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Convalescent Plasma for COVID-19 Patients (CPCP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516954
Recruitment Status : Enrolling by invitation
First Posted : August 18, 2020
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
National Hospital for Tropical Diseases, Hanoi, Vietnam
National Institute of Hematology and Blood Transfusion, Vietnam
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 18, 2020
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
Evaluate the safety [ Time Frame: At Day 28 ]
Number of Adverse Events (AEs), and Serious Adverse Events (SAEs) of COVID 19 Patients: Incidence of Treatment-Emergent Adverse Events (Data on the number of participants with treatment related adverse events will be assessed to determine the safety and tolerability of convalescent plasma)
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Evaluate the safety [ Time Frame: At Day 28 ]
Reduce Adverse Events (AEs), and Serious Adverse Events (SAEs) of COVID 19 Patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
Change in requirement for mechanical ventilatory support [ Time Frame: At Day 28 ]
Change in the duration of mechanical ventilation in COVID 19 patients compared with historic precedent cohorts
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma for COVID-19 Patients
Official Title  ICMJE Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Brief Summary The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. The first phase is to test the safety of CP therapy.
Detailed Description

Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic worldwide with a vast number of deaths such as severe acute respiratory syndrome-SARS (2003) with 8098 people infected and 774 people died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever, fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical presentation of respiratory distress, and increasing frequency of cardiovascular manifestations has become evident.

In this context, the investigators propose to evaluate the safety of intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation This is a single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.

Written informed consent will be obtained all eligible subjects prior to participation.

Convalescent plasma will be obtained from male donors, nulliparous females, or female donors negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID 19
Intervention  ICMJE Biological: Convalescent COVID 19 Plasma
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject
Study Arms  ICMJE Experimental: Convalescent COVID 19 Plasma
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject
Intervention: Biological: Convalescent COVID 19 Plasma
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  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 17, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-75 years
  • SARS-CoV-19 PCR positive
  • Medium stage
  • Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive

Exclusion Criteria:

  • Patients with a history of autoimmune disease or IgA deficiency
  • Patients with a history of allergy
  • Multi-organ/system failure
  • Pregnant or breastfeeding at the time of study
  • Cancer, history of heart failure, stroke, bronchial asthma
  • Multi-organ/system failure with indications for dialysis, severe hypoxia, failure with conventional treatment methods, indications for ECMO.
  • The patient is infected with multidrug-resistant bacteria.
  • The patient is participating in another study.
  • Time from onset to screening> 21 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04516954
Other Study ID Numbers  ICMJE ISC.20.11.1
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: No
Responsible Party Vinmec Research Institute of Stem Cell and Gene Technology
Study Sponsor  ICMJE Vinmec Research Institute of Stem Cell and Gene Technology
Collaborators  ICMJE
  • National Institute of Hygiene and Epidemiology, Vietnam
  • National Hospital for Tropical Diseases, Hanoi, Vietnam
  • National Institute of Hematology and Blood Transfusion, Vietnam
Investigators  ICMJE Not Provided
PRS Account Vinmec Research Institute of Stem Cell and Gene Technology
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP