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

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ClinicalTrials.gov Identifier: NCT04260594
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
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)
Estimated Enrollment : 380 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).
Estimated Study Start Date : February 7, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated 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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign the informed consent form;
  2. Age ≥18 years, regardless of gender;
  3. Subjects with pneumonia diagnosed as 2019-nCoV infection; A) Detection of 2019-nCoV nucleic acid positive by RT-PCR in respiratory tract or blood samples.

    B) The virus gene sequence of respiratory tract or blood samples is highly homologous to the known 2019-nCoV.

  4. According to the standard of "pneumonia diagnosis and treatment Program of New Coronavirus infection (trial Fifth Edition)" issued by National Health Commission of the People's Republic of China, clinical classification: mild, ordinary subjects; A) Mild type, the clinical symptoms were mild and no pneumonia was found in imaging.

B) Common type, With fever, respiratory tract and other symptoms, the manifestations of pneumonia can be seen on imaging.

Exclusion Criteria:

  1. Critical type:

    If one of the following conditions is met:

    A) Respiratory failure occurs and mechanical ventilation is needed; B) Shock occurred; C) Patients with other organ failure need ICU monitoring treatment.

  2. Severe type:

    If one of the following conditions is met:

    A) Respiratory distress, RR ≥ 30 beats / min; B) In resting state, finger oxygen saturation (SaO2) ≤ 93%; C) Partial pressure of arterial oxygen (PaO2) / concentration of oxygen inhaled (FiO2)≤300mmHg)

  3. Those who have a history of allergy to this class of drugs and / or severe allergic constitution;
  4. The results of laboratory tests are abnormal:

    A) Hematological dysfunction is defined as:

    i) Platelet (PLT) count: <100 × 109 / L; ii) hemoglobin (Hb) level <90g/L.

    B) abnormal liver function is defined as:

    i) level of total bilirubin(TBil) : >2 times Upper Limits of Normal(ULN); ii) the levels of aspartate aminotransferase (AST) and Alanine transaminase (ALT):>3 times of ULN.

    C) definition of renal dysfunction:

    Serum creatinine>1.5 times of ULN, or calculated creatinine clearance<50ml / min;

    D) definition of abnormal blood coagulation:

    International normalized ratio(INR) >1.5 times of ULN, and the prothrombin time ((PT)) or activated partial thromboplastin time (aPTT) is 1.5 times of ULN, unless the subject is receiving anticoagulant therapy.

  5. Abidor was used before inclusion(Tablets, capsules, granules).
  6. Women who are nursing or pregnant.
  7. Serum or urine pregnancy tests were positive for women of child-bearing age.
  8. Immunodeficient patient(Patients with malignant tumors, Organ or bone marrow transplant, HIV patient, those who took immunosuppressive drugs within 3 months before the screening test ).
  9. With the following history of present illness:

    1. Neurological and neurodevelopmental disorders, These include diseases of the brain, spinal cord, peripheral nerves and muscles(Such as cerebral palsy, epilepsy, stroke, mental retardation, moderate to severe developmental delay, muscular malnutrition or spinal cord injury ).
    2. circulation system disease( congenital heart disease, Congestive heart failure or coronary artery disease).
    3. Severe heart disease or a history of clinically significant arrhythmias that the researchers believe will affect participants' safety (According to the ECG or medical history).
  10. Other patients considered ineligible for this study were considered ineligible by the investigators

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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: February 7, 2020
Last Verified: February 2020

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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
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections