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.
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.
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
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.
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai, China