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

NCT04390178 | Completed Phase 1 DMC

• 1 other identifier: CP1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease progression

  Decrease in progression to requiring non-invasive or invasive ventilation

  28 days

Secondary Outcomes (9)

• Adverse events (AE)

  The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.

• Time ro resolution of fever and symptoms

  Until discharged from the hospital, up to 2 months

• Clearance of viraemia

  Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.

• Inflammatory parameter C-reactive protein (CRP)

  Until discharged from the hospital, up to 2 months

• Inflammatory parameter white blood cell count

  Until discharged from the hospital, up to 2 months

Study Arms (1)

Convalescent plasma treatment

EXPERIMENTAL

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.

Biological: SARS-CoV-2 convalescent plasma

Interventions

SARS-CoV-2 convalescent plasma BIOLOGICAL

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

Convalescent plasma treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent after meeting with a study physician and ability and willingness to complete follow up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joakim Dillner: lead
• Danderyd Hospital: collaborator
• Karolinska Institutet: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Danderyd Hospital

Danderyd, 182 57, Sweden

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Johan Ursing, MD, PhD

  Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Infectious Disease Epidemiology; Director of R&D

Model Details: An open, non-randomised controlled, clinical trial

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: May 15, 2020
• Study Start: April 10, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)