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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Coronavirus

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after receiving plasma transmission ]
  3. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after receiving plasma transmission ]
  4. Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]
    Clinical outcomes include death, critical illness, recovery


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 4 weeks after receiving plasma transmission ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants received anti-SARS-CoV-2 inactivated convalescent plasma
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292340


Contacts
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Contact: Hongzhou Lu, Ph.D +86-021-37990333 ext 3222 luhongzhou@fudan.edu.cn

Locations
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China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Jun Chen    008602137990333 ext 3222      
Sponsors and Collaborators
Shanghai Public Health Clinical Center
Investigators
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Principal Investigator: Hongzhou Lu, Ph.D Shanghai Public Health Clinical Center

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Responsible Party: Hongzhou Lu, professor, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT04292340    
Other Study ID Numbers: Anti-SARS-CoV-2
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongzhou Lu, Shanghai Public Health Clinical Center:
Plasma transfusion
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases