IMPACC

This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.

Study phase: N/A

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:

  • Participant and/or surrogate understands the data to be collected and the study procedures and is willing to participate in the surveillance cohort as described in the study information sheet
  • ≥ 18 years of age at the time of hospitalization; and
  • Admitted to a hospital with presumptive or documented coronavirus disease 2019 (COVID-19), with confirmation of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection by Polymerase Chain Reaction (PCR).

Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:

  • Underlying medical problems which, in the opinion of the investigator may be associated with mortality unrelated to COVID-19 within 48 hours of hospitalization, or a decision by the patient or surrogate prior to hospitalization to limit care to comfort measures; or
  • Medical problems or conditions such as pregnancy which might impact interpretation of the immunologic data obtained

Primary disease category: COVID-19

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Protocol number: DAIT-COVID-19-002

Projected enrollment dates: May 2020 to March 2021

Official study title: A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients With COVID-19