NCT04463823

Brief Summary

NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to evaluate efficacy and safety of the treatment, as recommended by European health authorities. Patients who receive convalescent plasma in a clinical setting will be invited to participate in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on clinical parameters including virus load and recovery time will be collected and compared to european patients in a common database for the European countries. The treated patients can be compared to a historical control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

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

July 3, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

July 3, 2020

Last Update Submit

December 4, 2023

Conditions

COVID

Keywords

Convalescent plasma

Outcome Measures

Primary Outcomes (1)

  • observation

    clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis

    up to 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to health institutions where transfusion therapy is routinely given, and who are receiving COVID-19 convalescent plasma on a clinical indication as part of their treatment

You may qualify if:

  • patients treated with covid-19 convalescent plasma
  • patients who has provided informed consent or where nearest relative has given consent

You may not qualify if:

  • patients included in other clinical studies of covid-19 treatment
  • consent not given
  • All eligible patients should be invited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Helse Fonna

Haugesund, Norway

Location

Sorlandet hospital

Kristiansand, Norway

Location

Akershus University Hospital

Lørenskog, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Sykehuset Ostfold

Sarpsborg, Norway

Location

Sykehuset Telemark

Skien, Norway

Location

St.Olavs Hospital

Trondheim, Norway

Location

Study Officials

  • Lise Sofie Haug Nissen-Meyer, Ph.D.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project manager

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 9, 2020

Study Start

July 6, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2025

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

NO(7)