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

Covid-19 Clinical Trial

— HOPE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04344951
• Other study ID #: UNIKINON-01/HOPE
• Status: Terminated
• Phase: Phase 2
• Start date: April 6, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2021
• Source: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Pneumonia
• Pneumonia, Viral

Intervention

Drug:
• UNIKINON (Chloroquine phosphate) 200mg tablets
Two and a half tablets (500mg) twice daily for seven days.

Locations

Country	Name	City	State
Greece	Athens General Hospital "Hippokrateio"	Athens
Greece	Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic	Athens
Greece	Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic	Athens
Greece	Divine Providence Hospital "Pammakaristos"	Athens
Greece	Corfu General Hospital Agia Irini	Corfu
Greece	University General Hospital of Ioannina	Ioánnina
Greece	General Hospital of Athens "Sismanoglio"	Maroúsi
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloníki

Sponsors (8)

Lead Sponsor	Collaborator
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	AHEPA University Hospital, Athens General Hospital Hippokrateio, Athens General Hospital of Thoracic Diseases SOTIRIA, Corfu General Hospital Agia Irini, Divine Providence Hospital Pammakaristos, General Hospital of Athens Sismanoglio, University General Hospital of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. Erratum in: Intensive Care Med. 2020 Mar 18;:. — View 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. — View Citation

Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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: Respiratory quotient (pO2 / FiO2) less than 150; Need for treatment with CPAP or mechanical ventilation	Day 14 visit from study initiation
Secondary	Frequency of AEs and SAEs	Frequency of AEs and SAEs	Day 14 visit from study initiation