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

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ClinicalTrials.gov Identifier: NCT04344951
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Covid-19 Drug: UNIKINON (Chloroquine phosphate) 200mg tablets Phase 2

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.

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Study Type : Interventional
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open label, Phase II study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. 50% reduction in symptom score for patients with lower respiratory tract infection [ Time Frame: 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.

  2. Lack of progression for patients with upper respiratory tract infection [ Time Frame: 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 Outcome Measures :
  1. Comparison of the primary endpoint with respective patients not receiving the treatment [ Time Frame: 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.

  2. Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment. [ Time Frame: 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

  3. Frequency of AEs and SAEs [ Time Frame: Day 14 visit from study initiation ]
    Frequency of AEs and SAEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344951


Locations
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Greece
Divine Providence Hospital "Pammakaristos" Recruiting
Athens, Greece, 11144
Contact: Ioannis Baraboutis, MD    30 213 2042100    ioannisbaraboutis@gmail.com   
Athens General Hospital "Hippokrateio" Recruiting
Athens, Greece, 11527
Contact: Helen Sambatakou, MD    30 213 2088000    helensambatakou@msn.com   
Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic Recruiting
Athens, Greece, 11527
Contact: Nikolaos Koulouris, MD    30 210 7763702    koulnik@med.uoa.gr   
Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic Recruiting
Athens, Greece, 11527
Contact: Garyfallia Poulakou, MD    30 210 7763702    gpoulakou@gmail.com   
Corfu General Hospital Agia Irini Recruiting
Corfu, Greece, 491 00
Contact: Ilias Papanikolaou, MD    30 26610 33088    icpapanikolaou@hotmail.com   
Principal Investigator: Ilias Papanikolaou, MD         
University General Hospital of Ioannina Recruiting
Ioánnina, Greece, 455 00
Contact: Haralambos Milionis, MD    30 26510 99736    hmilioni@uoi.gr   
Principal Investigator: Haralambos Milionis, MD         
General Hospital of Athens "Sismanoglio" Recruiting
Maroúsi, Greece, 151 26
Contact: Malvina Lada, MD    30 213 2058 001    malvinalada@gmail.com   
University General Hospital of Thessaloniki AHEPA Recruiting
Thessaloníki, Greece, 54636
Contact: Symeon Metallidis, MD    30 2310 994656    metallidissimeon@yahoo.gr   
Principal Investigator: Symeon Metallidis, MD         
Sponsors and Collaborators
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
Investigators
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Principal Investigator: 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
Publications of Results:
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Responsible Party: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
ClinicalTrials.gov Identifier: NCT04344951    
Other Study ID Numbers: UNIKINON-01/HOPE
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.:
COVID-19
Pneumonia
Chloroquine phosphate
SARS-CoV-2
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics