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. 2020 Jul 10;2020(7):CD013600. doi: 10.1002/14651858.CD013600.pub2

NCT04385186.

Study name Inactivated convalescent plasma as a therapeutic alternative in hospitalized patients COVID‐19
Methods

  • Trial design: multicentre, single‐blind, clinical RCT

  • Sample size: 100 in each arm (60)

  • Setting: inpatient

  • Country: Colombia

  • Language: translated to English

  • Number of centres: 10
Participants Inclusion criteria:

  • >18 years

  • Confirmed laboratory diagnosis for qRT‐PCR to SARS‐CoV‐2

  • Meet any of the following medical criteria (defined by WHO): be currently hospitalised with: pneumonia, severe pneumonia, ARDS (moderate or severe), sepsis or septic shock

  • The patient, or his representative, must sign an informed consent


Exclusion criteria:

  • Participate in another clinical trial for COVID‐19

  • History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),

  • History of allergic reaction due to IgA deficiency

  • Allergic reaction to sodium citrate or riboflavin (vitamin B2)


History of immunosuppression
Interventions

  • Intervention(s): inactivated CP SARS‐Cov‐2 + support treatment under medical decision (day 0)

  • Details of CP:

    • Type of plasma: ABO‐Rh compatible inactivated CP SARS‐Cov‐2

    • Volume: 200 mL

    • Number of doses: 2, day 0 and day1

    • Antibody‐titre: NR

    • Pathogen inactivated: NR

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): transfusion day 0 and day 1

  • Comparator: support treatment, Day 0: start of support treatment selected by medical staff according to each institutional protocol

  • Concomitant therapy: NR

  • Treatment cross‐overs: no
Outcomes

  • Primary study outcome: mortality reduction in COVID‐19 patients treated with inactivated CP + support treatment

  • Primary review outcomes reported

    • All‐cause mortality at hospital discharge: 28‐day mortality (mortality reduction in COVID‐19 patients treated with inactivated CP + support treatment (time frame: over a period of 28 days)

    • Time to death: NR

  • Secondary review outcomes reported

    • Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): yes (incidence of AEs (time frame: up to 28 days)

    • Number of participants with SAEs: NR

    • Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: NR

    • 30‐day and 90‐day mortality: NR

    • Admission on the ICU: NR

    • Length of stay on the ICU: yes (ICU‐free days through Day 28 (time frame: until hospital discharge or a maximum of 28 days whichever comes first)

    • Time to discharge from hospital: yes (hospital‐free days through Day 60 (time frame: until hospital discharge or a maximum of 60 days whichever comes first)

    • QoL: NR

  • Additional study outcomes

    • Clinical evolution (time frame: over a period of 28 days)

    • Clinical evolution by 7‐parameter ordinal scale (time frame: 3, 7, 14 and 28 days)

    • Multi‐organ failure progression (time frame: 3, 7, 14 and 28 days)

    • Change in haemoglobin concentration (time frame: 3, 7, 14 and 28 days)

    • Change in blood cell count (time frame: 3, 7, 14 and 28 days)

    • Change in serum creatinine level (time frame: 3, 7, 14 and 28 days)

    • Change in AST level (time frame: 3, 7, 14 and 28 days)

    • Change in ALT level (time frame: 3, 7, 14 and 28 days)

    • Change in bilirubin level (time frame: 3, 7, 14 and 28 days)

    • Change in lactate dehydrogenase level (time frame: 3, 7, 14 and 28 days)

    • Change in creatine kinase level (time frame: 3, 7, 14 and 28 days)

    • Change in creatine kinase MB level (time frame: 3, 7, 14 and 28 days)

    • Change in CRP concentration (time frame: 3, 7, 14 and 28 days)

    • Change in D Dimer concentration (time frame: 3, 7, 14 and 28 days)

    • Change in procalcitonin concentration (time frame: 3, 7, 14 and 28 days)

    • Change in IL6 level (time frame: 3, 7, 14 and 28 days)

    • Radiography imaging (time frame: Over a period of 60 days)

    • Tomography imaging (time frame: Over a period of 60 days)

    • Assessment of oxygenation (time frame: 3, 7, 14 and 28 days)

    • Viral load (time frame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first)
Starting date 20 June 2020
Contact information Andrés F Zuluaga, MD, MSc, MeH  3014020291 andres.zuluaga@udea.edu.co
Ana L Muñoz, MSc, PhD ana.munoz@hemolifeamerica.org         
Notes

  • Recruitment status: not yet recruiting

  • Prospective completion date: 30 December 2020 estimated study completion date; 30 November 2020 (final data collection date for primary outcome measure)

  • Sponsor/funding: National Blood Center Foundation, Hemolife, Principal Investigator: Andrés F Zuluaga, MD, MSc, MeH, Universidad de Antioquia