Status:
UNKNOWN
Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
Lead Sponsor:
Peking University First Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Detailed Description
In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian ...
Eligibility Criteria
Inclusion
- Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);
- Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;
- High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);
- Voluntarily participate in research and sign informed consent.
Exclusion
- Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;
- Have been diagnosed with connective tissue disease;
- Pregnant or lactating women;
- History of mental disorders, substance abuse or dependence;
- Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;
- Researchers consider it inappropriate to participate in research;
- Participating in other clinical research.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT04334265
Start Date
April 1 2020
End Date
December 1 2020
Last Update
April 24 2020
Active Locations (9)
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1
The Second People's Hospital of Fuyang
Fuyang, Anhui, China, 230022
2
Ezhou Central Hospital
Wuhan, Hubei, China, 430000
3
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, China, 430000
4
Jinyintan Hospital of Wuhan
Wuhan, Hubei, China, 430000