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.

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.

Study Overview

• Status: Unknown
• Conditions: 2019-nCoV
• Intervention / Treatment: Drug: Abidol hydrochloride; Drug: Oseltamivir; Drug: Lopinavir/ritonavir

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department and Institute of Infectious Disease

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Symptomatic supportive treatment
Experimental: Abidol hydrochloride was added on the basis of group I.; Abidol hydrochloride 0.2g once,3 times a day,2 weeks	Drug: Abidol hydrochloride; Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
Experimental: Oseltamivir was added on the basis of group I.; Oseltamivir 75mg once,twice a day,2 weeks	Drug: Oseltamivir; Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
Experimental: Lopinavir/ritonavir was added on the basis of group I.; Lopinavir/ritonavir 500mg once,twice a day,2 weeks	Drug: Lopinavir/ritonavir; Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of disease remission	A: 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);	two weeks
Time for lung recovery	Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.	two weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of no fever	two weeks
Rate of respiratory symptom remission	two weeks
Rate of lung imaging recovery	two weeks
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery	two weeks
Rate of undetectable viral RNA	two weeks

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir; Oseltamivir
• Other Study ID Numbers: TJ20200128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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