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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-06

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19

NCT04575558

Sars-CoV2

WITHDRAWN PHASE2

The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial

NCT04364815

COVID-19

WITHDRAWN PHASE3

Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection

NCT04342650

COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia +1 more

COMPLETED PHASE2

Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2

NCT04323527

SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia

COMPLETED PHASE2

Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients

NCT04443270

COVID-19

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia, Viral Covid-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, open label, Phase II study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UNIKINON (Chloroquine phosphate)

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.

Group Type EXPERIMENTAL

UNIKINON (Chloroquine phosphate) 200mg tablets

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UNIKINON (Chloroquine phosphate) 200mg tablets

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No