COVID-19 PneumoniaPhase 3NCT05713292
Pirfenidone in Adult Hospitalized Patients With COVID-19
A Phase 3 study testing Pirfenidone Oral Product in people with COVID-19 Pneumonia, run by Capital Medical University at 1 site in China.
Trial summary
This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Pirfenidone Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Mar 2023
- 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
- Subjects Age ≥ 18 Willing and able to provide written informed consent
- SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
- Time of illness onset ≥8 days
- Have findings consistent with interstitial lung disease found on CT scan
- Willing not use other investigational agents of anti-fibrosis
Who cannot join
- Pre-existing severe liver disease
- Pre-existing severe chronic kidney disease
- Pre-existing interstitial lung disease
- Pre-existing severe COPD or other structural lung disease
- Receiving invasive mechanical ventilation
- Currently Pregnant or Breast Feeding
Show all 9Show fewer
- Poor baseline health conditoin
- Disability to complete lung function test
- Receiving pirfenidone wthin half-year
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.
This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Pirfenidone Oral Product, Pirfenidone placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone Oral ProductDrug
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Pirfenidone placeboDrug
Pirfenidone placebo
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months Receives: Drug: Pirfenidone Oral Product |
| Placebo | Placebo comparator | Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months Receives: Drug: Pirfenidone placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
- Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up
- DLCO% pred at 1 month follow up
Measured: 1 month
Secondary outcomes (7)
distance walked in 6 Minutes (6MWD)
the difference between intervention group and placebo group
Measured: at the 1 month and 3 months follow-up vist
the EuroQol five-dimension five-level (EQ-5D-5L)
the difference between intervention group and placebo group
Measured: at the 1 month and 3 months follow-up vist
Medical Research Council (mMRC) dyspnoea scale
the difference of mMRC score between intervention group and placebo group
Measured: at the 1 month and 3 months follow-up vist
difference of forced vital capacity (FVC) between two groups
the difference of actual and predicted value between intervention group and placebo group
Measured: at the 1 month and 3 months follow-up vist
difference of total lung capacity (TLC) between two groups
the difference of actual and predicted value between intervention group and placebo group
Measured: at the 1 month and 3 months follow-up vist
difference of DLCO between two groups
the difference of actual and predicted value between intervention group and placebo group
Measured: at the 3 months follow-up vist
incidence of adverse event
the difference of adverse event frequency between intervention group and placebo group
Measured: within 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Dec 2022
- Primary completion4 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713292
- Sponsor's protocol ID
- CAP-China Pirfenidone
- Status last verified
- Jun 2024
- First submitted
- 1 Jan 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.
- ClinicalTrials.gov ID
- NCT05713292
- Acronym / sponsor ID
- CAP-China Pirfenidone
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Feb 2023 (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.
This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: Pirfenidone Oral ProductPirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months |
| Placebo | Placebo comparator | Drug: Pirfenidone placeboPirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects Age ≥ 18 Willing and able to provide written informed consent
- SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
- Time of illness onset ≥8 days
- Have findings consistent with interstitial lung disease found on CT scan
- Willing not use other investigational agents of anti-fibrosis
Key exclusion criteria (9 listed)
- Pre-existing severe liver disease
- Pre-existing severe chronic kidney disease
- Pre-existing interstitial lung disease
- Pre-existing severe COPD or other structural lung disease
- Receiving invasive mechanical ventilation
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 |
|---|---|---|
| Pirfenidone Oral ProductPirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months | Drug | Pirfenidone |
| Pirfenidone placeboPirfenidone placebo | Drug | Placebo |
Primary outcome
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
Time frame: 1 month
1. Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up 2. DLCO% pred at 1 month follow up
7 secondary outcomes
distance walked in 6 Minutes (6MWD)
Time frame: at the 1 month and 3 months follow-up vist
the EuroQol five-dimension five-level (EQ-5D-5L)
Time frame: at the 1 month and 3 months follow-up vist
Medical Research Council (mMRC) dyspnoea scale
Time frame: at the 1 month and 3 months follow-up vist
difference of forced vital capacity (FVC) between two groups
Time frame: at the 1 month and 3 months follow-up vist
difference of total lung capacity (TLC) between two groups
Time frame: at the 1 month and 3 months follow-up vist
difference of DLCO between two groups
Time frame: at the 3 months follow-up vist
incidence of adverse event
Time frame: within 2 months after enrollment
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 3 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone Oral Product in people with COVID-19 Pneumonia, run by Capital Medical University at 1 site 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 5 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection (time frame: 1 month). 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 3 Jul 2024.