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

NCT ID: NCT04375098

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2020-08-17

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early COVID-19 convalescent plasma

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

Group Type: EXPERIMENTAL

COVID-19 convalescent plasma

Intervention Type: BIOLOGICAL

COVID-19 convalescent plasma

COVID-19 convalescent plasma

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

Group Type: EXPERIMENTAL

COVID-19 convalescent plasma

Intervention Type: BIOLOGICAL

COVID-19 convalescent plasma

Interventions

COVID-19 convalescent plasma

COVID-19 convalescent plasma

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Arturo Lopez Perez

OTHER

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Elvira Balcells, MD

Role: PRINCIPAL_INVESTIGATOR

ebalcells@uc.cl

Locations

Hospital Clínico Universidad Católica

Santiago, , Chile

Countries

Chile

References

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.

Reference Type: DERIVED

PMID: 37162745 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36734509 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34293119 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34013969 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33657114 (View on PubMed)

Other Identifiers

200415015

Identifier Type: -

Identifier Source: org_study_id