Early Use of Hyperimmune Plasma in COVID-19
- Conditions
- Covid19
- Registration Number
- NCT04721236
- Lead Sponsor
- Catherine Klersy
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical improvement (efficacy) 28 days 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).
- Secondary Outcome Measures
Name Time Method ecmo 28 days Occurrence of ECMO implant
hospitalization 28 days days total hospitalization and of ICU hospitalization
WHO (World Health Organization) scale From day 0 to 28 days WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)
P/F Days: from 0 to 7, 14 and 28 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)
thrombosis Days: from 0 to 7, 14 and 28 Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach
C-reactive protein Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: C-reactive protein (mg/dL)
ventilation Days: from 0 to 7, 14 and 28 Ventilator-free days
SOFA (Sequential Organ Failure Assessment) score Days: from 0 to 7, 14 and 28 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
naso-pharyngeal swab Days: from 0 to 7, 14 and 28 Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory
Ferritin Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: Ferritin (ng/ml)
Lung Function tests 6 months Lung Function tests
High resolution computed tomography (HRCT) 6 months HRCT findings of the thorax
Lymphocytes Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: Lymphocytes (x10\^3/ul)
complication kidney Days: from 0 to 7, 14 and 28 KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)
complication lung Days: from 0 to 7, 14 and 28 Occurrence of ventilator-acquired pneumonia - Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal sampling
Leucocytes Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: Leucocytes (x10\^3/ul)
D-dimer Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: D-dimer (ug/L)
Troponin I (TnI) Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: TNI (ng/L)
PCTI (Procalcitonin) (ng/mL) Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)
Albumin Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: Albumin (mg/dL)
Lung Ultrasound Score (LUS) Days: from 0 to 7, 14 , 28 and 6 months Total Lung Ultrasound Score S score
death 28 days, 3 and 6 months All cause mortality
LDH Days: from 0 to 7, 14 and 28 Biological efficacy endpoints: LDH (mU/mL)
SARS-CoV2 28 days Log10 change in SARS-CoV2
curarization Days: from 0 to 7, 14 and 28 Total duration of mechanical ventilation, ventilatory weaning and curarisation in days
Improvement mortality 28 days rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry
Trial Locations
- Locations (1)
Catherine Klersy
🇮🇹Pavia, Italy
Catherine Klersy🇮🇹Pavia, Italy