Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Minnesota
Study ID
NCT04910269
Phase
PHASE3
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) — BIOLOGICAL
    The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.
  • Placebo — OTHER
    Infusion of 35 milliliters standard isotonic saline

Study Details

The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory syndrome - coronavirus 2 (SARS-CoV2) infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.

Key Dates

Start date
Aug 6, 2021
Status verified
Jun 2026
Primary completion
May 24, 2026
Completion
Jun 16, 2026

Study Design

Enrollment
820 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Participants in this group will receive the investigational treatment in addition to standard of care.
  • Placebo Comparator: Placebo Group
    Participants in this group will receive a placebo in addition to standard of care.

Primary Outcome Measure

Clinical Status [ Time Frame: 7 days ]

Locations (16)

FacilityCityStateZIPSite coordinators
Southern Arizona VA Healthcare System (074-009)TucsonArizona85723-
VA Northern California Health Care System (074-023)MatherCalifornia95655-
Stanford University Hospital & Clinics (Site 203-003)Palo AltoCalifornia94305-
San Francisco VAMC (Site 074-002)San FranciscoCalifornia94121-
Rocky Mountain Regional VA Medical Center (074-010)AuroraColorado80045-
Henry Ford Health System Site (014-001)DetroitMichigan48202-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Cleveland Clinic Foundation (Site 207-001)ClevelandOhio44195-
Penn State Health Milton S. Hershey Medical Center (209-002)HersheyPennsylvania17033-
CHRISTUS Spohn Shoreline HospitalCorpus ChristiTexas78404-
UT Southwestern Medical CenterDallasTexas75390-
Intermountain Medical Center (211-001)MurrayUtah84107-
UVA Health System, University Hospital (Site 210-003)CharlottesvilleVirginia22908-
Carilion Medical Center (Site 080-018)RoanokeVirginia24015-
Salem VA Medical Center (074-014)SalemVirginia24153-
Swedish Hospital First HillSeattleWashington98122-

Find similar trials in Tucson, AZ

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Southern Arizona VA Healthcare System (074-009)· Tucson, AZVA Northern California Health Care System (074-023)· Mather, CAStanford University Hospital & Clinics· Palo Alto, CASan Francisco VAMC· San Francisco, CARocky Mountain Regional VA Medical Center (074-010)· Aurora, COHenry Ford Health System Site (014-001)· Detroit, MI

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