Clinical trial NCT04721236: Early Use of Hyperimmune Plasma in COVID-19
Official title: COVID-19 Wave II Study for Assessing the Early Use of Hyperimmune Plasma for the Treatment of COVID-19 Patients Needing Non-invasive or Invasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: hyperimmune plasma
positive pressure respiratory support
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2021-01-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a multiple center, one arm clinical trial
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical improvement (efficacy)
timeFrame: 28 days
Secondary outcomes:
measure: ventilation
timeFrame: Days: from 0 to 7, 14 and 28
measure: WHO (World Health Organization) scale
timeFrame: From day 0 to 28 days
measure: SOFA (Sequential Organ Failure Assessment) score
timeFrame: Days: from 0 to 7, 14 and 28
measure: naso-pharyngeal swab
timeFrame: Days: from 0 to 7, 14 and 28
measure: SARS-CoV2
timeFrame: 28 days
measure: P/F
timeFrame: Days: from 0 to 7, 14 and 28
measure: thrombosis
timeFrame: Days: from 0 to 7, 14 and 28
measure: curarization
timeFrame: Days: from 0 to 7, 14 and 28
measure: complication kidney
timeFrame: Days: from 0 to 7, 14 and 28
measure: complication lung
timeFrame: Days: from 0 to 7, 14 and 28
measure: Leucocytes
timeFrame: Days: from 0 to 7, 14 and 28
measure: Lymphocytes
timeFrame: Days: from 0 to 7, 14 and 28
measure: C-reactive protein
timeFrame: Days: from 0 to 7, 14 and 28
measure: D-dimer
timeFrame: Days: from 0 to 7, 14 and 28
measure: Troponin I (TnI)
timeFrame: Days: from 0 to 7, 14 and 28
measure: PCTI (Procalcitonin) (ng/mL)
timeFrame: Days: from 0 to 7, 14 and 28
measure: Ferritin
timeFrame: Days: from 0 to 7, 14 and 28
measure: Albumin
timeFrame: Days: from 0 to 7, 14 and 28
measure: LDH
timeFrame: Days: from 0 to 7, 14 and 28
measure: Lung Ultrasound Score (LUS)
timeFrame: Days: from 0 to 7, 14 , 28 and 6 months
measure: ecmo
timeFrame: 28 days
measure: death
timeFrame: 28 days, 3 and 6 months
measure: hospitalization
timeFrame: 28 days
measure: Lung Function tests
timeFrame: 6 months
measure: High resolution computed tomography (HRCT)
timeFrame: 6 months
measure: Improvement mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Catherine Klersy
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Francesco Mojoli, MD
role: PRINCIPAL_INVESTIGATOR
References: