritic cells; monocytes; T cells and B cells

Not reported

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]