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

NCT ID: NCT04255017

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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2019-nCoV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Symptomatic supportive treatment

Symptomatic supportive treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Abidol hydrochloride was added on the basis of group I.

Abidol hydrochloride 0.2g once,3 times a day,2 weeks

Group Type EXPERIMENTAL

Abidol hydrochloride

Intervention Type DRUG

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

Oseltamivir was added on the basis of group I.

Oseltamivir 75mg once,twice a day,2 weeks

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

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

Lopinavir/ritonavir was added on the basis of group I.

Lopinavir/ritonavir 500mg once,twice a day,2 weeks

Group Type EXPERIMENTAL

Lopinavir/ritonavir

Intervention Type DRUG

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

Interventions

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Abidol hydrochloride

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

Intervention Type DRUG

Oseltamivir

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

Intervention Type DRUG

Lopinavir/ritonavir

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Ning

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department and Institute of Infectious Disease

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qing Ning, Professor

Role: CONTACT

+8613971521450

Meifang Han, Professor

Role: CONTACT

+8613986093605

Facility Contacts

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Qin Ning, professor

Role: primary

Meifang Han, professor

Role: backup

Other Identifiers

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TJ20200128

Identifier Type: -

Identifier Source: org_study_id

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