Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) (CoV-Early)
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|ClinicalTrials.gov Identifier: NCT04589949|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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.
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.
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).
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.
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||690 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
300 mL convalescent plasma with a minimum of neutralizing antibodies
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
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
- 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.
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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
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
|Contact: Bart Rijnders, MD, PhDemail@example.com|
|Erasmus Medical Center||Recruiting|
|Rotterdam, Zuid-Holland, Netherlands, 3000 CA|
|Contact: Bart Rijnders, MD, PhD +31104639222 ext 35339 firstname.lastname@example.org|
|Sub-Investigator: Casper Rokx, MD, PhD|
|Sub-Investigator: Arvind Gharbharan, MD|
|Sub-Investigator: Carlijn Jordans, MD|
|Meander Medisch Centrum||Not yet recruiting|
|Contact: E. Jong, MD, PhD|
|Rijnstate Ziekenhuis||Not yet recruiting|
|Contact: Robert-Jan Hassing, MD, PhD|
|Amphia Ziekenhuis||Not yet recruiting|
|Contact: R.W. van Etten, MD, PhD|
|Groene Hart Ziekenhuis||Not yet recruiting|
|Contact: Faiz Karim, MD, PhD|
|University Medical Center Groningen (UMCG)||Not yet recruiting|
|Contact: D. Postma, MD, PhD|
|Spaarne Gasthuis||Not yet recruiting|
|Contact: Robin Soetekouw, MD|
|Medisch Centrum Leeuwarden||Not yet recruiting|
|Contact: L. Kampschreur, MD, PhD|
|Leids Universitair Medisch Centrum||Not yet recruiting|
|Contact: JJ Zwaginga, MD/PhD|
|Sint Antonius Ziekenhuis||Not yet recruiting|
|Contact: Elana van Leeuwen, MD, PhD|
|Bernhoven Hospital||Not yet recruiting|
|Contact: I Ludwig, MD|
|Principal Investigator:||Bart Rijnders, MD, PhD||Erasmus Medical Center|