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Pneumonia, ViralPhase 2HOPENCT04344951

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

A Phase 2 study testing UNIKINON (Chloroquine phosphate) 200mg tablets in people with Pneumonia, Viral and Covid-19, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 8 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Pneumonia, Viral, Covid-19
What is being tested?
UNIKINON (Chloroquine phosphate) 200mg tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
8 sitesGreece
Study dates
6 Apr 2020to 30 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

8 sites in 1 country.

8 sites in 1 country

Greece8 sites

  • Divine Providence Hospital "Pammakaristos"

    Athens, 11144

  • Athens General Hospital "Hippokrateio"

    Athens, 11527

  • Athens General Hospital of Thoracic Diseases "SOTIRIA", 1st University Pulmonary Clinic

    Athens, 11527

  • Athens General Hospital of Thoracic Diseases "SOTIRIA", 3rd University Pathology Clinic

    Athens, 11527

  • Corfu General Hospital Agia Irini

    Corfu, 491 00

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • General Hospital of Athens "Sismanoglio"

    Marousi, 151 26

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

Other trials in Greece

About this study

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.

Read the detailed 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.

Being tested
UNIKINON (Chloroquine phosphate) 200mg tablets
Keywords
COVID-19, Pneumonia, Chloroquine phosphate, SARS-CoV-2
Medical subject headings
Pneumonia, Viral, COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UNIKINON (Chloroquine phosphate) 200mg tabletsDrug

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

Study groups in NCT04344951
Study groupRoleWhat they receive
UNIKINON (Chloroquine phosphate)ExperimentalOnce 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.
Receives: Drug: UNIKINON (Chloroquine phosphate) 200mg tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 8 visit from study initiation

  2. 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.

    Measured: Day 8 visit from study initiation

Secondary outcomes (3)

  1. 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.

    Measured: Day 14 visit from study initiation

  2. 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

    Measured: Day 14 visit from study initiation

  3. Frequency of AEs and SAEs

    Frequency of AEs and SAEs

    Measured: Day 14 visit from study initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start6 Apr 2020
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Why it stopped: No clinical efficacy against SARS-CoV-2 recorded

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, open label, Phase II study
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04344951
Sponsor's protocol ID
UNIKINON-01/HOPE
Acronym
HOPE
Status last verified
Sep 2021
First submitted
6 Apr 2020
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arabi YM, Murthy S, Webb S. COVID-19: a novel coronavirus and a novel challenge for critical care. Intensive Care Med. 2020 May;46(5):833-836. doi: 10.1007/s00134-020-05955-1. Epub 2020 Mar 3. No abstract available.

    PubMed 32125458

  • Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12.

    PubMed 32171740

  • Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

    PubMed 32205204

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UNIKINON (Chloroquine phosphate) 200mg tablets in people with Pneumonia, Viral and Covid-19, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 8 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: No clinical efficacy against SARS-CoV-2 recorded). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

50% reduction in symptom score for patients with lower respiratory tract infection (time frame: Day 8 visit from study initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04344951, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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