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

• Status: Terminated
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Collaborators: 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
• Treatments: Chloroquine; Chloroquine diphosphate

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