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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Recruiting
      • Shanghai Public Health Clinical Center
      • Contact: Jun Chen; Phone Number: 3222 008602137990333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants received anti-SARS-CoV-2 inactivated convalescent plasma

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	4 weeks after receiving plasma transmission

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Investigators: Principal Investigator: Hongzhou Lu, Ph.D, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ANTICIPATED): July 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (ACTUAL): March 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus; Plasma transfusion
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: Anti-SARS-CoV-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No