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Clinical trial of Ampligen for use as a prophylactic/early-onset therapeutic against COVID-19.

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Trial Profile

Clinical trial of Ampligen for use as a prophylactic/early-onset therapeutic against COVID-19.

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 31 Mar 2020

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At a glance

  • Drugs Rintatolimod (Primary) ; Rintatolimod (Primary) ; Rintatolimod (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 26 Mar 2020 According to an AIM ImmunoTech media release, the company engaged ChinaGoAbroad (CGA) to facilitate pre-clinical and clinical trials of Ampligen in the People's Republic of China (PRC).
    • 26 Mar 2020 According to an AIM ImmunoTech media release, the company intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and governmental authorizations to commence the clinical trials of Ampligen.
    • 26 Mar 2020 According to an AIM ImmunoTech media release, the company is targeting the United States, Europe, Asia and Argentina for its clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development.

Trial Overview

Purpose

Clinical trial of Ampligen for use as a prophylactic/early-onset therapeutic against COVID-19

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention, treatment -

Subjects

  • Subject Type patients
  • Sex not stated

Trial Details

Organisations

  • Affiliations AIM ImmunoTech

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Phase I
  • Location Argentina; Asia; China; Europe; USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
RintatolimodPrimary Drug Intravenous
-
RintatolimodPrimary Drug Nasal
-
RintatolimodPrimary Drug Oral
-

Rintatolimod

Trial History

Event Date Event Type Comment
26 Mar 2020 Other trial event According to an AIM ImmunoTech media release, the company engaged ChinaGoAbroad (CGA) to facilitate pre-clinical and clinical trials of Ampligen in the People's Republic of China (PRC). Updated 31 Mar 2020
26 Mar 2020 Other trial event According to an AIM ImmunoTech media release, the company intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and governmental authorizations to commence the clinical trials of Ampligen. Updated 31 Mar 2020
26 Mar 2020 Other trial event According to an AIM ImmunoTech media release, the company is targeting the United States, Europe, Asia and Argentina for its clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development. Updated 31 Mar 2020
26 Mar 2020 Other trial event According to an AIM ImmunoTech media release, the company announced that it is actively seeking investigators and sites for clinical testing of Ampligen as a protective prophylaxis and an early-onset treatment for COVID-19. Updated 31 Mar 2020
03 Mar 2020 New trial record New trial record Updated 03 Mar 2020
02 Mar 2020 Other trial event According to an AIM ImmunoTech media release, Ampligen has a well-developed safety profile based on approximately 100,000 IV doses administered to humans and is ready to deploy for clinical trials in China if trials are approved by the PRC authorities and if Ampligen is authorized for export under the FDA regulations governing the export of investigational drugs for use in a sudden and immediate national emergency. Updated 03 Mar 2020

References

  1. AIM ImmunoTech. AIM ImmunoTech Joins with ChinaGoAbroad for an Ampligen China Entry Against COVID-19, the New SARS-like Coronavirus Disease Epidemic. Media-Rel 2020;.

    Media Release

  2. AIM ImmunoTech. AIM ImmunoTech Announces Further Efforts to Establish Clinical Trials Assessing Ampligen as a Potential Protective and Early-Onset Treatment for the Current COVID-19 Pandemic. Media-Rel 2020;.

    Media Release
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