Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)
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Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)

Sponsored by Johns Hopkins University


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.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study type: Interventional (Clinical Trial) Estimated Enrollment: 600 participants Actual Study Start Date: June 3, 2020 Estimated Study Completion Date: January 31, 2023

Who is this study for?

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Competent and capable to provide informed consent
  3. Positive RNA test for presence of SARS-CoV-2 in fluid collected by oropharyngeal or nasopharyngeal swab
  4. Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia.
  5. ≤ 8 days since the first symptoms of COVID-19
  6. ≤ 8 days since first positive SARS-CoV-2 RNA test
  7. Able and willing to comply with protocol requirements listed on the informed consents

Exclusion Criteria:

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

What should I expect?

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.

Have a question?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you’ll be connected to the study team.