Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

HIV Vaccine Trials Network

Status: Completed

Conditions: COVID-19; SARS-CoV-2

Treatments: Other: Sample collection

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT04403880

HVTN 405/HPTN 1901

5UM1AI068614-14 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19.

The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.

Full description

This study aims to characterize the SARS-CoV-2-specific immunity in convalescent individuals.

The observational cohort study will include 3 groups, as described in the table below.

Participants will complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR 2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits approximately 2 months, 4 months, and 1 year later. Participants diagnosed with SARS-CoV-2 infection at an optional follow-up visit may be contacted more frequently. Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.

Study visits may include physical examinations, medical history, questionnaires, pregnancy tests (for participants assigned female at birth), blood draws, optional nasal samples, and optional HIV testing.

Enrollment: 760 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 or older.
• Reports having had a positive test for SARS-CoV-2.
• Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment. Not excluded: individuals with symptoms consistent with residual sequelae of resolved COVID-19, in the clinical judgement of the investigator.
• Access to a participating HVTN or HPTN CRS and willingness to be followed for the planned duration of the study.
• Ability and willingness to provide informed consent.
• Assessment of understanding: volunteer demonstrates understanding of this study.
• Volunteers who were assigned female sex at birth: negative urine or serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 4 days of enrollment visit (ie, prior to enrollment blood draw or nasal collections). Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records) or having reached menopause (no menses for ≥ 1 year ), are not required to undergo pregnancy testing.

Exclusion criteria

• Reports current COVID-19.
• Pregnant.
• Receipt of SARS-CoV-2 specific antibodies (eg, convalescent plasma or sera, monoclonal antibodies, hyperimmune globulin). Not excluded: antibody therapy without SARS-CoV-2 specificity (eg, IL-6 pathway inhibitors for COVID-19).
• SARS-CoV-2 vaccine(s) received in a prior vaccine trial.
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent.

Trial design

760 participants in 3 patient groups

Group 1

Description:

Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 1A: Persons with asymptomatic infection, ages 18 through 55, inclusive * 1B: Persons with asymptomatic infection, age \> 55 * 1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55 * 1D: Persons with symptomatic infection (ie, COVID-19), age \> 55

Treatment:

Other: Sample collection

Group 2

Description:

Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 2A: Persons 18 through 55 years of age * 2B: Persons \> 55 years of age

Treatment:

Other: Sample collection

Group 3

Description:

Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)

Treatment:

Other: Sample collection