Convalescent Plasma to Limit Coronavirus Associated Complications

Phase 2

Withdrawn

• Conditions: Coronavirus
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04325672
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

Detailed Description

High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Status Verified: 2020-04
• Study Start: 2020-04-01
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients must be 18 years of age or older
• Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
• Patient agrees to storage of specimens for future testing.

Exclusion Criteria

• Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma Group	Convalescent Plasma	Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of \>1:64.

Primary Outcome Measures

Name	Time	Method
RNA in SARS-CoV-2	Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion	Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
ICU Admissions	90 days after transfusion	Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Hospital Mortality	90 days after transfusion	Total number of subject deaths.
Hospital Length of Stay (LOS)	90 days after transfusion	The total number of days subjects were admitted to the hospital.

Secondary Outcome Measures

Name	Time	Method
Type of respiratory support	90 days after transfusion or until hospital discharge (whichever comes first)	The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
Duration of respiratory support	90 days after transfusion or until hospital discharge (whichever comes first)	The total number of days subjects required respiratory support.