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No clinical efficacy against SARS-CoV-2 recorded
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| Name | Class |
|---|---|
| Athens General Hospital Hippokrateio | UNKNOWN |
| Sotiria Thoracic Diseases Hospital of Athens | OTHER |
| Sismanoglio General Hospital | OTHER |
| Divine Providence Hospital Pammakaristos |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNIKINON (Chloroquine phosphate) | Experimental | Once a patient is considered eligible for the study, they will receive oral chloroquine phosphate. The total duration of treatment will be 7 days. The dosage will be 500mg every 12 hours. It is clarified that any other treatment at the discretion of the therapist is permitted except for the administration of hydroxychloroquine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNIKINON (Chloroquine phosphate) 200mg tablets | Drug | Two and a half tablets (500mg) twice daily for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 8 visit from study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14 visit from study initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Sambatakou, MD | Athens General Hospital "Hippokrateio", 2nd department of Pathology | Principal Investigator |
| Nikolaos Koulouris, MD | Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic | Principal Investigator |
| Garyfallia Poulakou, MD | Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic | Principal Investigator |
| Malvina Lada, MD | General Hospital of Athens "Sismanoglio", 2nd Department of Pathology | Principal Investigator |
| Ioannis Baraboutis, MD | Divine Providence Hospital "Pammakaristos", Pathology Department | Principal Investigator |
| Symeon Metallidis, MD | University General Hospital of Thessaloniki AHEPA, 1st University Pathology Clinic | Principal Investigator |
| Haralambos Milionis, MD | University General Hospital of Ioannina, 1st University Pathology Clinic | Principal Investigator |
| Ilias Papanikolaou, MD | Corfu General Hospital Agia Irini, Pulmonary Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Divine Providence Hospital "Pammakaristos" | Athens | 11144 | Greece | |||
| Athens General Hospital "Hippokrateio" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32125458 | Result | Arabi YM, Murthy S, Webb S. COVID-19: a novel coronavirus and a novel challenge for critical care. Intensive Care Med. 2020 May;46(5):833-836. doi: 10.1007/s00134-020-05955-1. Epub 2020 Mar 3. No abstract available. | |
| 32171740 | Result | Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12. |
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| UNKNOWN |
| AHEPA University Hospital | OTHER |
| University Hospital, Ioannina | OTHER |
| Corfu General Hospital Agia Irini | UNKNOWN |
Prospective, open label, Phase II study
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| 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:
|
| Day 14 visit from study initiation |
| Frequency of AEs and SAEs | Frequency of AEs and SAEs | Day 14 visit from study initiation |
| Athens |
| 11527 |
| Greece |
| Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic | Athens | 11527 | Greece |
| Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic | Athens | 11527 | Greece |
| Corfu General Hospital Agia Irini | Corfu | 491 00 | Greece |
| University General Hospital of Ioannina | Ioannina | 455 00 | Greece |
| General Hospital of Athens "Sismanoglio" | Marousi | 151 26 | Greece |
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | 54636 | Greece |
| 32205204 | Result | Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20. |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C023676 | chloroquine diphosphate |
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