Covid-19, Pneumonia, Viral
Conditions
Keywords
COVID-19, Pneumonia, Chloroquine phosphate, SARS-CoV-2
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.
Interventions
DRUGUNIKINON (Chloroquine phosphate) 200mg tablets
Two and a half tablets (500mg) twice daily for seven days.
Sponsors
Athens General Hospital Hippokrateio
Sotiria Thoracic Diseases Hospital of Athens
Sismanoglio General Hospital
Divine Providence Hospital Pammakaristos
AHEPA University Hospital
University Hospital, Ioannina
Corfu General Hospital Agia Irini
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, open label, Phase II study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction in symptom score for patients with lower respiratory tract infection | Day 8 visit from study initiation | Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation. |
| Lack of progression for patients with upper respiratory tract infection | Day 8 visit from study initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the primary endpoint with respective patients not receiving the treatment | Day 14 visit from study initiation | 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. |
| Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment. | Day 14 visit from study initiation | 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 |
| Frequency of AEs and SAEs | Day 14 visit from study initiation | Frequency of AEs and SAEs |
Countries
Greece
Outcome results
None listed