Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    1344
  • sponsor
    Johns Hopkins University
Updated on 17 November 2020
fever
SARS
cough
oropharyngeal
anosmia
coronavirus infection

Summary

To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

Description

The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 600 eligible subjects stratified 50:50 in the <65 vs 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

Details
Treatment SARS-CoV-2 convalescent plasma, Plasma from a volunteer donor
Clinical Study IdentifierNCT04373460
SponsorJohns Hopkins University
Last Modified on17 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have SARS-CoV 2?
Do you have any of these conditions: Do you have SARS-CoV 2??
Do you have any of these conditions: Do you have SARS-CoV 2??
years of age
Competent and capable to provide informed consent
Positive RNA test for presence of SARS-CoV-2 in fluid collected by oropharyngeal or nasopharyngeal swab
Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5 F), cough, or other COVID associated symptoms like anosmia
days since the first symptoms of COVID-19
days since first positive SARS-CoV-2 RNA test
Able and willing to comply with protocol requirements listed in the informed consent

Exclusion Criteria

Hospitalized or expected to be hospitalized within 24 hours of enrollment
Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
History of prior reactions to transfusion blood products
Inability to complete therapy with the study product within 24 hours after enrollment
Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (off label like hydroxychloroquine, compassionate use or study trial related)
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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