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The efficacy of convalescent plasma in patients with critical novel coronavirus pneumonia (COVID-19): a pragmatic, prospective cohort study

The efficacy of convalescent plasma in patients with critical novel coronavirus pneumonia (COVID-19): a pragmatic, prospective cohort study

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031501
Enrollment
Unknown
Registered
2020-04-02
Start date
2020-03-17
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Group 1:Routine treatment + Infusion of convalescent plasma

Sponsors

Eastern theater General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) severe or critical patients with covid-19 pneumonia confirmed by novel coronavirus novel coronavirus diagnosis and treatment plan (seventh Edition); (2) 18-85 years old; (3) Obtaining informed consent;

Exclusion criteria

Exclusion criteria: (1) Patients who are participating in clinical trials of other drugs; (2) Pregnant or lactating women; (3) ALT / AST > 5-fold ULN, neutrophil < 0.5x10^9/L, platelet < 50x10^9/L; (4) The diagnosis of rheumatic immune related diseases was clear; (5) Long term oral anti rejection drugs or immunomodulatory drugs; (6) Hypersensitive reaction to mAb or any adjuvant; (7) Active tuberculosis patients with definite bacterial and fungal infection; (8) Patients with organ transplantation history within three months; (9) There was a history of PCI in the past 60 days; (10) COPD with end-stage chronic diseases, including NYHA heart failure above grade III, chronic kidney disease with CCR < 40 ml / min or requiring family oxygen therapy.

Design outcomes

Primary

MeasureTime frame
hospital mortality;

Secondary

MeasureTime frame
Time to 2019-nCoV RT-PCR negative in surviving patients;Time of medical imaging improvement;New receipt of high flow oxygen absorption;New receipt of non-invasive mechanical ventilation;New receipt of invasive mechanical ventilation;New receipt of CRRT;New receipt of ECMO;Lymphocyte count;C-reactive protein;IL-6;New onset of organ failure;New ICU admission rate;Length of hospital stay;Length of ICU stay (in ICU patients);Incidence of secondary bacterial infection;Incidence of secondary fungal infection;The incidence of critical illness in severe patients;Day90 mortality;Day90 readmission for COVID-19 pneumonia;

Countries

China

Contacts

Public ContactWeiqin Li

Eastern theater General Hospital

liweiqindr@vip.163.com+86 13951839654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026