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

• Sponsor: Tongji Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04255017
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 80.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
2019-nCoV	Drug: Abidol hydrochloride; Drug: Oseltamivir; Drug: Lopinavir/ritonavir	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Symptomatic supportive treatment 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.

Outcome Measures

Primary Outcome Measures

1. Rate of disease remission [two weeks]

   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);

2. Time for lung recovery [two weeks]

   Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary Outcome Measures

1. Rate of no fever [two weeks]

2. Rate of respiratory symptom remission [two weeks]

3. Rate of lung imaging recovery [two weeks]

4. Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [two weeks]

5. Rate of undetectable viral RNA [two weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department and Institute of Infectious Disease	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qin Ning, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT04255017
• Other Study ID Numbers: TJ20200128
• First Posted: Feb 5, 2020
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Ritonavir; Lopinavir; Oseltamivir

Study Results

No Results Posted as of Mar 17, 2020