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Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)

NCT ID: NCT04390178

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-12-31

Brief Summary

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There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.

Detailed Description

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Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.

Conditions

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COVID-19

Keywords

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COVID-19 convalescent plasma treatment SARS-CoV-2 infection Safety Effectiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An open, non-randomised controlled, clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent plasma treatment

All participants will receive a bag of convalescent plasma. The bag volume will be 180-200 ml. The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions. The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines.

Group Type EXPERIMENTAL

SARS-CoV-2 convalescent plasma

Intervention Type BIOLOGICAL

Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection

Interventions

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SARS-CoV-2 convalescent plasma

Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 and \<81 years
* Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
* Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of \>20 breaths per minute without supplemental oxygen treatment
* A negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
* Written informed consent after meeting with a study physician and ability and willingness to complete follow up.

Exclusion Criteria

* No matching plasma donor (exact matching in both the ABO system and the Rh system is required)
* Unavailability of plasma
* Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
* Disease duration \>8 Days
* Estimated glomerular filtration rate \<60 (kidney failure stage III or more)
* Pregnancy (urinary-hcg), breast feeding,
* History of severe allergic reactions
* Inability to give informed consent
* Significantly compromised immunity.\*

* Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Joakim Dillner

OTHER

Sponsor Role lead

Responsible Party

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Joakim Dillner

Professor of Infectious Disease Epidemiology; Director of R&D

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Johan Ursing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital

Locations

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Danderyd Hospital

Danderyd, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CP1

Identifier Type: -

Identifier Source: org_study_id