NCT04344951

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

April 6, 2020

Last Update Submit

September 16, 2021

Conditions

Pneumonia, ViralCovid-19

Keywords

COVID-19PneumoniaChloroquine phosphateSARS-CoV-2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Comparison of the primary endpoint with respective patients not receiving the treatment

    Day 14 visit from study initiation

  • Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment.

    Day 14 visit from study initiation

  • Frequency of AEs and SAEs

    Day 14 visit from study initiation

Study Arms (1)

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.

Drug: UNIKINON (Chloroquine phosphate) 200mg tablets

Interventions

UNIKINON (Chloroquine phosphate) 200mg tabletsDRUG

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

UNIKINON (Chloroquine phosphate)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Divine Providence Hospital "Pammakaristos"

Athens, 11144, Greece

Location

Athens General Hospital "Hippokrateio"

Athens, 11527, Greece

Location

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

Athens, 11527, Greece

Location

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

Athens, 11527, Greece

Location

Corfu General Hospital Agia Irini

Corfu, 491 00, Greece

Location

University General Hospital of Ioannina

Ioannina, 455 00, Greece

Location

General Hospital of Athens "Sismanoglio"

Marousi, 151 26, Greece

Location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

Related Publications (3)

  • 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.

    PMID: 32125458RESULT

  • 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.

    PMID: 32171740RESULT

  • 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.

    PMID: 32205204RESULT

MeSH Terms

Conditions

Pneumonia, ViralCOVID-19Pneumonia

Interventions

chloroquine diphosphate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Helen Sambatakou, MD

    Athens General Hospital "Hippokrateio", 2nd department of Pathology

    PRINCIPAL INVESTIGATOR

  • Nikolaos Koulouris, MD

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

    PRINCIPAL INVESTIGATOR

  • Garyfallia Poulakou, MD

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

    PRINCIPAL INVESTIGATOR

  • Malvina Lada, MD

    General Hospital of Athens "Sismanoglio", 2nd Department of Pathology

    PRINCIPAL INVESTIGATOR

  • Ioannis Baraboutis, MD

    Divine Providence Hospital "Pammakaristos", Pathology Department

    PRINCIPAL INVESTIGATOR

  • Symeon Metallidis, MD

    University General Hospital of Thessaloniki AHEPA, 1st University Pathology Clinic

    PRINCIPAL INVESTIGATOR

  • Haralambos Milionis, MD

    University General Hospital of Ioannina, 1st University Pathology Clinic

    PRINCIPAL INVESTIGATOR

  • Ilias Papanikolaou, MD

    Corfu General Hospital Agia Irini, Pulmonary Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective, open label, Phase II study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 14, 2020

Study Start

April 6, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

GR(8)