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Completed

NCT Number: NCT04645407

Effects of Fuzheng Huayu Tablets on COVID-19

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shuguang Hospital

Shanghai, Shanghai Municipality, 201203, China

About this study

In December 2019, new coronavirus pneumonia (NCP) occurred in Wuhan, Hubei Province, which spread rapidly. Some of the patients developed into severe or critical illness. It became an international concerned public health emergencies and one of the major epidemics seriously endangering people's health and public safety after severe acute respiratory syndrome (SARS) in 2003.

At present, we lack the specific treatment for NCP. The anti- novel coronavirus drugs are been conducting in clinical trials, and the other options includes the symptomatic treatment. The pathological mechanism of the disease is not clear, but due to the continuous development of inflammation, some cases can become severe or critical, which threatening the life and health of patients. Intensive cases with obvious inflammation, after the control of acute symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery of lung function. Therefore, actively reducing lung inflammation, controlling and reversing pulmonary fibrosis is of great significance for the life and health of patients Infected novel coronavirus.

Our previous study found that Fuzheng Huayu prescription can reduce the inflammation and fibrosis of the lung in the model rats, and improve the lung function of the patients with COPD. Therefore, we hope to take Fuzheng Huayu tablet to NCP patients, and observe whether it can reduce the lung inflammation of patients, so as to reduce the rate of progression of critical illness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Fuzheng Huayu tablet

Drug

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

Primary outcomes

  1. the percentage of patients showing improvement in chest CT

    Time frame: Week 2

    Evaluation of the therapeutic effect of Fuzheng huayu tablet

Secondary outcomes

  1. remission rate or progression rate of critical illness

    Time frame: Week 2

    Evaluation of pulmonary inflammation improvement

  2. clinical remission rate of respiratory symptoms

    Time frame: week 2

    Evaluation of pulmonary inflammation improvement

  3. routine blood examination

    Time frame: Week 2

    Evaluation of pulmonary inflammation improvement

  4. C-reactive protein level

    Time frame: Week 2

    Evaluation of the therapeutic effect of Fuzheng huayu tablet

  5. procalcitonin level

    Time frame: Week 2

    Evaluation of pulmonary inflammation improvement

  6. oxygen saturation

    Time frame: Week 2

    Evaluation of pulmonary inflammation improvement

Sponsors and collaborators

Lead sponsor

ShuGuang Hospital

Other

Collaborators

  • Hubei Hospital of Traditional Chinese Medicine
  • Jingmen No.1 People's Hospital

Registry information

Official study title

Efficacy of Fuzheng Huayu Tablets for Treating Pulmonary Inflammation in Patients With COVID-19: A Case-Control Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2020
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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