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NCT04421404: CAPRI

Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

Completed Phase 2 Results posted Last updated 7 October 2022
What this trial tests

Phase 2 trial testing COVID-19 Convalescent Plasma (CCP) in COVID-19 in 34 participants. Completed in 30 April 2021.

Timeline
9 June 2020
Primary endpoint
30 April 2021
30 April 2021

Quick facts

Lead sponsorPriscilla Hsue, MD
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment34
Start date9 June 2020
Primary completion30 April 2021
Estimated completion30 April 2021
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Priscilla Hsue, MD — full company profile →

Who can join

18 and older, any sex, with COVID-19 or Sars-CoV2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mechanical Ventilation or Death Endpoint Primary · Day 14

Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.

GroupValue95% CI
COVID-19 Convalescent Plasma2
Placebo0
Mechanical Ventilation or Death Endpoint Secondary · Day 28

Progression to mechanical ventilation or death within the first 28 days of enrollment.

GroupValue95% CI
COVID-19 Convalescent Plasma2
Placebo0
8-Point Ordinal Scale Endpoint Secondary · Day 29

Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale. 8 Point WHO Ordinal Scale of Clinical Status: Uninfected (No clinical or virological evidence of infection) - 0 Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2 Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4 Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intu

Day 1
GroupValue95% CI
COVID-19 Convalescent Plasma2.431 – 4
Placebo1.931 – 3
Day 2
GroupValue95% CI
COVID-19 Convalescent Plasma2.151 – 4
Placebo2.141 – 3.75
Day 3
GroupValue95% CI
COVID-19 Convalescent Plasma3.923 – 4
Placebo44 – 4
Day 4
GroupValue95% CI
COVID-19 Convalescent Plasma3.423 – 4
Placebo3.693.5 – 4
Day 5
GroupValue95% CI
COVID-19 Convalescent Plasma2.831 – 4
Placebo2.922.5 – 4
Day 6
GroupValue95% CI
COVID-19 Convalescent Plasma2.180.5 – 3.5
Placebo2.450 – 4
Day 7
GroupValue95% CI
COVID-19 Convalescent Plasma3.41 – 5
Placebo3.53 – 4
Day 8
GroupValue95% CI
COVID-19 Convalescent Plasma54.5 – 5.5
Placebo2.572 – 3.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COVID-19 Convalescent Plasma
Serious: 2/16 (13%)
Deaths: 1/16
Placebo
Serious: 1/18 (6%)
Deaths: 1/18

Serious adverse events (2 terms)

ReactionSystemCOVID-19 Convalescent PlasmaPlacebo
IntubationRespiratory, thoracic and mediastinal disorders
DeathGeneral disorders
Other adverse events (4 terms — click to expand)

ReactionSystemCOVID-19 Convalescent PlasmaPlacebo
Hypotension (transfusion reaction)Cardiac disorders
Elevated LFTsHepatobiliary disorders
UTIInfections and infestations
Elevated triglyceridesEndocrine disorders

Most-reported serious reactions: Intubation, Death.

Data from ClinicalTrials.gov NCT04421404 adverse events section.

Sponsor's own description

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

Publications & conference data

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

  1. 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
  2. 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
  3. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
  4. Treatment of COVID-19 with convalescent plasma: lessons from past coronavirus outbreaks.
    Wooding DJ, Bach H. · · 2020 · cited 55× · PMID 32791241 · DOI 10.1016/j.cmi.2020.08.005
  5. 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
  6. Humoral immune mechanisms involved in protective and pathological immunity during COVID-19.
    Widjaja G, Turki Jalil A, Sulaiman Rahman H, Abdelbasset WK, et al · · 2021 · cited 24× · PMID 34229864 · DOI 10.1016/j.humimm.2021.06.011
  7. Differential efficacy and safety of anti-SARS-CoV-2 antibody therapies for the management of COVID-19: a systematic review and network meta-analysis.
    Deng J, Heybati K, Ramaraju HB, Zhou F, et al · · 2023 · cited 22× · PMID 35438413 · DOI 10.1007/s15010-022-01825-8
  8. 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

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04421404.

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