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Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Primary Purpose

Severe Acute Respiratory Syndrome Coronavirus 2

Status

Completed

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

COVID-19 convalescent plasma

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 focused on measuring Plasma, COVID-19, severe acute respiratory syndrome coronavirus 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient older than 18 years
CALL score ≥ 9 (progression risk score)
PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
Any symptoms of COVID-19 infection
Admission due to COVID-19 infection
Signed informed consent
ECOG before COVID-19 infection 0-2

Exclusion Criteria:

PaFi <200 or mechanical ventilation indication
Clinically relevant co-infection at admission
Pregnancy or lactation
IgA deficiency or IgA nephropathy
Immunoglobulin or plasma administration in the last 60 days
Contraindication to transfusion or previous allergy to blood-derived products
Do-not-resuscitate status
Patients receiving other investigational drug for COVID-19 in a clinical trial
Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

Sites / Locations

Hospital Clínico Universidad Católica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early COVID-19 convalescent plasma

COVID-19 convalescent plasma

Arm Description

COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility

COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for >7 days after enrolment

Outcomes

Primary Outcome Measures

Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization

Secondary Outcome Measures

Median duration of fever

Days

Median duration of mechanical ventilation

Days

Median length of ICU stay

Days

Median length of admission

Days

Hospital mortality rate (percentage)

30-day mortality (percentage)

Readmission rate (percentage)

Median length of viral clearance

days

Full Information

NCT ID

NCT04375098

First Posted

May 3, 2020

Last Updated

September 12, 2020

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Fundacion Arturo Lopez Perez

1. Study Identification

Unique Protocol Identification Number

NCT04375098

Brief Title

Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Official Title

Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

May 4, 2020 (Actual)

Primary Completion Date

August 17, 2020 (Actual)

Study Completion Date

August 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Fundacion Arturo Lopez Perez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

Plasma, COVID-19, severe acute respiratory syndrome coronavirus 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early COVID-19 convalescent plasma

Arm Type

Experimental

Arm Description

COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility

Arm Title

COVID-19 convalescent plasma

Arm Type

Experimental

Arm Description

COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for >7 days after enrolment

Intervention Type

Biological

Intervention Name(s)

COVID-19 convalescent plasma

Intervention Description

COVID-19 convalescent plasma

Primary Outcome Measure Information:

Title

Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization

Time Frame

1 year follow up

Secondary Outcome Measure Information:

Title

Median duration of fever

Description

Days

Time Frame

1 year

Title

Median duration of mechanical ventilation

Description

Days

Time Frame

1 year follow up

Title

Median length of ICU stay

Description

Days

Time Frame

1 year follow up

Title

Median length of admission

Description

Days

Time Frame

1 year follow up

Title

Hospital mortality rate (percentage)

Time Frame

1 year follow up

Title

30-day mortality (percentage)

Time Frame

1 year follow up

Title

Readmission rate (percentage)

Time Frame

1 year follow up

Title

Median length of viral clearance

Description

days

Time Frame

1 year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient older than 18 years CALL score ≥ 9 (progression risk score) PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact) Any symptoms of COVID-19 infection Admission due to COVID-19 infection Signed informed consent ECOG before COVID-19 infection 0-2 Exclusion Criteria: PaFi <200 or mechanical ventilation indication Clinically relevant co-infection at admission Pregnancy or lactation IgA deficiency or IgA nephropathy Immunoglobulin or plasma administration in the last 60 days Contraindication to transfusion or previous allergy to blood-derived products Do-not-resuscitate status Patients receiving other investigational drug for COVID-19 in a clinical trial Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Elvira Balcells, MD

Organizational Affiliation

ebalcells@uc.cl

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínico Universidad Católica

City

Santiago

Country

Chile

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34293119

Citation

Gharbharan A, GeurtsvanKessel CH, Jordans CCE, Blaauw M, van der Klift M, Hassing RJ, Smits-Zwinkels M, Meertens M, van den Hout EC, de Man AM, Hageman I, Bogers S, van der Schoot CE, Swaneveld F, Anas AA, Rokx C, Rijnders BJA. Effects of Treatment of Coronavirus Disease 2019 With Convalescent Plasma in 25 B-Cell-Depleted Patients. Clin Infect Dis. 2022 Apr 9;74(7):1271-1274. doi: 10.1093/cid/ciab647.

Results Reference

derived

PubMed Identifier

34013969

Citation

Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

Results Reference

derived

PubMed Identifier

33657114

Citation

Balcells ME, Rojas L, Le Corre N, Martinez-Valdebenito C, Ceballos ME, Ferres M, Chang M, Vizcaya C, Mondaca S, Huete A, Castro R, Sarmiento M, Villarroel L, Pizarro A, Ross P, Santander J, Lara B, Ferrada M, Vargas-Salas S, Beltran-Pavez C, Soto-Rifo R, Valiente-Echeverria F, Caglevic C, Mahave M, Selman C, Gazitua R, Briones JL, Villarroel-Espindola F, Balmaceda C, Espinoza MA, Pereira J, Nervi B. Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial. PLoS Med. 2021 Mar 3;18(3):e1003415. doi: 10.1371/journal.pmed.1003415. eCollection 2021 Mar.

Results Reference

derived

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Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

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