Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) (CoV-Early)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589949
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Sanquin Plasma Products BV
ZonMw: The Netherlands Organisation for Health Research and Development
Leiden University Medical Center
Information provided by (Responsible Party):
Bart Rijnders, Erasmus Medical Center

Brief Summary:

An effective, widely available, and safe treatment that can decrease the duration, severity and fatality of COVID-19 is urgently needed. Also, in the most affected regions the pressure on health care systems including ventilator support capacity can be a limiting factor for survival. Initial studies including from our group indicate that administering convalescent plasma containing high titers of neutralizing antibodies to COVID-19 patients who are already relatively late during the disease course after hospital admission is not effective, which can be explained by high titers of autologous antibodies present in patients. Thus, the antiviral capacity of convalescent plasma is hypothesized to be best positioned early in the disease course and in patients at increased risk for a severe disease course. If effective, any treatment that decreases the need for hospital admission is very valuable but so far, no COVID-19 treatment has been shown to prevent clinical deterioration when given before patients are admitted to the hospital.

Primary objective:

To evaluate the efficacy, feasibility and safety following the administration of convalescent plasma (ConvP) as a therapy for outpatients diagnosed with COVID-19 at increased risk for an unfavourable clinical outcome and within 7 days after symptom onset.

Study design:

This trial is a nationwide multicenter, double blind, randomized controlled trial in the Netherlands. Patients will be randomized between the transfusion of 300mL of convP versus regular fresh frozen plasma (FFP).

Patient population:

Patients with polymerase chain reaction (PCR) confirmed COVID disease with less than 8 days of symptoms, age 70 or older or 50-69 years with at least 1 additional risk factor for severe COVID-19 are eligible.

Intervention:

300mL of convP with a minimum level of neutralizing antibodies.

A total of 690 patients will be included. Expected duration of accrual: 18-24 months Duration of follow up :Day 28 for the primary endpoint


Condition or disease Intervention/treatment Phase
Covid19 Biological: ConvP Biological: FFP Phase 3

Detailed Description:

Secondary (exploratory) objectives

  • To evaluate the impact of 300mL convP on mortality
  • To evaluate the impact of 300mL convP on hospital admission
  • To evaluate the impact of 300mL convP on admission to ICU
  • To evaluate the impact of 300mL convP on duration of symptoms
  • To evaluate the impact of 300mL convP in relation to the age and clinical frailty of the patient

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)
Actual Study Start Date : October 12, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Arm Intervention/treatment
Experimental: ConvP
300 mL convalescent plasma with a minimum of neutralizing antibodies
Biological: ConvP

Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.

Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products

Other Name: convalescent plasma

Active Comparator: FFP
300 mL Fresh Frozen plasma
Biological: FFP
Infusion of thawed non-convalescent plasma Plasma will be administered according to the Erasmus Medical Center quality protocol regarding the use of blood products
Other Name: Fresh Frozen Plasma




Primary Outcome Measures :
  1. Highest disease status [ Time Frame: 28 days following transfusion of convP or FFP ]
    Highest disease status on the 5-point ordinal disease severity scale in the convP group will be compared with the FFP group.


Secondary Outcome Measures :
  1. Percentage of deaths [ Time Frame: 28 days following transfusion of convP or FFP ]
    Percentage of deaths in the convP group compared to the FFP group

  2. Percentage of hospital admissions [ Time Frame: 28 days following transfusion of convP or FFP ]
    Percentage of hospital admissions in the convP group compared to the FFP group

  3. Percentage of ICU admissions [ Time Frame: 28 days following transfusion of convP or FFP ]
    Percentage of ICU admissions in the convP group compared to the FFP group

  4. Disease duration in days of symptoms [ Time Frame: 28 days following transfusion of convP or FFP ]
    Disease duration in days of symptoms in the convP group compared to the FFP group

  5. Age and clinical frailty score [ Time Frame: 28 days following transfusion of convP or FFP ]
    Age and clinical frailty score stratified analysis of percentage of primary endpoint following transfusion of convP versus FFP.


Other Outcome Measures:
  1. Highest disease status stratified by presence of neutralizing antibodies and by symptom duration at baseline [ Time Frame: 28 days following transfusion of convP or FFP ]
    Analysis of primary endpoint following transfusion of convP versus FFP stratified by the presence of neutralizing antibodies at baseline and by symptom duration at baseline.

  2. Change in proportion of detectable SARS-Cov-2 RT-PCR results [ Time Frame: Day 3, 7, 14 and 28 following transfusion of convP or FFP ]
    Change in proportion of detectable SARS-CoV-2 RT-PCR results at day 3, 7, 14 and 28 following transfusion according to the presence of neutralizing antibodies at baseline



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:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RT-PCR-confirmed COVID-19.
  • Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoea, loss of taste or smell, diarrhea, falls or confusion)
  • 70 years or older OR 50-69 years and 1 or more of the risk factors described in the protocol

Exclusion Criteria:

  • Life expectancy <28 days in the opinion of the treating physician
  • Patient or legal representative is unable to provide written informed consent
  • Symptomatic for 8 days or more
  • Being admitted to the hospital at the informed consent procedure
  • Known previous history of transfusion-related acute lung injury
  • Known Immunoglobulin A (IgA) deficiency

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): NCT04589949


Contacts
Layout table for location contacts
Contact: Bart Rijnders, MD, PhD +31107033510 b.rijnders@erasmusmc.nl

Locations
Layout table for location information
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000 CA
Contact: Bart Rijnders, MD, PhD    +31104639222 ext 35339    b.rijnders@erasmusmc.nl   
Sub-Investigator: Casper Rokx, MD, PhD         
Sub-Investigator: Arvind Gharbharan, MD         
Sub-Investigator: Carlijn Jordans, MD         
Meander Medisch Centrum Not yet recruiting
Amersfoort, Netherlands
Contact: E. Jong, MD, PhD         
Rijnstate Ziekenhuis Not yet recruiting
Arnhem, Netherlands
Contact: Robert-Jan Hassing, MD, PhD         
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands
Contact: R.W. van Etten, MD, PhD         
Groene Hart Ziekenhuis Not yet recruiting
Gouda, Netherlands
Contact: Faiz Karim, MD, PhD         
University Medical Center Groningen (UMCG) Not yet recruiting
Groningen, Netherlands
Contact: D. Postma, MD, PhD         
Spaarne Gasthuis Not yet recruiting
Haarlem, Netherlands
Contact: Robin Soetekouw, MD         
Medisch Centrum Leeuwarden Not yet recruiting
Leeuwarden, Netherlands
Contact: L. Kampschreur, MD, PhD         
Leids Universitair Medisch Centrum Not yet recruiting
Leiden, Netherlands
Contact: JJ Zwaginga, MD/PhD         
Sint Antonius Ziekenhuis Not yet recruiting
Nieuwegein, Netherlands
Contact: Elana van Leeuwen, MD, PhD         
Bernhoven Hospital Not yet recruiting
Uden, Netherlands
Contact: I Ludwig, MD         
Sponsors and Collaborators
Erasmus Medical Center
Sanquin Plasma Products BV
ZonMw: The Netherlands Organisation for Health Research and Development
Leiden University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Bart Rijnders, MD, PhD Erasmus Medical Center
Layout table for additonal information
Responsible Party: Bart Rijnders, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04589949    
Other Study ID Numbers: NL74972.078.20
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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