Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292340
• Other study ID #: Anti-SARS-CoV-2
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, Ph.D
• Phone: +86-021-37990333
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

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