Convalescent Plasma in the Treatment of Covid-19

NCT04730401 | Unknown Phase 2

• 1 other identifier: Plasma_Covid-19
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the possible adverse effects and effectiveness of convalescent plasma for patients infected with SARS-CoV-2. Following provision of informed consent, patients will be randomized into three groups: High-titre convalescent plasma, low-titre convalescent plasma or placebo. Primary outcomes of the study will cover safety and either intubation or initiation of systemic corticosteroids. Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Microbiological and other laboratory parameters will be followed up.

Conditions

Covid19

Keywords

Covid-19; Convalescent plasma; Safety

Outcome Measures

Primary Outcomes (3)

• Safety (SAE)

  Immediate serious adverse events (SAE) between active and non-active group

  SAEs will be reviewed, recorded and reported up to 6 hours after administration of CP or placebo.

• Safety (SAE)

  Subsequent serious adverse events (SAE) between active and non-active group

  SAEs will be recorded and reported up to 7 days after administration of CP or placebo.

• Rate of intubation or systemic corticosteroids initiation

  Intubation or systemic corticosteroid treatment (e.g. dexamethasone) started for aggravation of Covid-19

  21 days post transfusion

Secondary Outcomes (15)

• Hospital stay

  Through study completion, up to 1 year

• Mortality

  Through study completion, up to 1 year

• Mortality

  21 days post transfusion

• ICU stay

  Within 21 days post transfusion

• Ventilator days

  Within 21 days post transfusion

Study Arms (3)

High-titre CP

EXPERIMENTAL

200mL high-titre CP on admittance

Biological: Convalescent plasma from COVID-19 donors

low-titre CP

ACTIVE COMPARATOR

200ml low-titre CP on admittance

Biological: Convalescent plasma from COVID-19 donors

Placebo

PLACEBO COMPARATOR

200mL saline as placebo on admittance

Biological: Placebo

Interventions

Convalescent plasma from COVID-19 donors BIOLOGICAL

Convalescent plasma from COVID-19 donors

High-titre CP; low-titre CP

Placebo BIOLOGICAL

200mL saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Covid-19 disease at the time of recruitment laboratory-confirmed by upper respiratory tract PCR
• Patient recently (0-4 days earlier) admitted to hospital due to Covid-19 infection
• Symptom onset 10 days before recruitment (if symptom onset unknown the duration is calculated from positive PCR-test)
• the day should be recorded from the duration of the Covid-19 symptoms/positive test result
• The dose of LMWH thromboprofylaxis should be recorded
• Written informed consent.

You may not qualify if:

• Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded ( inhaled or topical steroids allowed)
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Pregnancy or lactation.
• Alcohol or drug abuse.
• Suspected non-compliance.
• Presence of VTE, including pulmonary embolism or other manifestations of thrombosis
• Use of any investigational drug (other than hydroxychloroquine) or vaccine within 30 days prior to first dose of study vaccine or planned use during study period.
• Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction as judged by investigator.
• Known immunoglobulin A (IgA) deficiency
• Existing treatment limitations: do-not-resuscitate (DNR) order or withholding treatment in ICU
• Any other criteria which, as judged by investigator, might compromise a patient's well-being or ability to participate in the study or its outcome.
• Active malignant disease
• CP not available for patients blood type
• Patient cannot assign written consent
• No personnel available for CP of placebo transfusion

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Finnish Red Cross Blood Service: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00270, Finland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anu Kantele, MD,Prof

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Some of the investigators are masked and some are not
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind, randomized, placebo controlled trial

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: January 27, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)