Clinical trial NCT04375098: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Keywords: Plasma
COVID-19
severe acute respiratory syndrome coronavirus 2
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Fundacion Arturo Lopez Perez
First posted: 2020-05-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization
timeFrame: 1 year follow up
Secondary outcomes:
measure: Median duration of fever
timeFrame: 1 year
measure: Median duration of mechanical ventilation
timeFrame: 1 year follow up
measure: Median length of ICU stay
timeFrame: 1 year follow up
measure: Median length of admission
timeFrame: 1 year follow up
measure: Hospital mortality rate (percentage)
timeFrame: 1 year follow up
measure: 30-day mortality (percentage)
timeFrame: 1 year follow up
measure: Readmission rate (percentage)
timeFrame: 1 year follow up
measure: Median length of viral clearance
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad Católica
Study officials:
affiliation: ebalcells@uc.cl
name: Maria Elvira Balcells, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.