Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
COVID 19 Biological: Convalescent COVID 19 Plasma Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Convalescent COVID 19 Plasma
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject
Biological: Convalescent COVID 19 Plasma
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04516954


Locations
Layout table for location information
Vietnam
Vinmec Research Institute of Stem cell and Gene Technology
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
National Institute of Hygiene and Epidemiology, Vietnam
National Hospital for Tropical Diseases, Hanoi, Vietnam
National Institute of Hematology and Blood Transfusion, Vietnam
Layout table for additonal information
Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT04516954    
Other Study ID Numbers: ISC.20.11.1
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases