Early Use of Hyperimmune Plasma in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2022-05-19

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a multiple center, one arm clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single

hyperimmune plasma with titre 1:80 or more

Group Type EXPERIMENTAL

hyperimmune plasma

Intervention Type OTHER

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

Interventions

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hyperimmune plasma

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No