Early Use of Hyperimmune Plasma in COVID-19

Catherine Klersy260 enrolled

Overview

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

Patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . Plasma titration will depend on the availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Covid19

Interventions

hyperimmune plasmaOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Male or female adult patient ≥18 years of age at time of enrolment. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen.. 4. 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) 5. No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day 6. Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS) 7. The patient is not eligible in the Tsunami trial. Exclusion Criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19. 2. 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. 3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30). 4. Pregnancy 5. Current documented and uncontrolled bacterial infection.

Locations (1)

Catherine Klersy

Pavia, Italy

Outcomes

Primary Outcomes

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).

Time frame: 28 days

Secondary Outcomes

ventilation

Ventilator-free days

Time frame: Days: from 0 to 7, 14 and 28

WHO (World Health Organization) scale

WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)

Time frame: From day 0 to 28 days

SOFA (Sequential Organ Failure Assessment) score

Sequential Organ Failure Assessment Score (SOFA score). This score is used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing with higher the scores

Time frame: Days: from 0 to 7, 14 and 28

naso-pharyngeal swab

Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory

Time frame: Days: from 0 to 7, 14 and 28

SARS-CoV2

Log10 change in SARS-CoV2

Time frame: 28 days

P/F

P/F ratio. P/F is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)

Data from ClinicalTrials.gov

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