NCT04393727

Brief Summary

No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2. This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia. Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio \<150. Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity. Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening. Patients will be followed-up until 30 days from randomization.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

May 16, 2020

Last Update Submit

November 9, 2020

Conditions

COVIDSARS-CoV 2

Keywords

covid-19SARS-CoV2pneumoniaconvalescent plasma

Outcome Measures

Primary Outcomes (1)

  • Need of invasive mechanical ventilation

    Need of invasive mechanical ventilation defined as PaO2/FiO2 \<150

    30 days

Secondary Outcomes (5)

  • Mortality rates

    30 days

  • Time to invasive mechanical ventilation

    30 days

  • Time to virologic cure

    30 days

  • Length of hospital stay

    30 days

  • Adverse events

    30 days

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention group will receive 200 cc of convalescent plasma

Biological: CONVALESCENT PLASMA

Control

NO INTERVENTION

Patients will continue to receive standard therapy

Interventions

CONVALESCENT PLASMABIOLOGICAL

Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any gender
  • Age \> 18 years on day of signing informed consent
  • Informed written consent for participation in the study
  • Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
  • Hospitalized due to clinical instrumental diagnosis of pneumonia
  • PaO2/FiO2 ratio 200-350

You may not qualify if:

  • mechanical ventilation (both invasive and non-invasive)
  • PaO2/FiO2\<200
  • known hypersensitivity to immunoglobulin or blood components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Related Publications (1)

  • Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

    PMID: 32219428RESULT

MeSH Terms

Conditions

COVID-19Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Francesco Menichetti

    Azienda Ospedaliero, Universitaria Pisana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 19, 2020

Study Start

May 1, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)