Early Use of Hyperimmune Plasma in COVID-19

Covid19 Clinical Trial

— COV-II-PLA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04721236
• Other study ID #: 100490/2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: May 19, 2022

Study information

• Verified date: March 2022
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Italy	Catherine Klersy	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Catherine Klersy	Fondazione IRCCS Policlinico San Matteo di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ventilation	Ventilator-free days	Days: from 0 to 7, 14 and 28
Secondary	WHO (World Health Organization) scale	WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)	From day 0 to 28 days
Secondary	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	Days: from 0 to 7, 14 and 28
Secondary	naso-pharyngeal swab	Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory	Days: from 0 to 7, 14 and 28
Secondary	SARS-CoV2	Log10 change in SARS-CoV2	28 days
Secondary	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)	Days: from 0 to 7, 14 and 28
Secondary	thrombosis	Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach	Days: from 0 to 7, 14 and 28
Secondary	curarization	Total duration of mechanical ventilation, ventilatory weaning and curarisation in days	Days: from 0 to 7, 14 and 28
Secondary	complication kidney	KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)	Days: from 0 to 7, 14 and 28
Secondary	complication lung	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	Days: from 0 to 7, 14 and 28
Secondary	Leucocytes	Biological efficacy endpoints: Leucocytes (x10^3/ul)	Days: from 0 to 7, 14 and 28
Secondary	Lymphocytes	Biological efficacy endpoints: Lymphocytes (x10^3/ul)	Days: from 0 to 7, 14 and 28
Secondary	C-reactive protein	Biological efficacy endpoints: C-reactive protein (mg/dL)	Days: from 0 to 7, 14 and 28
Secondary	D-dimer	Biological efficacy endpoints: D-dimer (ug/L)	Days: from 0 to 7, 14 and 28
Secondary	Troponin I (TnI)	Biological efficacy endpoints: TNI (ng/L)	Days: from 0 to 7, 14 and 28
Secondary	PCTI (Procalcitonin) (ng/mL)	Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)	Days: from 0 to 7, 14 and 28
Secondary	Ferritin	Biological efficacy endpoints: Ferritin (ng/ml)	Days: from 0 to 7, 14 and 28
Secondary	Albumin	Biological efficacy endpoints: Albumin (mg/dL)	Days: from 0 to 7, 14 and 28
Secondary	LDH	Biological efficacy endpoints: LDH (mU/mL)	Days: from 0 to 7, 14 and 28
Secondary	Lung Ultrasound Score (LUS)	Total Lung Ultrasound Score S score	Days: from 0 to 7, 14 , 28 and 6 months
Secondary	ecmo	Occurrence of ECMO implant	28 days
Secondary	death	All cause mortality	28 days, 3 and 6 months
Secondary	hospitalization	days total hospitalization and of ICU hospitalization	28 days
Secondary	Lung Function tests	Lung Function tests	6 months
Secondary	High resolution computed tomography (HRCT)	HRCT findings of the thorax	6 months
Secondary	Improvement mortality	rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry	28 days