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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

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.

Condition or disease Intervention/treatment Phase
COVID 19 Biological: Convalescent Plasma as Therapy for Covid-19 patients Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Official Title: Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 30, 2021

Arm Intervention/treatment
Experimental: Convalescent plasma
Standard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors
Biological: Convalescent Plasma as Therapy for Covid-19 patients
Patients in the treatment group will receive 500 ml from COVID-19 recovered donors

No Intervention: Standard of care
Standard of care (Supportive care, oxygen, antibiotics, no convalescent plasma)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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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
  • 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

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): NCT04521036


Contacts
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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

Locations
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Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
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
Investigators
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Principal Investigator: Liem Thanh Nguyen, PhD Vinmec Research Institute of Stem Cell and Gene Technology
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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT04521036    
Other Study ID Numbers: ISC.20.11.2
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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