Effects of Fuzheng Huayu Tablets on COVID-19

NCT04645407 | Completed Phase 4

• 1 other identifier: Fzhy-ncp-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory illness similar to SARS and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected 2019-nCoV, most of them should receive supportive care to help relieve symptoms. This clinical trial is to evaluate the effect of Fuzheng Huayu tablet on lung inflammation in intensive patients with novel coronavirus pneumonia and reduce the progressive rate to critical type.

Conditions

Novel Coronavirus Pneumonia

Outcome Measures

Primary Outcomes (1)

• the percentage of patients showing improvement in chest CT

  Evaluation of the therapeutic effect of Fuzheng huayu tablet

  Week 2

Secondary Outcomes (6)

• remission rate or progression rate of critical illness

  Week 2

• clinical remission rate of respiratory symptoms

  week 2

• routine blood examination

  Week 2

• C-reactive protein level

  Week 2

• procalcitonin level

  Week 2

Study Arms (2)

FZHY Group

EXPERIMENTAL

conventional therapy plus Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time.)

Drug: Fuzheng Huayu tablet

Control Group

NO INTERVENTION

conventional therapy

Interventions

Fuzheng Huayu tablet DRUG

Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)

FZHY Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were included if they (1) had COVID-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form.

You may not qualify if:

• Patients were excluded if they (1) had critical COVID-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade IV), severe liver or kidney disease, bronchial asthma, COPD, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.

Sponsors & Collaborators

• ShuGuang Hospital: lead
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Jingmen No.1 People's Hospital: collaborator

Study Sites (1)

Shuguang Hospital

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Interventions

fuzheng huayu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Director;PhD

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: November 27, 2020
• Study Start: February 1, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

CN (1)