deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT04480424

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit

Sponsor: Grifols Therapeutics LLC

Conditions COVID-19
Updated 12 times since 2020 Last updated: Oct 6, 2022 Started: Sep 17, 2020 Primary completion: Aug 25, 2021 Completion: Oct 25, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04480424, this PHASE2 trial focuses on COVID-19 and remains completed. Sponsored by Grifols Therapeutics LLC, it has been updated 12 times since 2020, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshotNot Yet Recruiting~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshotRecruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotRecruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotRecruiting~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshotRecruiting~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshotRecruiting~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshotRecruiting~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotActive Not Recruiting~Dec 2021 – ~Nov 2022 · 11 months · monthly snapshotCompleted~Nov 2022 – ~Jul 2024 · 20 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Nov 2022 — Jul 2024 [monthly]

    Completed PHASE2

  4. Dec 2021 — Nov 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  5. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

Show 7 earlier versions
  1. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  2. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  3. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  4. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  5. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  6. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  7. Aug 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
Data source: Grifols Therapeutics LLC

For direct contact, visit the study record on ClinicalTrials.gov .