Official Title
Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Brief Summary

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.

Detailed Description

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.

Recruiting
Pneumonia, Viral
COVID-19

Drug: UNIKINON (Chloroquine phosphate) 200mg tablets
Two and a half tablets (500mg) twice daily for seven days.
UNIKINON (Chloroquine phosphate)

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 90 Years
Countries
Greece

Helen Sambatakou, MD
Principal Investigator
Athens General Hospital "Hippokrateio", 2nd department of Pathology

~

Nikolaos Koulouris, MD
Principal Investigator
Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic

~

Garyfallia Poulakou, MD
Principal Investigator
Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic

~

Malvina Lada, MD
Principal Investigator
General Hospital of Athens "Sismanoglio", 2nd Department of Pathology

~

Ioannis Baraboutis, MD
Principal Investigator
Divine Providence Hospital "Pammakaristos", Pathology Department

~

Symeon Metallidis, MD
Principal Investigator
University General Hospital of Thessaloniki AHEPA, 1st University Pathology Clinic

~

Haralambos Milionis, MD
Principal Investigator
University General Hospital of Ioannina, 1st University Pathology Clinic

~

Ilias Papanikolaou, MD
Principal Investigator
Corfu General Hospital Agia Irini, Pulmonary Clinic

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Athens General Hospital Hippokrateio
Athens General Hospital of Thoracic Diseases SOTIRIA
General Hospital of Athens Sismanoglio
Divine Providence Hospital Pammakaristos
AHEPA University Hospital
University General Hospital of Ioannina
Corfu General Hospital Agia Irini
NCT Number
Keywords
Covid-19
Pneumonia
Chloroquine phosphate
SARS-CoV-2
MeSH Terms
Pneumonia, Viral
Pneumonia
Chloroquine
Chloroquine diphosphate