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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04292340
Other study ID # Anti-SARS-CoV-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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