This is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection. The study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of SARS-CoV-2 pneumonia in patients who will be hospitalised.
Humanity has been experiencing a new pandemic of the SARS Coronavirus-19 virus (SARS-CoV-2)
since December 2019, causing the disease known as COVID-19. As of March 23, 2020, there have
been 382,341 documented episodes of infection worldwide, of which 16,567 have died. An
important limitation in the treatment of the disease is the absence of drugs with known
antiviral activity against SARS-CoV-2. Recent data suggest that chloroquine has sufficient in
vitro activity against the SARS-CoV-2 virus by inhibiting virus entry into cells. It has
recently been described that hydroxychloroquine significantly reduces the percentage of
patients who have positive sputum in the SARS-CoV-2 virus within 6 days. However, the
clinical efficacy of the drug has not been described and it has significant side effects,
including more than 10% anorexia, headache, blurred vision, diarrhea or vomiting, and
myocardiotoxicity. The frequency of adverse effects of chloroquine in combination with the
well-known in vitro activity of chloroquine have led to the design of clinical trials around
the world to document the benefits of its use. The present study will evaluate the activity
of chloroquine phosphate in patients with SARS-CoV-2 virus infection.
Drug: UNIKINON (Chloroquine phosphate) 200mg tablets
Two and a half tablets (500mg) twice daily for seven days.
Inclusion Criteria:
- Age 18 or older
- Both genders
- For women of childbearing age, they should use or be willing to use a double
contraceptive method during the study. A urine pregnancy test to exclude pregnancy
will be performed prior to study initiation.
- Written consent after information provided by the patient or the legal representative
in the event that the patient cannot consent.
- Upper respiratory or lower respiratory tract infection, as in Annexes II and III
respectively.
- Positive respiratory secretion test for SARS-CoV-2 virus by molecular techniques or
positive blood IgM titers.
Exclusion Criteria:
- Under 18 years of age
- Denial of written consent
- Any patient case where it has been decided not to rejuvenate
- Serum AST values greater than 5 times the upper normal range
- QTc interval in rest electrocardiogram greater than 500msecs
- Pregnancy or lactation. Urgent pregnancy test to exclude pregnancy before inclusion in
the study
Divine Providence Hospital "Pammakaristos"
Athens, Greece
Athens General Hospital "Hippokrateio"
Athens, Greece
Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic
Athens, Greece
Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic
Athens, Greece
Corfu General Hospital Agia Irini
Corfu, Greece
University General Hospital of Ioannina
Ioánnina, Greece
General Hospital of Athens "Sismanoglio"
Maroúsi, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloníki, Greece