Early Use of Hyperimmune Plasma in COVID-19

NCT04721236 | Unknown

• 1 other identifier: 100490/2020
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale

Conditions

Covid19

Keywords

hyperimmune plasma; positive pressure respiratory support

Outcome Measures

Primary Outcomes (1)

• Clinical improvement (efficacy)

  Clinical improvement is obtained when a patient decreases his/her score by 2 points on the ten-category ordinal WHO scale or is discharged alive from the hospital, whichever comes first. The WHO scale is chosen in accordance with the "Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme" recently published in Lancet Infectious Diseases (WHO, 2020).

  28 days

Secondary Outcomes (26)

• ventilation

  Days: from 0 to 7, 14 and 28

• WHO (World Health Organization) scale

  From day 0 to 28 days

• SOFA (Sequential Organ Failure Assessment) score

  Days: from 0 to 7, 14 and 28

• naso-pharyngeal swab

  Days: from 0 to 7, 14 and 28

• SARS-CoV2

  28 days

Study Arms (1)

Single

EXPERIMENTAL

hyperimmune plasma with titre 1:80 or more

Other: hyperimmune plasma

Interventions

hyperimmune plasma OTHER

plasma collected from convalescent Covid-19 donors with titre 1:80 or more

Single

Eligibility Criteria

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

You may qualify if:

• Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
• Male or female adult patient ≥18 years of age at time of enrolment.
• Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
• Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
• No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
• Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
• The patient is not eligible in the Tsunami trial.

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19.
• In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30).
• Pregnancy
• Current documented and uncontrolled bacterial infection.

Sponsors & Collaborators

• Catherine Klersy: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

Catherine Klersy

Pavia, 27100, Italy

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

• Francesco Mojoli, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Statistician

Model Details: a multiple center, one arm clinical trial

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: November 19, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

IT (1)