Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04344951
Status:
TERMINATED
Last Update Posted:
2021-09-23
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C023676', 'term': 'chloroquine diphosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, open label, Phase II study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'No clinical efficacy against SARS-CoV-2 recorded', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '50% reduction in symptom score for patients with lower respiratory tract infection', 'timeFrame': 'Day 8 visit from study initiation', 'description': 'Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation.'}, {'measure': 'Lack of progression for patients with upper respiratory tract infection', 'timeFrame': 'Day 8 visit from study initiation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the primary endpoint with respective patients not receiving the treatment', 'timeFrame': 'Day 14 visit from study initiation', 'description': '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.'}, {'measure': 'Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment.', 'timeFrame': 'Day 14 visit from study initiation', 'description': 'It is defined as the presence of both of the following:\n\n* Respiratory quotient (pO2 / FiO2) less than 150\n* Need for treatment with CPAP or mechanical ventilation'}, {'measure': 'Frequency of AEs and SAEs', 'timeFrame': 'Day 14 visit from study initiation', 'description': 'Frequency of AEs and SAEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Pneumonia', 'Chloroquine phosphate', 'SARS-CoV-2'], 'conditions': ['Pneumonia, Viral', 'Covid-19']}, 'referencesModule': {'references': [{'pmid': '32125458', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32171740', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32205204', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Both genders\n* 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.\n* Written consent after information provided by the patient or the legal representative in the event that the patient cannot consent.\n* Upper respiratory or lower respiratory tract infection, as in Annexes II and III respectively.\n* Positive respiratory secretion test for SARS-CoV-2 virus by molecular techniques or positive blood IgM titers.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Denial of written consent\n* Any patient case where it has been decided not to rejuvenate\n* Serum AST values greater than 5 times the upper normal range\n* QTc interval in rest electrocardiogram greater than 500msecs\n* Pregnancy or lactation. Urgent pregnancy test to exclude pregnancy before inclusion in the study'}, 'identificationModule': {'nctId': 'NCT04344951', 'acronym': 'HOPE', 'briefTitle': 'Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.'}, 'officialTitle': 'Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UNIKINON-01/HOPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UNIKINON (Chloroquine phosphate)', 'description': '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.', 'interventionNames': ['Drug: UNIKINON (Chloroquine phosphate) 200mg tablets']}], 'interventions': [{'name': 'UNIKINON (Chloroquine phosphate) 200mg tablets', 'type': 'DRUG', 'description': 'Two and a half tablets (500mg) twice daily for seven days.', 'armGroupLabels': ['UNIKINON (Chloroquine phosphate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11144', 'city': 'Athens', 'country': 'Greece', 'facility': 'Divine Providence Hospital "Pammakaristos"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Athens General Hospital "Hippokrateio"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '491 00', 'city': 'Corfu', 'country': 'Greece', 'facility': 'Corfu General Hospital Agia Irini', 'geoPoint': {'lat': 39.62441, 'lon': 19.92016}}, {'zip': '455 00', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'University General Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': '151 26', 'city': 'Marousi', 'country': 'Greece', 'facility': 'General Hospital of Athens "Sismanoglio"', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'University General Hospital of Thessaloniki AHEPA', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Helen Sambatakou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athens General Hospital "Hippokrateio", 2nd department of Pathology'}, {'name': 'Nikolaos Koulouris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic'}, {'name': 'Garyfallia Poulakou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic'}, {'name': 'Malvina Lada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Athens "Sismanoglio", 2nd Department of Pathology'}, {'name': 'Ioannis Baraboutis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Divine Providence Hospital "Pammakaristos", Pathology Department'}, {'name': 'Symeon Metallidis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University General Hospital of Thessaloniki AHEPA, 1st University Pathology Clinic'}, {'name': 'Haralambos Milionis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University General Hospital of Ioannina, 1st University Pathology Clinic'}, {'name': 'Ilias Papanikolaou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corfu General Hospital Agia Irini, Pulmonary Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Athens General Hospital Hippokrateio', 'class': 'UNKNOWN'}, {'name': 'Sotiria Thoracic Diseases Hospital of Athens', 'class': 'OTHER'}, {'name': 'Sismanoglio General Hospital', 'class': 'OTHER'}, {'name': 'Divine Providence Hospital Pammakaristos', 'class': 'UNKNOWN'}, {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Ioannina', 'class': 'OTHER'}, {'name': 'Corfu General Hospital Agia Irini', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}