2019-nCoVPhase 4NCT04255017
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
A Phase 4 study testing Abidol hydrochloride, Oseltamivir and Lopinavir/ritonavir in people with 2019-nCoV, run by Tongji Hospital at 1 site in China.
Trial summary
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019-nCoV
- What is being tested?
- Abidol hydrochloride, Oseltamivir and Lopinavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Jul 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
- 2019-nCoV nucleic acid test was positive.
- CT of the lung conformed to the manifestation of viral pneumonia.
Who cannot join
- Patients who meet any of the contraindications in the experimental drug labeling
- Patients who do not want to participate in this clinical study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
Meifang Han, professor, mfhan@foxmail.com
About this study
Official title: An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
- Conditions
- 2019-nCoV
- Being tested
- Abidol hydrochloride, Oseltamivir, Lopinavir/ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abidol hydrochlorideDrug
Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
OseltamivirDrug
Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
Lopinavir/ritonavirDrug
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic supportive treatment | No intervention | Symptomatic supportive treatment |
| Abidol hydrochloride was added on the basis of group I. | Experimental | Abidol hydrochloride 0.2g once,3 times a day,2 weeks Receives: Drug: Abidol hydrochloride |
| Oseltamivir was added on the basis of group I. | Experimental | Oseltamivir 75mg once,twice a day,2 weeks Receives: Drug: Oseltamivir |
| Lopinavir/ritonavir was added on the basis of group I. | Experimental | Lopinavir/ritonavir 500mg once,twice a day,2 weeks Receives: Drug: Lopinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease remission
A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Measured: two weeks
Time for lung recovery
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measured: two weeks
Secondary outcomes (5)
Rate of no fever
Measured: two weeks
Rate of respiratory symptom remission
Measured: two weeks
Rate of lung imaging recovery
Measured: two weeks
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery
Measured: two weeks
Rate of undetectable viral RNA
Measured: two weeks
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 start1 Feb 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoVStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255017
- Sponsor's protocol ID
- TJ20200128
- Status last verified
- Mar 2020
- First submitted
- 2 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.
- ClinicalTrials.gov ID
- NCT04255017
- Acronym / sponsor ID
- TJ20200128
- Conditions
- 2019-nCoV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 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.
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Symptomatic supportive treatment | No intervention | –Symptomatic supportive treatment |
| Abidol hydrochloride was added on the basis of group I. | Experimental | Drug: Abidol hydrochlorideAbidol hydrochloride 0.2g once,3 times a day,2 weeks |
| Oseltamivir was added on the basis of group I. | Experimental | Drug: OseltamivirOseltamivir 75mg once,twice a day,2 weeks |
| Lopinavir/ritonavir was added on the basis of group I. | Experimental | Drug: Lopinavir/ritonavirLopinavir/ritonavir 500mg once,twice a day,2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 2019-nCoV nucleic acid test was positive.
- CT of the lung conformed to the manifestation of viral pneumonia.
Key exclusion criteria (2 listed)
- Patients who meet any of the contraindications in the experimental drug labeling
- Patients who do not want to participate in this clinical 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 |
|---|---|---|
| Abidol hydrochlorideAbidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I. | Drug | Abidol hydrochloride was added on the basis of group I. |
| OseltamivirOseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I. | Drug | Oseltamivir was added on the basis of group I. |
| Lopinavir/ritonavirLopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I. | Drug | Lopinavir/ritonavir was added on the basis of group I. |
Primary outcome
Rate of disease remission
Time frame: two weeks
A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Time for lung recovery
Time frame: two weeks
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
5 secondary outcomes
Rate of no fever
Time frame: two weeks
Rate of respiratory symptom remission
Time frame: two weeks
Rate of lung imaging recovery
Time frame: two weeks
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery
Time frame: two weeks
Rate of undetectable viral RNA
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for 2019-nCoV
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Physiological Finding in Management of COVID 19 Patients
COVID-19 (Coronavirus Disease 2019)
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
RecruitingPhase 1
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
Healthy Participants
Active, not recruitingPhase 4
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abidol hydrochloride, Oseltamivir and Lopinavir/ritonavir in people with 2019-nCoV, run by Tongji Hospital 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 2 inclusion and 2 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 17 Mar 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disease remission (time frame: two weeks). The study lists 2 primary outcomes in all. 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 17 Mar 2020.