2019-nCoVPhase 4NCT04260594
Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus
A Phase 4 study testing Arbidol and basic treatment in people with 2019-nCoV, run by Jieming QU at 1 site in China.
Trial summary
In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 2019-nCoV
- What is being tested?
- Arbidol and basic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2020to 30 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 65 years old (including 18 and 65 years);
- male and non-pregnant female;
- respiratory tract specimens or hematology samples detected positive results of SARS-CoV-2 by real-time transcriptase polymerase chain reaction (RT-PCR).
- mild clinical status, defined as having mild clinical symptoms but no signs of pneumonia on imaging or moderate clinical status, defined as having fever, respiratory symptoms and pneumonia on imaging or severe clinical status, defined as having an oxygen saturation (SaO2) of 93% or less at ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at or below 400 mgHg, which can be rectified by oxygen inhalation through nasal catheter or face mask.
Who cannot join
- included a physician decision that involvement in the trial was not in the patient's best interest, known allergic reaction and / or severe allergic to arbidol, blood system dysfunction (platelet count <100×109/L, hemoglobin level <90g/L), severe liver dysfunction (total bilirubin level >2 times the normal upper limit, aspartic aminotransferase and alanine aminotransferase levels >3 times normal upper limit),severe renal dysfunction (serum creatinine >1.5 times the upper limit of normal value, calculated creatinine clearance rate <50 ml/min), treated with arbidol before admission, history of severe heart disease or clinically significant arrhythmia considered unsafe for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Randomized, Open, Multicenter Study on the Efficacy and Safety of Arbidol Hydrochloride Tablets in Treating Pneumonia in Patients Infected With Novel Coronavirus (2019-ncov).
In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.
Read the detailed description
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. The number of cases of infection with 2019-nCoV identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Mathematical models of the expansion phase of the epidemic suggested that sustained person-to-person transmission is occurring, and the R-zero is substantially above 1, the level required for a self-sustaining epidemic in human populations.
There is currently no specific treatment for 2019-ncov-infected pneumonia. Arbidol tablet is a non-nucleoside broad-spectrum antiviral drug with immune-enhancing effect. Abidor is pharmacodynamic in vitro against a variety of coronaviruses.This is a randomized, open, multicenter clinical study of pneumonic subjects diagnosed with 2019-ncov infection. The main objective was to compare the viral negative conversion rate in the first week after the subjects were randomized to arbidol plus basic treatment.
In this study, 380 eligible patients with pneumonia diagnosed with 2019-ncov infection were randomly assigned to one of two treatment groups at a 1:1 ratio.
patients will receive one of two treatment regimens: A .Abidor tablets + basic treatment B. basic treatment Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days Basic treatment :The basic treatment used by the investigator was based on the condition of the patient.
- Conditions
- 2019-nCoV
- Being tested
- Arbidol, basic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbidolDrug
Also called The basic treatment used by the investigator was based on the condition of the patient
Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
basic treatmentOther
basic treatment
| Study group | Role | What they receive |
|---|---|---|
| Arbidol tablets + basic treatment | Experimental | Not described Receives: Drug: Arbidol; Other: basic treatment |
| basic treatment | Sham comparator | Not described Receives: Other: basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus negative conversion rate in the first week
Measured: first week
Secondary outcomes (8)
Virus negative conversion rate
virus negative conversion rate in second week, overall virus negative conversion rate
Measured: 14-20 days
Antipyretic rate
defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h
Measured: 14-20 days
Symptom relief time
time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
Measured: 14-20 days
Finger oxygen improvement rate
no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350
Measured: 14-20 days
Disease progression rate
Mild, common type progression to severe or critical illness rate
Measured: 14-20 days
Mortality rate
Measured: 14-20 days
Incidence of severe adverse reactions
Measured: 14-20 days
Change curve of peripheral blood lymphocyte count
Measured: 14-20 days
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 start8 Feb 2020
- Primary completion12 Mar 2020
- Study completion30 Dec 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 2019-nCoVStudies 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jieming QU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260594
- Sponsor's protocol ID
- Abdrcspc202001
- Status last verified
- Sep 2021
- First submitted
- 6 Feb 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Zhang J, Jin Y, Tang Z, Hu K, Sun H, Shi M, Yang Q, Gu P, Guo H, Li Q, Zhang H, Li C, Yang M, Xiong N, Dong X, Xu J, Lin F, Wang T, Yang C, Huang B, Zhang J, Chen S, He Q, Zhou M, Qu J. A trial of arbidol hydrochloride in adults with COVID-19. Chin Med J (Engl). 2022 Jul 5;135(13):1531-1538. doi: 10.1097/CM9.0000000000002104.
PubMed 35830201
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Multicenter Study on the Efficacy and Safety of Arbidol Hydrochloride Tablets in Treating Pneumonia in Patients Infected With Novel Coronavirus (2019-ncov).
- ClinicalTrials.gov ID
- NCT04260594
- Acronym / sponsor ID
- Abdrcspc202001
- Conditions
- 2019-nCoV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Jieming QUUniversity, hospital or other
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 30 Dec 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.
In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.
Detailed description
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. The number of cases of infection with 2019-nCoV identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Mathematical models of the expansion phase of the epidemic suggested that sustained person-to-person transmission is occurring, and the R-zero is substantially above 1, the level required for a self-sustaining epidemic in human populations.
There is currently no specific treatment for 2019-ncov-infected pneumonia. Arbidol tablet is a non-nucleoside broad-spectrum antiviral drug with immune-enhancing effect. Abidor is pharmacodynamic in vitro against a variety of coronaviruses.This is a randomized, open, multicenter clinical study of pneumonic subjects diagnosed with 2019-ncov infection. The main objective was to compare the viral negative conversion rate in the first week after the subjects were randomized to arbidol plus basic treatment.
In this study, 380 eligible patients with pneumonia diagnosed with 2019-ncov infection were randomly assigned to one of two treatment groups at a 1:1 ratio.
patients will receive one of two treatment regimens: A .Abidor tablets + basic treatment B. basic treatment Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days Basic treatment :The basic treatment used by the investigator was based on the condition of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arbidol tablets + basic treatment | Experimental | Drug: Arbidol, Other: basic treatment |
| basic treatment | Sham comparator | Other: basic treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 to 65 years old (including 18 and 65 years);
- male and non-pregnant female;
- respiratory tract specimens or hematology samples detected positive results of SARS-CoV-2 by real-time transcriptase polymerase chain reaction (RT-PCR).
- mild clinical status, defined as having mild clinical symptoms but no signs of pneumonia on imaging or moderate clinical status, defined as having fever, respiratory symptoms and pneumonia on imaging or severe clinical status, defined as having an oxygen saturation (SaO2) of 93% or less at ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at or below 400 mgHg, which can be rectified by oxygen inhalation through nasal catheter or face mask.
Key exclusion criteria (1 listed)
- included a physician decision that involvement in the trial was not in the patient's best interest, known allergic reaction and / or severe allergic to arbidol, blood system dysfunction (platelet count <100×109/L, hemoglobin level <90g/L), severe liver dysfunction (total bilirubin level >2 times the normal upper limit, aspartic aminotransferase and alanine aminotransferase levels >3 times normal upper limit),severe renal dysfunction (serum creatinine >1.5 times the upper limit of normal value, calculated creatinine clearance rate <50 ml/min), treated with arbidol before admission, history of severe heart disease or clinically significant arrhythmia considered unsafe for the trial.
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 |
|---|---|---|
| ArbidolAlso: The basic treatment used by the investigator was based on the condition of the patientArbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days | Drug | Arbidol tablets + basic treatment |
| basic treatmentbasic treatment | Other | Arbidol tablets + basic treatment, basic treatment |
Primary outcome
Virus negative conversion rate in the first week
Time frame: first week
8 secondary outcomes
Virus negative conversion rate
Time frame: 14-20 days
Antipyretic rate
Time frame: 14-20 days
Symptom relief time
Time frame: 14-20 days
Finger oxygen improvement rate
Time frame: 14-20 days
Disease progression rate
Time frame: 14-20 days
Mortality rate
Time frame: 14-20 days
Incidence of severe adverse reactions
Time frame: 14-20 days
Change curve of peripheral blood lymphocyte count
Time frame: 14-20 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 8 Sep 2021.
- Derived from this study: PubMed 35830201Zhao J, Zhang J, Jin Y, Tang Z, Hu K, Sun H, Shi M, Yang Q, Gu P, Guo H, Li Q, Zhang H, Li C, Yang M, Xiong N, Dong X, Xu J, Lin F, Wang T, Yang C, Huang B, Zhang J, Chen S, He Q, Zhou M, Qu J. A trial of arbidol hydrochloride in adults with COVID-19. Chin Med J (Engl). 2022 Jul 5;135(13):1531-1538. doi: 10.1097/CM9.0000000000002104.
- Individual participant dataSharing planned: No
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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 4 study testing Arbidol and basic treatment in people with 2019-nCoV, run by Jieming QU 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 4 inclusion and 1 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 8 Sep 2021. 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 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?
Virus negative conversion rate in the first week (time frame: first week). 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 NCT04260594, 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 8 Sep 2021.