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

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ClinicalTrials.gov Identifier: NCT04292340
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hongzhou Lu, Shanghai Public Health Clinical Center

Tracking Information
First Submitted Date February 25, 2020
First Posted Date March 3, 2020
Last Update Posted Date March 3, 2020
Actual Study Start Date February 1, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2020)
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 [ Time Frame: 1 day after receiving plasma transmission ]
    The SARS-CoV-2 nuclei acid was quantified using RT-PCR
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after receiving plasma transmission ]
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after receiving plasma transmission ]
  • Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]
    Clinical outcomes include death, critical illness, recovery
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 28, 2020)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 4 weeks after receiving plasma transmission ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants received anti-SARS-CoV-2 inactivated convalescent plasma
Condition Coronavirus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2020)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Hongzhou Lu, Ph.D +86-021-37990333 ext 3222 luhongzhou@fudan.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04292340
Other Study ID Numbers Anti-SARS-CoV-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hongzhou Lu, Shanghai Public Health Clinical Center
Study Sponsor Shanghai Public Health Clinical Center
Collaborators Not Provided
Investigators
Principal Investigator: Hongzhou Lu, Ph.D Shanghai Public Health Clinical Center
PRS Account Shanghai Public Health Clinical Center
Verification Date February 2020