Hyperimmune Plasma for Patients With COVID-19

NCT04614012 | Unknown DMC

• 1 other identifier: IMMUNO-COVID19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Conditions

Covid19

Keywords

covid19; Hospitalized patients; Hyperimmune plasma

Outcome Measures

Primary Outcomes (1)

• Death

  death from any cause

  within 30 days

Secondary Outcomes (5)

• time to extubation

  within 7 days

• length of intensive care unit stay

  within 7 days

• length of hospitalization

  within 30 days

• immune response

  at days 1, 3 and 7

• viral load

  at days 1, 3 and 7

Study Arms (1)

hyperimmune plasma

EXPERIMENTAL

treated with hyperimmune plasma

Other: treated with hyperimmune plasma

Interventions

treated with hyperimmune plasma OTHER

administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Also known as: hyperimmune plasma

hyperimmune plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>=18 yrs
• positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
• Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
• Polymerase chain reaction (PCR) positive
• signed informed consent unless unfeasible for the critical condition

You may not qualify if:

• proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
• consent denied

Sponsors & Collaborators

• ANNA FALANGA: lead

Study Sites (1)

Anna Falanga

Bergamo, 24127, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Therapeutics; COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Anna Falanga

CONTACT

+39 0352674776; afalanga@asst-ph23.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Model Details: Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 3, 2020
• Study Start: July 2, 2020
• Primary Completion: July 2, 2022
• Study Completion: July 2, 2022
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

IT (1)