Study Stopped
vaccination uptake 80% in the target population/new COVID variant
Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)
CoV-Early
1 other identifier
interventional
420
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Oct 2020
Typical duration for phase_3 covid19
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2020
CompletedStudy Start
First participant enrolled
October 12, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 1, 2022
March 1, 2022
12 months
October 12, 2020
March 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Highest disease status
Highest disease status on the 5-point ordinal disease severity scale in the convP group will be compared with the FFP group.
28 days following transfusion of convP or FFP
Secondary Outcomes (5)
Percentage of deaths
28 days following transfusion of convP or FFP
Percentage of hospital admissions
28 days following transfusion of convP or FFP
Percentage of ICU admissions
28 days following transfusion of convP or FFP
Disease duration in days of symptoms
28 days following transfusion of convP or FFP
Age and clinical frailty score
28 days following transfusion of convP or FFP
Other Outcomes (2)
Highest disease status stratified by presence of neutralizing antibodies and by symptom duration at baseline
28 days following transfusion of convP or FFP
Change in proportion of detectable SARS-Cov-2 RT-PCR results
Day 3, 7, 14 and 28 following transfusion of convP or FFP
Study Arms (2)
ConvP
EXPERIMENTAL300 mL convalescent plasma with a minimum of neutralizing antibodies
FFP
ACTIVE COMPARATOR300 mL Fresh Frozen plasma
Interventions
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
Infusion of thawed non-convalescent plasma Plasma will be administered according to the Erasmus Medical Center quality protocol regarding the use of blood products
Eligibility Criteria
You may qualify if:
- 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)
- years or older OR 50-69 years and 1 or more of the risk factors described in the protocol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Prothya Biosolutionscollaborator
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Leiden University Medical Centercollaborator
Study Sites (11)
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Bernhoven Hospital
Uden, Netherlands
Related Publications (1)
Millat-Martinez P, Gharbharan A, Alemany A, Rokx C, Geurtsvankessel C, Papageorgiou G, van Geloven N, Jordans C, Groeneveld G, Swaneveld F, van der Schoot E, Corbacho-Monne M, Ouchi D, Piccolo Ferreira F, Malchair P, Videla S, Garcia Garcia V, Ruiz-Comellas A, Ramirez-Morros A, Rodriguez Codina J, Amado Simon R, Grifols JR, Blanco J, Blanco I, Ara J, Bassat Q, Clotet B, Baro B, Troxel A, Zwaginga JJ, Mitja O, Rijnders BJA; CoV-Early study group; COnV-ert study group. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients. Nat Commun. 2022 May 11;13(1):2583. doi: 10.1038/s41467-022-29911-3.
PMID: 35546145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart Rijnders, MD, PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 12, 2020
First Posted
October 19, 2020
Study Start
October 12, 2020
Primary Completion
October 1, 2021
Study Completion
March 1, 2022
Last Updated
April 1, 2022
Record last verified: 2022-03