COVID-19Phase 4NCT04331600
Chloroquine as Antiviral Treatment in Coronavirus Infection 2020
A Phase 4 study testing Chloroquine phosphate and Telemedicine in people with COVID-19, run by Wroclaw Medical University at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Chloroquine phosphate and Telemedicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesPoland
- Study dates
- 16 Apr 2020to 17 Dec 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- atrial fibrillation
- past haemorrhagic stroke, ischemic stroke or transient CNS ischemia
- obesity defined as BMI ≥ 30 kg / m2
- 10-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
Who cannot join
- 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
Show all 9Show fewer
- HIV infection
- Other relevant circumstances/conditions based on clinical judgement
- Concurrent participation in another interventional clinical trial
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Wielospecjalistyczny Szpital Miejski
Poznan, Ul. Szwajcarska 3, 61-285
Uniwersytecki Szpital Kliniczny
Wroclaw, Ul. Borowska 213, 50-556
About this study
Official title: Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Efficacy and Safety of Chloroquine Phosphate in Combination With Telemedicine Care in the Risk Reduction of COVID-19 Related Hospitalization or Death, in Ambulatory Patients With COVID-19 Being at Risk of Serious Complications
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).
Read the detailed description
Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prophylaxis of COVID-19; however there are currently being initiated studies in Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds inhibiting host inflammatory reactions, especially (and potentially selectively) in respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.
- Conditions
- COVID-19
- Being tested
- Chloroquine phosphate, Telemedicine
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine phosphateDrug
Oral chloroquine phosphate for 14 days
TelemedicineOther
Telemedical supervision for 42 days
| Study group | Role | What they receive |
|---|---|---|
| CHLOROQUINE | Experimental | Standard of care + chloroquine phosphate + telemedical approach. Receives: Drug: Chloroquine phosphate; Other: Telemedicine |
| CONTROL GROUP | Other | Standard of care + telemedical approach. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19-related hospitalization or all-cause death
Composite endpoint of COVID-19-related hospitalization or all-cause death
Measured: 15 days
Secondary outcomes (3)
Decrease in COVID-19 symptoms
Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).
Measured: 15 days and 42 days
Development of pneumonia
Based on X-ray, microbiology and laboratory results
Measured: 42 days
Development of coronavirus infection-related complications
Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start16 Apr 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331600
- Sponsor's protocol ID
- WROCLAW CORONA STUDY 2020
- Status last verified
- May 2020
- First submitted
- 30 Mar 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Efficacy and Safety of Chloroquine Phosphate in Combination With Telemedicine Care in the Risk Reduction of COVID-19 Related Hospitalization or Death, in Ambulatory Patients With COVID-19 Being at Risk of Serious Complications
- ClinicalTrials.gov ID
- NCT04331600
- Acronym / sponsor ID
- WROCLAW CORONA STUDY 2020
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prophylaxis of COVID-19; however there are currently being initiated studies in Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds inhibiting host inflammatory reactions, especially (and potentially selectively) in respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHLOROQUINE | Experimental | Drug: Chloroquine phosphate, Other: TelemedicineStandard of care + chloroquine phosphate + telemedical approach. |
| CONTROL GROUP | Other | Other: TelemedicineStandard of care + telemedical approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age >=60 years OR age 18-59 years with one of the following conditions:
- SARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)
- Hospitalization not required based on clinical judgement
- Ability to participate in telemedical care
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroquine phosphateOral chloroquine phosphate for 14 days | Drug | CHLOROQUINE |
| TelemedicineTelemedical supervision for 42 days | Other | CHLOROQUINE, CONTROL GROUP |
Primary outcome
COVID-19-related hospitalization or all-cause death
Time frame: 15 days
Composite endpoint of COVID-19-related hospitalization or all-cause death
3 secondary outcomes
Decrease in COVID-19 symptoms
Time frame: 15 days and 42 days
Development of pneumonia
Time frame: 42 days
Development of coronavirus infection-related complications
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine phosphate and Telemedicine in people with COVID-19, run by Wroclaw Medical University at 2 sites in Poland.
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 13 inclusion and 9 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: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID-19-related hospitalization or all-cause death (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2021.