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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
29
Two and a half tablets (500mg) twice daily for seven days.
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
50% reduction in symptom score for patients with lower respiratory tract infection
Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation.
Time frame: Day 8 visit from study initiation
Lack of progression for patients with upper respiratory tract infection
Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection on day 8 visit from study initiation.
Time frame: Day 8 visit from study initiation
Comparison of the primary endpoint with respective patients not receiving the treatment
Lower respiratory tract infection rating takes place. The symptoms checked are: Cough, Chest pain, Dyspnea, expectoration. For each symptom score is given from 0 to 3 depending on the intensity and they are summed.
Time frame: Day 14 visit from study initiation
Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment.
It is defined as the presence of both of the following: * Respiratory quotient (pO2 / FiO2) less than 150 * Need for treatment with CPAP or mechanical ventilation
Time frame: Day 14 visit from study initiation
Frequency of AEs and SAEs
Frequency of AEs and SAEs
Time frame: Day 14 visit from study initiation
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Athens, Greece
Corfu General Hospital Agia Irini
Corfu, Greece
University General Hospital of Ioannina
Ioannina, Greece
General Hospital of Athens "Sismanoglio"
Marousi, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, Greece