Pneumonia, PneumocystisPhase 3NCT04261517
Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
A Phase 3 study testing Hydroxychloroquine in people with Pneumonia, Pneumocystis and Coronavirus, run by Shanghai Public Health Clinical Center at 2 sites in China.
Trial summary
The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis, Coronavirus, COVID-19
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 6 Feb 2020to 25 Feb 2020
- Phase
- Phase 3
- 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
- The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China;
- Participants aged over 18;
- Written the informed consent.
Who cannot join
- Hypersensitivity to chloroquine or hydroxychloroquine;
- Women during pregnancy;
- Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
- Participants with retinal disease, hearing loss;
- Participants with severe neurological and mental illness;
- Subjects were considered to be unable to complete the study, or not suitable for the study by researchers.
Show all 9Show fewer
- Exit criteria:
- Subjects asked to withdraw the study
- Subject will benefit if withdraw according to researchers' suggestions
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
About this study
The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Read the detailed description
There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
- Conditions
- Pneumonia, Pneumocystis, Coronavirus, COVID-19
- Being tested
- Hydroxychloroquine
- Keywords
- Pneumonia, COVID-19, hydroxychloroquine
- Medical subject headings
- Pneumonia, Pneumocystis, Coronavirus Infections, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine and conventional treatments | Experimental | After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments. Receives: Drug: Hydroxychloroquine |
| Conventional treatments | No intervention | After randomization, subjects take conventional treatments without hydroxychloroquine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Measured: 3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Measured: 5 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Measured: 7 days after randomization
The mortality rate of subjects at weeks 2
Measured: 14 days after randomization
Secondary outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 14 days after randomization
The critical illness rate of subjects at weeks 2
The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
Measured: 14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start6 Feb 2020
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, PneumocystisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261517
- Sponsor's protocol ID
- HC-COVID-19
- Status last verified
- Apr 2020
- First submitted
- 6 Feb 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.
PubMed 32391667
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04261517
- Acronym / sponsor ID
- HC-COVID-19
- Conditions
- Pneumonia, Pneumocystis, Coronavirus, COVID-19
- Keywords
- Pneumonia, COVID-19, hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 7 Feb 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 study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Detailed description
There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine and conventional treatments | Experimental | Drug: HydroxychloroquineAfter randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments. |
| Conventional treatments | No intervention | –After randomization, subjects take conventional treatments without hydroxychloroquine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China;
- Participants aged over 18;
- Written the informed consent.
Key exclusion criteria (9 listed)
- Hypersensitivity to chloroquine or hydroxychloroquine;
- Women during pregnancy;
- Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
- Participants with retinal disease, hearing loss;
- Participants with severe neurological and mental illness;
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 |
|---|---|---|
| HydroxychloroquineSubjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments | Drug | Hydroxychloroquine and conventional treatments |
Primary outcome
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time frame: 3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Time frame: 5 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time frame: 7 days after randomization
The mortality rate of subjects at weeks 2
Time frame: 14 days after randomization
2 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 14 days after randomization
The critical illness rate of subjects at weeks 2
Time frame: 14 days after randomization
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 13 Apr 2020.
- Derived from this study: PubMed 32391667Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.
- The results have been published on the Journal of Zhejiang University (Medical Sciences)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Hydroxychloroquine in people with Pneumonia, Pneumocystis and Coronavirus, run by Shanghai Public Health Clinical Center at 2 sites in China.
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 3 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 13 Apr 2020. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 (time frame: 3 days after randomization). The study lists 4 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 NCT04261517, which also lists 1 linked publication.
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 13 Apr 2020.