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

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.

Study Overview

• Status: Completed
• Conditions: 2019-nCoV
• Intervention / Treatment: Drug: Arbidol; Other: basic treatment

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Medical School of Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arbidol tablets + basic treatment	Drug: Arbidol; Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Virus negative conversion rate in the first week	first week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virus negative conversion rate	virus negative conversion rate in second week, overall virus negative conversion rate	14-20 days
Antipyretic rate	defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h	14-20 days
Symptom relief time	time to relieve symptoms of fever, cough, dyspnea, myalgia, etc	14-20 days
Finger oxygen improvement rate	no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350	14-20 days
Disease progression rate	Mild, common type progression to severe or critical illness rate	14-20 days
Mortality rate		14-20 days
Incidence of severe adverse reactions		14-20 days
Change curve of peripheral blood lymphocyte count		14-20 days

Collaborators and Investigators

• Sponsor: Jieming QU

Publications and helpful links

General 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 14. doi: 10.1097/CM9.0000000000002104. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2020
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: Abdrcspc202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No