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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pneumonia, Viral, Covid-19

Intervention / Treatment
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* Drug: UNIKINON (Chloroquine phosphate) 200mg tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open label, Phase II study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNIKINON (Chloroquine phosphate)<br>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. | Drug: UNIKINON (Chloroquine phosphate) 200mg tablets<br>* Two and a half tablets (500mg) twice daily for seven days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Frequency of AEs and SAEs | Frequency of AEs and SAEs | Day 14 visit from study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Pneumonia, Chloroquine phosphate, SARS-CoV-2