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A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia

An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255017
Enrollment
400
Registered
2020-02-05
Start date
2020-02-01
Completion date
2020-07-01
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2019-nCoV

Brief summary

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.

Interventions

Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.

DRUGOseltamivir

Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.

DRUGLopinavir/ritonavir

Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 2019-nCoV nucleic acid test was positive. 2. CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion criteria

1. Patients who meet any of the contraindications in the experimental drug labeling 2. Patients who do not want to participate in this clinical study

Design outcomes

Primary

MeasureTime frameDescription
Rate of disease remissiontwo weeksA: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2\> 93% or PaO2/FiO2\>300mmHg (1mmHg=0.133Kpa);
Time for lung recoverytwo weeksCompare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary

MeasureTime frame
Rate of lung imaging recoverytwo weeks
Rate of no fevertwo weeks
Rate of undetectable viral RNAtwo weeks
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recoverytwo weeks
Rate of respiratory symptom remissiontwo weeks

Countries

China

Contacts

Primary ContactQing Ning, Professor
qning@vip.sina.com+8613971521450
Backup ContactMeifang Han, Professor
mfhan@foxmail.com+8613986093605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026