Pneumonia, PneumocystisPhase 3DC-COVID-19NCT04252274
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
A Phase 3 study testing Darunavir and Cobicistat 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 darunavir and cobistastat in the treatment of COVID-19 pneumonia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Pneumocystis, Coronavirus
- What is being tested?
- Darunavir and Cobicistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jan 2020to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, 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.
- Written the informed consent
Who cannot join
- Hypersensitivity to darunavir, cobicistat, or any excipients
- Patients with severe liver injury (Child-Pugh Class C)
- Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.
- Subjects were considered to be unable to complete the study, or not suitable for the study by researchers
- 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, 2 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Hongzhou Lu, 008602137990333 ext. 3222
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
Hongzhou Lu, PI, +86-021-37990333 ext. 3222, luhongzhou@fudan.edu.cn
About this study
The study aims to evaluate the efficacy and safety of darunavir and cobistastat 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 darunavir and cobistastat in the treatment of COVID-19 pneumonia.
- Conditions
- Pneumonia, Pneumocystis, Coronavirus
- Being tested
- Darunavir and Cobicistat
- Keywords
- Pneumonia, COVID-19, Darunavir, Cobicistat
- Medical subject headings
- Pneumonia, Pneumocystis, Coronavirus Infections, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir and CobicistatDrug
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
| Study group | Role | What they receive |
|---|---|---|
| Darunavir, Cobicistat and conventional treatments | Experimental | After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments. Receives: Drug: Darunavir and Cobicistat |
| Conventional treatments | No intervention | After randomization, subjects take conventional treatments without darunavir and cobicistat. |
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 7
Measured: 7 days after randomization
Secondary outcomes (5)
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
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
The mortality rate of subjects at weeks 2
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 posted5 Feb 2020
- Study start30 Jan 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 (estimated)
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
- NCT04252274
- Sponsor's protocol ID
- DC-COVID-19
- Acronym
- DC-COVID-19
- Status last verified
- Apr 2020
- First submitted
- 29 Jan 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 2020 Jun 21;7(7):ofaa241. doi: 10.1093/ofid/ofaa241. eCollection 2020 Jul.
PubMed 32671131
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 Darunavir and Cobicistat for Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04252274
- Acronym / sponsor ID
- DC-COVID-19 / DC-COVID-19
- Conditions
- Pneumonia, Pneumocystis, Coronavirus
- Keywords
- Pneumonia, COVID-19, Darunavir, Cobicistat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 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 darunavir and cobistastat 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 darunavir and cobistastat 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 |
|---|---|---|
| Darunavir, Cobicistat and conventional treatments | Experimental | Drug: Darunavir and CobicistatAfter randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments. |
| Conventional treatments | No intervention | –After randomization, subjects take conventional treatments without darunavir and cobicistat. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 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.
- Written the informed consent
Key exclusion criteria (7 listed)
- Hypersensitivity to darunavir, cobicistat, or any excipients
- Patients with severe liver injury (Child-Pugh Class C)
- Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.
- Subjects were considered to be unable to complete the study, or not suitable for the study by researchers
- Subjects asked to withdraw the study
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 |
|---|---|---|
| Darunavir and CobicistatSubjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments | Drug | Darunavir, Cobicistat and conventional treatments |
Primary outcome
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time frame: 7 days after randomization
5 secondary outcomes
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
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
The mortality rate of subjects at weeks 2
Time frame: 14 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 32671131Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 2020 Jun 21;7(7):ofaa241. doi: 10.1093/ofid/ofaa241. eCollection 2020 Jul.
Related trials for Pneumonia, Pneumocystis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingObservational study
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Enrolling by invitation
Patient-Centered Practical Vaccine Talk For Busy Clinicians
Influenza, 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.
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 Darunavir and Cobicistat 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 2 inclusion and 7 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, Ph.D (+86-021-37990333 ext. 3222, luhongzhou@fudan.edu.cn), or a site near the patient. 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 7 (time frame: 7 days after randomization). 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 NCT04252274, 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.