Principal Investigator: Emily Spivak
Keywords: Clinical Trial , COVID-19 , Coronavirus , Convalescent plasma Department: Infectious Disease
IRB Number: 00135132
Specialty: Internal Medicine, General
Sub Specialties:
Recruitment Status: Active, not recruiting

Contact Information

Evan Heller
evan.heller@hsc.utah.edu
801-587-6293

Brief Summary

Primary Efficacy Objective:
Evaluate the efficacy of treatment with HCIP in reducing hospitalization and death 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.

Primary Efficacy Endpoint:

Cumulative incidence of COVID-19 related hospitalizations or deaths prior to hospitalization in treatment versus control groups by Day 28.

Primary Safety Objective:
Evaluate the safety of treatment with HCIP and control plasma in symptomatic outpatient subjects presenting with a positive SARS-CoV-2 RNA test.
 

Primary Safety Endpoints:

  • Cumulative incidence of treatment-related serious adverse events (SAE) categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period
  • Cumulative incidence of treatment-related grade 3 and 4 adverse events (AE) during the study period

Secondary Efficacy Endpoints:

  • Compare serum SARS-CoV-2 antibody titers between active and control groups at Days (-1 or 0), 14, 28 and 90.
  • Compare the rates and duration of SARS-CoV-2 RNA positivity (by RT-PCR) of nasopharyngeal or oropharyngeal fluid between active and control groups at days (-1 or 0), 14 and 28.

Tertiary Efficacy Endpoints

  • Compare the levels of SARS-CoV-2 RNA between active and control groups at days (-1 or 0), 14 and 28.
  • Compare time to hospital disease severity measured by ICU admission, invasive mechanical ventilation or time to death in hospital.
  • Assess rate of participant-reported secondary infection of household contacts
  • Compare blood oxygen saturation levels as measured by pulse oximetry (where available) between active and control groups through Day 28.
  • Assess time to resolution of COVID-19 symptoms based on temperature logs and symptom score sheets.
  • Assess treatment effect heterogeneity by age (as continuous variable).
  • Compare donor antibody titer to primary, secondary and tertiary endpoints

Study Design:
This randomized, double-blind, controlled, phase 2 trial will assess the efficacy and safety of HCIP to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding. Adults 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 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.
The following will be assessed in all subjects:

  • Clinical measures of safety and efficacy: Day 0 (baseline) to Day 28 and 90.
  • Serum antibody titer to SARS-CoV-2: Day (-1 or 0), 14, 28 and 90
  • SARS-CoV-2 RNA levels in fluid from nasopharyngeal or oropharyngeal swabs: Day (-1 or 0), 14 and 28.

Inclusion Criteria

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 saliva for antigen oropharyngeal or nasopharyngeal swab*

*Many sites such as Utah have moved away from oropharyngeal or nasopharyngeal swabs
and have replaced this with PCR saliva testing. This method of testing is an acceptable replacement for the oropharyngeal or nasopharyngeal swabs for the enrollment of participants.


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 consent

 

Exclusion Criteria

Exclusion Criteria: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 (monoclonal antibodies, off label, compassionate use or trial related). Steroid treatment at any time does not affect study eligibility.

Please see section 4 "Study Information" for details on vaccines in study subjects.