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

Sponsor

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04344951

Collaborator

Athens General Hospital Hippokrateio (Other), Athens General Hospital of Thoracic Diseases SOTIRIA (Other), General Hospital of Athens Sismanoglio (Other), Divine Providence Hospital Pammakaristos (Other), AHEPA University Hospital (Other), University General Hospital of Ioannina (Other), Corfu General Hospital Agia Irini (Other)

Enrollment

Locations

Arm

7.8

Actual Duration (Months)

3.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, open label, Phase II studyProspective, 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 :

Apr 6, 2020

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Divine Providence Hospital "Pammakaristos"	Athens	Greece	11144
2	Athens General Hospital "Hippokrateio"	Athens	Greece	11527
3	Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic	Athens	Greece	11527
4	Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic	Athens	Greece	11527
5	Corfu General Hospital Agia Irini	Corfu	Greece	491 00
6	University General Hospital of Ioannina	Ioánnina	Greece	455 00
7	General Hospital of Athens "Sismanoglio"	Maroúsi	Greece	151 26
8	University General Hospital of Thessaloniki AHEPA	Thessaloníki	Greece	54636

Investigators

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