NCT04331600

Brief Summary

The aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death, in ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

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

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

February 11, 2021

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

March 30, 2020

Last Update Submit

February 10, 2021

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • COVID-19-related hospitalization or all-cause death

    Composite endpoint of COVID-19-related hospitalization or all-cause death

    15 days

Secondary Outcomes (3)

  • Decrease in COVID-19 symptoms

    15 days and 42 days

  • Development of pneumonia

    42 days

  • Development of coronavirus infection-related complications

    42 days

Study Arms (2)

CHLOROQUINE

EXPERIMENTAL

Standard of care + chloroquine phosphate + telemedical approach.

Drug: Chloroquine phosphateOther: Telemedicine

CONTROL GROUP

OTHER

Standard of care + telemedical approach.

Other: Telemedicine

Interventions

Chloroquine phosphateDRUG

Oral chloroquine phosphate for 14 days

CHLOROQUINE
TelemedicineOTHER

Telemedical supervision for 42 days

CHLOROQUINECONTROL GROUP

Eligibility Criteria

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

You may qualify if:

  • age \>=60 years OR age 18-59 years with one of the following conditions:
  • chronic lung disease
  • chronic cardiovascular disease
  • diabetes
  • malignancy diagnosed within 5 years prior to enrollment
  • history of chronic kidney disease
  • atrial fibrillation
  • past haemorrhagic stroke, ischemic stroke or transient CNS ischemia
  • obesity defined as BMI ≥ 30 kg / m2
  • year risk of fatal cardiovascular disease
  • SARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)
  • Hospitalization not required based on clinical judgement
  • Ability to participate in telemedical care

You may not qualify if:

  • Lack of written informed consent
  • Possible failure to comply with the protocol
  • Chloroquine, hydroxychloroquine therapy within 30 days prior to enrollment
  • Antiviral therapy within 14 days prior to enrollment
  • Contraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia)
  • Hypersensitivity to chloroquine or drug excipients
  • HIV infection
  • Other relevant circumstances/conditions based on clinical judgement
  • Concurrent participation in another interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniwersytecki Szpital Kliniczny

Wroclaw, Ul. Borowska 213, 50-556, Poland

Location

Wielospecjalistyczny Szpital Miejski

Poznan, Ul. Szwajcarska 3, 61-285, Poland

Location

MeSH Terms

Conditions

COVID-19

Interventions

chloroquine diphosphateTelemedicine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

April 16, 2020

Primary Completion

December 17, 2020

Study Completion

December 17, 2020

Last Updated

February 11, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)