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Yinhu Qingwen Decoction for Mild/Common COVID-19

NCT04278963Phase 3

Key facts

Status: Suspended
Start: Oct 2021
Primary completion: Dec 2022
Countries: 1
Sponsor: China Academy of Chinese Medical Sciences
Modality: Implantable Devices, Transdermal Patches, Inhalation Devices

Drugs: Yinhu Qingwen Granula
Conditions: coronavirus disease 2019 (COVID-19)

Overview

Phase 3, randomised, single-blind trial of Yinhu Qingwen Granula in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by China Academy of Chinese Medical Sciences. Primary endpoint: Mean clinical recovery time up to 28 days. Started Oct 2021; status: suspended.

Design

3 arms

Study design: RandomizedSingle-blind

Yin Hu Qing Wen Decoction Group
Yinhu Qingwen Decoction (Granula) + Standard Western Medicine for 10 days.
Yinhu Qingwen Decoction low-dose group
10% dose of Yinhu Qingwen Decoction (Placebo Comparator) + Standard Western Medicine for 10 days.
Integrated Chinese and Western Medicine group
Individualized Chinese medicine decoction + Standard Western Medicine for 10 days.

Who it enrols

Adult patients hospitalized with confirmed mild or common COVID-19 (fever and cough), without respiratory distress, shock, or severe organ impairment.

Endpoints

Primary

Mean clinical recovery timeup to 28 days

Secondary

Time to CoVID-19 RT-PCR negative in upper respiratory tract specimenup to 28 days
Change (reduction) in CoVID-19 viral load in upper respiratory tract specimenup to 28 days
Time to defervescenceup to 28 days
Time to cough reported as mild or absentup to 28 days
Time to dyspnea reported as mild or absentup to 28 days
Frequency of requirement for supplemental oxygen or non-invasive ventilationup to 28 days
Frequency of respiratory progressionup to 28 days
Severe case incidenceup to 28 days

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