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:
- ≥ 18 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> 100.5º F), cough, or other COVID associated symptoms like anosmia.
- ≤ 8 days since the first symptoms of COVID-19
- ≤ 8 days since first positive SARS-CoV-2 RNA test
- Able and willing to comply with protocol requirements listed on the informed consents
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, 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.