NCT04260594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 8, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

February 6, 2020

Last Update Submit

September 6, 2021

Conditions

2019-nCoV

Outcome Measures

Primary Outcomes (1)

  • Virus negative conversion rate in the first week

    first week

Secondary Outcomes (8)

  • Virus negative conversion rate

    14-20 days

  • Antipyretic rate

    14-20 days

  • Symptom relief time

    14-20 days

  • Finger oxygen improvement rate

    14-20 days

  • Disease progression rate

    14-20 days

  • +3 more secondary outcomes

Study Arms (2)

Arbidol tablets + basic treatment

EXPERIMENTAL
Drug: ArbidolOther: basic treatment

basic treatment

SHAM COMPARATOR
Other: basic treatment

Interventions

ArbidolDRUG

Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days

Also known as: The basic treatment used by the investigator was based on the condition of the patient
Arbidol tablets + basic treatment
basic treatmentOTHER

basic treatment

Arbidol tablets + basic treatmentbasic treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • 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;135(13):1531-8. doi: 10.1097/CM9.0000000000002104. Online ahead of print.

    PMID: 35830201DERIVED

MeSH Terms

Interventions

umifenovir

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 7, 2020

Study Start

February 8, 2020

Primary Completion

March 12, 2020

Study Completion

December 30, 2020

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)