NCT04375098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

May 3, 2020

Last Update Submit

September 12, 2020

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

PlasmaCOVID-19severe acute respiratory syndrome coronavirus 2

Outcome Measures

Primary Outcomes (1)

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

    1 year follow up

Secondary Outcomes (8)

  • Median duration of fever

    1 year

  • Median duration of mechanical ventilation

    1 year follow up

  • Median length of ICU stay

    1 year follow up

  • Median length of admission

    1 year follow up

  • Hospital mortality rate (percentage)

    1 year follow up

  • +3 more secondary outcomes

Study Arms (2)

Early COVID-19 convalescent plasma

EXPERIMENTAL

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

Biological: COVID-19 convalescent plasma

COVID-19 convalescent plasma

EXPERIMENTAL

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

Biological: COVID-19 convalescent plasma

Interventions

COVID-19 convalescent plasmaBIOLOGICAL

COVID-19 convalescent plasma

COVID-19 convalescent plasmaEarly COVID-19 convalescent plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universidad Católica

Santiago, Chile

Location

Related Publications (5)

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PMID: 37162745DERIVED

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PMID: 36734509DERIVED

  • 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.

    PMID: 34293119DERIVED

  • 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.

    PMID: 34013969DERIVED

  • 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.

    PMID: 33657114DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Maria Elvira Balcells, MD

    ebalcells@uc.cl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 5, 2020

Study Start

May 4, 2020

Primary Completion

August 17, 2020

Study Completion

August 17, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)