Controlled clinical trial of hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting

Porin kaupunki0 sites600 target enrollmentJune 26, 2020

Overview

No summary available.

Registry

who.int

Start Date

June 26, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Porin kaupunki

•1\. Subjects over 40 years of age, or 18\-40 years of age with one or both of the following:
•a. diabetes mellitus (type 1 or type 2\)
•b. BMI \> 35 kg/m2\.
•2\. Subjects capable of providing independent informed consent and signing the informed consent form (the subjects’ capacity to consent should be determined in accordance with applicable professional standards and will be based on the investigator's judgment).
•3\. Subjects with symptoms typical of Covid\-19 infection, according to criteria specified in the study protocol, with or without known or suspected exposure to the SARS\-CoV\-2 virus. The onset of symptoms must be within 5 days of enrolment. Study medication may only be started once a positive SARS\-CoV\-2 PCR test results of a nasopharyngeal swab sample is available; if the first PCR test result is negative, a second sample may be collected and analyzed.
•4\. Female subjects of child\-bearing potential must agree to employ a reliable method of contraception until three months after start of IMP intake.
•5\. Subject must agree not to share medication with the others.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Subjects with suspected severe or moderately severe pneumonia, presenting with any of the following: respiratory rate \> 26 breaths/min; significant respiratory distress; or SpO2 \=94 % on room air;
•2\. Subjects requiring treatment in the hospital, according to the treating physician’s judgement;
•3\. Subjects having any contraindication to treatment with HCQ, such as a long QTc interval (\>450 ms in men, \>470 ms in women), porphyria, epilepsy, severe renal insufficiency;
•4\. Screening 12\-lead ECG results showing evidence of clinically significant disturbances of cardiac rhythm or impulse conduction. Atrial fibrillation, paroxysmal supraventricular tachycardia or supraventricular extrasystoles are not exclusionary;
•5\. Cardiac insufficiency of NYHA Class 3\-4;
•6\. History of stroke, within 6 months of screening;
•7\. Subjects with a history of seizures within one year of screening;
•8\. Subjects with a history of drowning accident;
•9\. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions, schizophrenia, bipolar disorder) that, in the opinion of the investigator, could interfere with study procedures or assessments or subject safety;
•10\. Disorder related to alcohol or drug abuse, as defined in DSM\-5\-TR, within one year prior to screening;