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Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260594
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jieming QU, Ruijin Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
2019-nCoV Drug: Arbidol Other: basic treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Actual Study Start Date : February 8, 2020
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arbidol tablets + basic treatment Drug: Arbidol
Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
Other Name: The basic treatment used by the investigator was based on the condition of the patient

Other: basic treatment
basic treatment

Sham Comparator: basic treatment Other: basic treatment
basic treatment




Primary Outcome Measures :
  1. Virus negative conversion rate in the first week [ Time Frame: first week ]

Secondary Outcome Measures :
  1. Virus negative conversion rate [ Time Frame: 14-20 days ]
    virus negative conversion rate in second week, overall virus negative conversion rate

  2. Antipyretic rate [ Time Frame: 14-20 days ]
    defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h

  3. Symptom relief time [ Time Frame: 14-20 days ]
    time to relieve symptoms of fever, cough, dyspnea, myalgia, etc

  4. Finger oxygen improvement rate [ Time Frame: 14-20 days ]
    no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350

  5. Disease progression rate [ Time Frame: 14-20 days ]
    Mild, common type progression to severe or critical illness rate

  6. Mortality rate [ Time Frame: 14-20 days ]
  7. Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
  8. Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 18 to 65 years old (including 18 and 65 years);
  2. male and non-pregnant female;
  3. respiratory tract specimens or hematology samples detected positive results of SARS-CoV-2 by real-time transcriptase polymerase chain reaction (RT-PCR).
  4. 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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260594


Locations
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China, Shanghai
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Jieming QU
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Responsible Party: Jieming QU, professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04260594    
Other Study ID Numbers: Abdrcspc202001
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
COVID-19
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pneumonia, Viral