Coronavirus Clinical Trial
Official title:
The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - The participants were diagnosed as COVID-19; - Participants received anti-SARS-CoV-2 inactivated convalescent plasma - Written the informed consent. Exclusion Criteria: - Participants lacked detailed medical history |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Public Health Clinical Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 | The SARS-CoV-2 nuclei acid was quantified using RT-PCR | 1 day after receiving plasma transmission | |
Primary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after receiving plasma transmission | ||
Primary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after receiving plasma transmission | ||
Primary | Numbers of participants with different Clinical outcomes | Clinical outcomes include death, critical illness, recovery | From receiving plasma transmission to 4 weeks | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 4 weeks after receiving plasma transmission |
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