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NCT04518410 · ClinicalTrials.gov registry record · Phase 2

ACTIV-2: A Study for Outpatients With COVID-19

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
4,044
Enrollment target

NCT04518410 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 4,044 participants.

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The verdict

NCT04518410, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
4,044 participants
Enrollment target

Study Summary

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Interventions

  • DRUG SNG001
  • BIOLOGICAL bamlanivimab 7000mg
  • BIOLOGICAL BRII-196+BRII-198
  • BIOLOGICAL AZD7442 (IV)
  • BIOLOGICAL AZD7442 (IM)

Trial Details

FieldValue
Enrollment Target 4,044 participants
Start Date 2020-08-19
Est. Completion 2023-06-20
Phase Phase 2

What the Registry Record Tells You About NCT04518410

The ClinicalTrials.gov registry entry for NCT04518410 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4,044 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which SNG001 is the first listed.

NCT04518410 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04518410 about?

NCT04518410 is a clinical study titled "ACTIV-2: A Study for Outpatients With COVID-19". Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need ho...

What is the current status of trial NCT04518410?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 4,044 participants. The study started on 2020-08-19. Estimated completion is 2023-06-20.

What interventions are being tested in trial NCT04518410?

The interventions under investigation include: SNG001 (DRUG), bamlanivimab 7000mg (BIOLOGICAL), BRII-196+BRII-198 (BIOLOGICAL), AZD7442 (IV) (BIOLOGICAL), AZD7442 (IM) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04518410?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.