Status:
TERMINATED
Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Lead Sponsor:
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Collaborating Sponsors:
Athens General Hospital Hippokrateio
Sotiria Thoracic Diseases Hospital of Athens
Conditions:
Pneumonia, Viral
Covid-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 patie...
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04344951
Start Date
April 6 2020
End Date
November 30 2020
Last Update
September 23 2021
Active Locations (8)
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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