COVID-19 Clinical Trial
Official title:
An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
Verified date | July 2021 |
Source | China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally.Given no specific antiviral therapy for CoVID-19 infection and the availability of Yinhu Qingwen Granula as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu Qingwen Granula in patients hospitalized with severe CoVID-19.
Status | Suspended |
Enrollment | 116 |
Est. completion date | April 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years at time of signing Informed Consent Form; 2. Those who meet the diagnosis of severe new coronavirus pneumonia with laboratory confirmed infection with CoVID-19; 3. Lung involvement confirmed with chest imaging; 4. Hospitalized with a Pa02/Fi02 ratio =300mgHg; 5. 40%> lymphocyte percentage =5%; 6. No difficulty swallowing oral medications. Exclusion Criteria: 1. Allergies, those who are known to be allergic to research drugs or drug excipients; 2. The patient weighs less than 40 kg; 3. Patients with diarrhea; 4. Shock; 5. Patients with respiratory failure at the time of enrollment who need invasive mechanical ventilation; 6. The clinician judges that ICU admission is needed; 7. Patients who participated in other clinical trials within 1 month; 8. Known patients with impaired renal function (estimated creatinine clearance <60 mL / min (male: Cr (ml / min) = (140-age) × body weight (kg) / 72 × blood creatinine concentration (mg / dl); female: Cr (ml / min) = (140-age) × weight (kg) / 85 × blood creatinine concentration (mg / dl)); 9. During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on the local laboratory reference range): ALT or AST level> 5 times the upper limit of normal range (ULN) or ALT or AST level> 3 times ULN and total bilirubin levels> 2 times ULN; 10. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months after study treatment; 11. Will be transferred to another hospital which is not the study site within 72 hours. |
Country | Name | City | State |
---|---|---|---|
China | Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University | Wuhan | Hubei |
China | Wuhan No.7 Hospital/Jizhong Energy Fengfeng Group Hospital | Wuhan | Hubei |
China | Wuhan No.7 Hospital/North China University of Science and Technology Affiliated Hospital | Wuhan | Hubei |
China | Zhongnan Hospital of Wuhan University/Tanshan People's Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Zhong Wang | Jizhong Energy Fengfeng Group Hospital, North China University of Science and Technology Affiliated Hospital, Tanshan People's Hospital, The First Affiliated Hospital of Dalian Medical University, Wuhan Leishenshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in the ratio of PaO2 to FiO2 from baseline | Day 10 | ||
Secondary | PaO2 | up to 30 days | ||
Secondary | blood oxygen saturation (SpO2) | up to 30 days | ||
Secondary | clinical status rating on the 7-point ordinal scale | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. | up to 30 days | |
Secondary | Time to Clinical Improvement (TTCI) | TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities). | up to 30 days | |
Secondary | Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use | up to 30 days | ||
Secondary | Duration (hours) of invasive mechanical ventilation use | up to 30 days | ||
Secondary | Duration (hours) of extracorporeal membrane oxygenation (ECMO) use | up to 30 days | ||
Secondary | Duration (days) of Oxygen use | up to 30 days | ||
Secondary | The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment | Day 10 | ||
Secondary | The counts/percentage of Lymphocyte | up to 30 days | ||
Secondary | Time to hospital discharge with clinical recovery from the randomisation | up to 30 days | ||
Secondary | The incidence of critical status conversion in 30 days | Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission. | up to 30 days | |
Secondary | All-cause mortality within 30 days | up to 30 days | ||
Secondary | Frequency of severe adverse drug events | up to 30 days |
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