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Convalescent Plasma for COVID-19 Patients (CPCP) (CPCP)

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ClinicalTrials.gov Identifier: NCT04521036
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : September 1, 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 18, 2020
First Posted Date  ICMJE August 20, 2020
Last Update Posted Date September 1, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
Change in mortality [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]
Change in mortality of high risk COVID 19 disease compared with the control arm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • Change in requirement for mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]
    Change in the duration of mechanical ventilation in high risk COVID 19 disease compared with the control arm
  • Change in the duration of mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]
    Change in the time a participant will remain on the ventilator
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first ]
    Incidence of Treatment-Emergent Adverse Events during study period
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Change in requirement for mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]
    Change in the duration of mechanical ventilation in high risk COVID 19 disease compared with the control arm
  • Change in the duration of mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]
    Change in the time a participant will remain on the ventilator
  • Safety evaluation [ Time Frame: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first ]
    Incidence of Treatment-Emergent Adverse Events
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 (CPCP)
Official Title  ICMJE Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Brief Summary Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. 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. This phase is to test the safety and efficacy of CP therapy.
Detailed Description

Coronaviruses are among the most common causes of the common cold in humans. In recent decades, coronavirus has caused several epidemics 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 and efficacy 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 randomized clinical trial comparing convalescent plasma with the standard of care therapy in patients hospitalized for COVID-19 in Vietnam. Patients were randomized 1:1 and received 500 ml of plasma with anti-SARSCoV-2 neutralizing antibody titers of at least 1:80.

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 Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID 19
Intervention  ICMJE Biological: Convalescent Plasma as Therapy for Covid-19 patients
Patients in the treatment group will receive 500 ml from COVID-19 recovered donors
Study Arms  ICMJE
  • Experimental: Convalescent plasma
    Standard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors
    Intervention: Biological: Convalescent Plasma as Therapy for Covid-19 patients
  • No Intervention: Standard of care
    Standard of care (Supportive care, oxygen, antibiotics, no convalescent 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-75 years
  • SARS-CoV-19 PCR positive
  • Moderate stage and above
  • 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: Phuong Hoang Nguyen, MPH (+84) 39756885 ext 2321 v.phuongnh9@vinmec.com
Contact: Liem Thanh Nguyen, PhD (+84) 39756885 ext 2308 v.liemnt@vinmec.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04521036
Other Study ID Numbers  ICMJE ISC.20.11.2
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
Principal Investigator: Liem Thanh Nguyen, PhD Vinmec Research Institute of Stem Cell and Gene Technology
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