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A study comparing two methods to obtain COVID -19 convalescent plasma: the hemofiltration method using gravity and the centrifugation method with spinning forces

Surplasma Access Trial: a prospective paired sample study comparing gravity-driven cross-flow membrane and mechanical centrifugal convalescent COVID-19 plasma production procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN21941624
Enrollment
10
Registered
2022-04-11
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

This is a prospective paired sample study where whole blood from each chosen patient is used for harvesting COVID-19 convalescent plasma using both the Hemoclear filter device and the centrifugal meth

Sponsors

Academic Hospital Paramaribo
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Were sick with a coronavirus infection (but do not need to have been hospitalized). Free of symptoms for at least 2 weeks (no more coughing, no fever, no cold symptoms, taste and smell are back). The infection must be proven by a test from B.O.G. or the Academic Hospital. 2. Weigh at least 50 kg 3. At least 18 years old 4. Never received blood or plasma transfusions in the past 5. In good health 6. Not have or not previously had hepatitis B, C, HIV or syphilis. This will be tested for. If participants do not want to know, they cannot participate in this study

Exclusion criteria

Exclusion criteria: Have or have previously had hepatitis B, C, HIV or syphilis or do not want to be tested for this

Design outcomes

Primary

MeasureTime frame
Total antibody load per ml in convalescent plasma, measured using a validated spike protein ELISA assay at the timepoint of production of convalescent plasma by either the centrifugal or microfiltration method (t1)

Secondary

MeasureTime frame
1. Procedure time, including setup and priming of the hemoclear filter and centrifugation system, measured as the time between the start of set-up (t0) and finishing the convalescent plasma procedure (t1) 2. Blood cell losses measured using Hemaocrit in convalescent plasma at timepoint t1 compared with whole blood Hematocrit at the donation timepoint (td) 3. Levels of IgG, IgM , IgA and fibrinogen measured from whole blood after collection of donor blood (td). After processing and production of convalescent plasma, samples are drawn to perform the same measurements (t1) in order to calculate the efficacy of removal. 4. Virus neutralization determined by measuring plasma neutralizing antibodies (nAbs) in the samples after production of CP (t1). The total plasma levels of antibodies against spike region S1 are measured using an ELISA assay. The nAb titer will be calculated as the highest plasma dilution that eliminated the cytopathic effect in 50% of the wells (NT50).

Countries

Suriname

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026