Trial | NCT04344951  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    29
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.
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 Started
Apr 06
2020
Primary Completion
Nov 30
2020
Study Completion
Nov 30
2020
Last Update
Sep 23
2021

Drug UNIKINON (Chloroquine phosphate) 200mg tablets

Two and a half tablets (500mg) twice daily for seven days.

UNIKINON (Chloroquine phosphate) Experimental

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.

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
No Results Posted