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A randomized, double-blind, phase I/II clinical study of intranasal AdCOVID (coronavirus vaccine) for COVID-19

Trial Profile

A randomized, double-blind, phase I/II clinical study of intranasal AdCOVID (coronavirus vaccine) for COVID-19

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 01 Jun 2020

At a glance

  • Drugs Coronavirus vaccine-Altimmune (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors Altimmune
  • Most Recent Events

    • 01 Jun 2020 According to an Altimmune media release, Altimmune will host a conference call and webcast to discuss T-COVID on Monday, June 1.
    • 01 Jun 2020 According to an Altimmune media release, U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19
    • 01 Jun 2020 According to an Altimmune media release, this trial expected to commence in June with data readout expected in Q4 2020

Trial Overview

Purpose

This study will evaluate intranasal AdCOVID (coronavirus vaccine) for COVID-19.

The double-blind trial is expected to enroll approximately 100 patients who are 35 years and older randomized 1:1 to receive either intranasal T-COVID or placebo administered in an outpatient (non-hospitalized) setting within 48 hours of onset of symptoms and 24 hours of diagnosis.

The study will be enrolled in 3 cohorts of increasing risk factors for severe COVID-19, with the final cohort enrolling patients of all ages and risk factors.

Primary Endpoints

The primary efficacy endpoint is the proportion of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation (SpO2), or need for hospitalization.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 100

  • Sex male & female
  • Age Group ≥ 35 years; adult; elderly

Trial Details

Organisations

  • Sponsors Altimmune
  • Affiliations Altimmune

Trial Dates

  • Initiation Dates

    Planned : 01 Oct 2020

Other Details

  • Design double-blind; prospective; randomised
  • Phase of Trial Phase I/II
  • Location Unknown
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
Coronavirus vaccine-AltimmunePrimary Drug Nasal
-

Coronavirus-vaccine-Altimmune

Intranasal

Trial Centres

Centres

Centre Name Location Trial Centre Country
Altimmune, Inc.
-
-

Trial History

Event Date Event Type Comment
01 Jun 2020 Other trial event According to an Altimmune media release, Altimmune will host a conference call and webcast to discuss T-COVID on Monday, June 1. Updated 04 Jun 2020
01 Jun 2020 Other trial event According to an Altimmune media release, U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19 Updated 04 Jun 2020
01 Jun 2020 Other trial event According to an Altimmune media release, this trial expected to commence in June with data readout expected in Q4 2020 Updated 04 Jun 2020
13 May 2020 Other trial event According to an Altimmune media release, the company expects to initiate this study early as Q4 of this year. Updated 18 May 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020
27 Mar 2020 Other trial event According to an Altimmune media release, the company expects to initiate this study early as Q3 of this year. Updated 31 Mar 2020

References

  1. Altimmune. Altimmune Announces Financial Results for the Year Ended December 31, 2019 and Provides a Corporate Update. Media-Rel 2020;.

    Media Release
  2. Altimmune. Altimmune Announces First Quarter 2020 Financial Results and Provides a Business Update. Media-Rel 2020;.

    Media Release
  3. Altimmune. Altimmune Launches Clinical Trial of T-COVIDTM, an Investigational Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19. Media-Rel 2020;.

    Media Release
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