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NCT04354428 · ClinicalTrials.gov registry record · Phase 2

Treatment for COVID-19 in High-Risk Adult Outpatients

A Phase 2 study, sponsored by University of Washington.

Terminated
Registry status
Phase 2
Development phase
289
Enrollment target

NCT04354428: Clinical Trial Phase 2 study, sponsored by University of Washington.

NCT04354428 is a Phase 2 study that was terminated before completion, run by University of Washington. The registered enrollment target is 289 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04354428, a Phase 2 study, was terminated before completion, sponsored by University of Washington.

TERMINATED
Registry status
Phase 2
Development phase
289 participants
Enrollment target

Study Summary

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

Primary Outcome

Resting blood oxygen saturation (SpO2\<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough

Interventions

  • DRUG Azithromycin
  • DRUG Ascorbic Acid
  • DRUG Folic Acid
  • DRUG Hydroxychloroquine Sulfate
  • DRUG Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]

Trial Details

FieldValue
Enrollment Target 289 participants
Start Date 2020-04-16
Est. Completion 2020-11-30
Phase Phase 2
University of Washington

1,048 total trials

Why NCT04354428 stopped before completion

NCT04354428 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).

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

NCT04354428 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04354428 about?

NCT04354428 is a clinical study titled "Treatment for COVID-19 in High-Risk Adult Outpatients". This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract i...

What is the current status of trial NCT04354428?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2020-04-16. Estimated completion is 2020-11-30.

What interventions are being tested in trial NCT04354428?

The interventions under investigation include: Azithromycin (DRUG), Ascorbic Acid (DRUG), Folic Acid (DRUG), Hydroxychloroquine Sulfate (DRUG), Lopinavir 200 MG / Ritonavir 50 MG [Kaletra] (DRUG).

Who is sponsoring clinical trial NCT04354428?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04354428's enrollment target sits among peer trials

289 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04354428, the US trial registry maintained by the National Library of Medicine. NCT04354428 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.