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NCT04516811

Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

Status unknown Phase 3 Last updated 25 September 2020
What this trial tests

Phase 3 trial testing COVID-19 convalescent plasma (CCP) plus standard of care (SOC) in COVID-19 in 600 participants. Status unknown.

Timeline
21 September 2020
Primary endpoint
30 December 2021
31 July 2022

Quick facts

Lead sponsorSouth African National Blood Service
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment600
Start date21 September 2020
Primary completion30 December 2021
Estimated completion31 July 2022
Sites2 locations across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

South African National Blood Service — full company profile →

Who can join

18 and older, any sex, with COVID-19 or SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
  3. COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.
    Focosi D, Franchini M, Pirofski LA, Burnouf T, et al · · 2022 · cited 79× · PMID 35262370 · DOI 10.1128/cmr.00200-21
  4. COVID-19 convalescent plasma: Interim recommendations from the AABB.
    Cohn CS, Estcourt L, Grossman BJ, Pagano MB, et al · · 2021 · cited 38× · PMID 33586160 · DOI 10.1111/trf.16328
  5. Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial).
    van den Berg K, Glatt TN, Vermeulen M, Little F, et al · · 2022 · cited 28× · PMID 35169169 · DOI 10.1038/s41598-022-06221-8
  6. Convalescent plasma for people with COVID-19: a living systematic review.
    Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
  7. Convalescent plasma for people with COVID-19: a living systematic review.
    Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
  8. Convalescent plasma (hyperimmune immunoglobulin) for COVID-19 management: An update.
    Chavda VP, Bezbaruah R, Dolia S, Shah N, et al · · 2023 · cited 10× · PMID 36741339 · DOI 10.1016/j.procbio.2023.01.018

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