CHROLOQUINE PHOSPHATE AGAINST INFECTION BY THE NOVEL CORONAVIRUS

CHROLOQUINE PHOSPHATE AGAINST INFECTION BY THE NOVEL CORONAVIRUS SARS-CoV-2 (COVID-19): THE HOPE OPEN-LABEL, NON-RANDOMIZED CLINICAL TRIAL - HOPE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001345-38-GR

Enrollment

Registered

2020-03-31

Start date

2020-04-02

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Possible prevention of pneumonia from SARS-CoV-2 in patients staying home and improving symptoms of SARS-CoV-2 pneumonia in patients treated in hospital MedDRA version: 20.0 Level: LLT Classification code 10035738 Term: Pneumonia viral NOS System Organ Class: 100000004862

Interventions

Trade Name: UNIKINON Tablets 200mg/tab Product Name: UNIKINON Tablets 200mg/tab Pharmaceutical Form: Tablet INN or Proposed INN: CHLOROQUINE PHOSPHATE Other descriptive name: CHLOROQUINE PHOSPHATE Con

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Achieving one of two goals on day 8 visit from study initiation: • 50% reduction in symptom score for patients with lower respiratory tract infection • Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection Patients leaving the hospital alive before day 8 visit are considered to have reached the primary endpoint. Patients who die before the day 8 visit are considered to have failed at the primary endpoint.;Secondary Objective: • Comparison of the primary endpoint with respective patients not receiving the treatment • Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment • Frequency of AEs and SAEs;Primary end point(s): • Recording of co-administered drugs, vital signs, absolute blood cell count (if any), biochemical markers (if any), microbiological tests and antibiotics (if any) • Pneumonia symptoms ratings for patients with lower respiratory infection (Appendix V) • Recording of adverse reactions (AEs) or serious adverse reactions (SAEs);Timepoint(s) of evaluation of this end point: Days 1, 2-7, 8	—

Measure

Time frame

Main Objective: Achieving one of two goals on day 8 visit from study initiation: • 50% reduction in symptom score for patients with lower respiratory tract infection • Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection Patients leaving the hospital alive before day 8 visit are considered to have reached the primary endpoint. Patients who die before the day 8 visit are considered to have failed at the primary endpoint.;Secondary Objective: • Comparison of the primary endpoint with respective patients not receiving the treatment • Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment • Frequency of AEs and SAEs;Primary end point(s): • Recording of co-administered drugs, vital signs, absolute blood cell count (if any), biochemical markers (if any), microbiological tests and antibiotics (if any) • Pneumonia symptoms ratings for patients with lower respiratory infection (Appendix V) • Recording of adverse reactions (AEs) or serious adverse reactions (SAEs);Timepoint(s) of evaluation of this end point: Days 1, 2-7, 8

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Days 2-7, 8, 14;Secondary end point(s): • Severe respiratory failure (Appendix VI)	—

Countries

Greece

Contacts

Public ContactRegulatory Affairs department

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA

soumelas@uni-pharma.gr3021080725121374

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026