Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19
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
1 other identifier
observational
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 3, 2020
February 1, 2020
6 months
February 25, 2020
February 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
3 days after receiving plasma transmission
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
7 days after receiving plasma transmission
Numbers of participants with different Clinical outcomes
Clinical outcomes include death, critical illness, recovery
From receiving plasma transmission to 4 weeks
Secondary Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
4 weeks after receiving plasma transmission
Eligibility Criteria
Participants received anti-SARS-CoV-2 inactivated convalescent plasma
You may qualify if:
- The participants were diagnosed as COVID-19;
- Participants received anti-SARS-CoV-2 inactivated convalescent plasma
- Written the informed consent.
You may not qualify if:
- Participants lacked detailed medical history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongzhou Lu, Ph.D
Shanghai Public Health Clinical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 3, 2020
Study Start
February 1, 2020
Primary Completion
July 31, 2020
Study Completion
December 31, 2020
Last Updated
March 3, 2020
Record last verified: 2020-02