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

UNI Pharma

Status and phase: Terminated; Phase 2

Conditions: Pneumonia, Viral; Covid-19

Treatments: Drug: UNIKINON (Chloroquine phosphate) 200mg tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04344951

UNIKINON-01/HOPE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

UNIKINON (Chloroquine phosphate)

Experimental group

Description:

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.

Treatment:

Drug: UNIKINON (Chloroquine phosphate) 200mg tablets