Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 2 Study to Evaluate Bucillamine as a Potential Treatment for long COVID-19

Next Previous
Trial Profile

A Phase 2 Study to Evaluate Bucillamine as a Potential Treatment for long COVID-19

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 02 Apr 2024

Print Profile Download Citation

At a glance

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

    • Most Recent Events

    • 27 Mar 2024 According to a Revive Therapeutics media release, the company has submitted a Type C meeting request package to the U.S. Food & Drug Administration for the evaluation of a proposed clinical study of Bucillamine; Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
    • 19 Mar 2024 According to a Revive Therapeutics media release, the FDA has advised the Company to submit a Type C meeting request to discuss evaluating a proposed Phase 2 clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The Company expects to submit the Type C meeting request by next week.
    • 08 Apr 2020 According to a Revive Therapeutics media release, company has retained Novotech to serve as the Company CRO to pursue future human clinical studies for Bucillamine in the treatment of infectious diseases, including the coronavirus disease (COVID-19) in Asia-Pacific Countries.

Trial Overview

Purpose

This phase II study will evaluate Bucillamine as a potential treatment of COVID-19 patients with mild to moderate symptoms.

Other Endpoints

Disease course, safety and the time to clinical improvement. [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female

Patient Inclusion Criteria

COVID-19 patients with mild to moderate symptoms

Trial Details

Organisations

  • Affiliations Revive Therapeutics

Trial Dates

Other Details

  • Design double-blind; multicentre; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
BucillaminePrimary Drug
-
-

Bucillamine

Trial History

Event Date Event Type Comment
27 Mar 2024 Other trial event According to a Revive Therapeutics media release, the company has submitted a Type C meeting request package to the U.S. Food & Drug Administration for the evaluation of a proposed clinical study of Bucillamine; Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting. Updated 02 Apr 2024
19 Mar 2024 Other trial event According to a Revive Therapeutics media release, the FDA has advised the Company to submit a Type C meeting request to discuss evaluating a proposed Phase 2 clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The Company expects to submit the Type C meeting request by next week. Updated 25 Mar 2024
08 Apr 2020 Other trial event According to a Revive Therapeutics media release, company has retained Novotech to serve as the Company CRO to pursue future human clinical studies for Bucillamine in the treatment of infectious diseases, including the coronavirus disease (COVID-19) in Asia-Pacific Countries. Updated 13 Apr 2020
03 Apr 2020 Other trial event According to an Revive Therapeutics media release, the company will rely on its previous FDA IND submissions of Bucillamine to expedite communications and obtain FDA acceptance to proceed to a phase 2 clinical study. Updated 07 Apr 2020
01 Apr 2020 New trial record New trial record Updated 01 Apr 2020
30 Mar 2020 Other trial event According to an Revive Therapeutics media release, the Company is finalizing its regulatory package and clinical study plan for Bucillamine in the treatment of COVID-19 and it will submit for regulatory approval, by way of an IND application submission to the U.S. FDA, to investigate Bucillamine in a proposed Phase 2 clinical study. Updated 01 Apr 2020
25 Mar 2020 Other trial event According to a Revive Therapeutics media release, the Company has retained Pharm-Olam, LLC to serve as the Companys Contract Research Organization (CRO) in order to investigate Bucillamine as a potential treatment for COVID-19 in this U.S. FDA clinical study and in other infectious diseases clinical studies in the future. Updated 01 Apr 2020

References

  1. Revive Therapeutics. Revive Therapeutics Announces Filing of FDA Pre-IND Meeting. Media-Rel 2020;.

    Media Release

  2. Revive Therapeutics, Novotech. Revive Therapeutics Engages Novotech as Asia-Pacific CRO for Bucillamine in the Treatment of Infectious Diseases. Media-Rel 2020;.

    Media Release

  3. Revive Therapeutics. Revive Therapeutics Engages Pharma-Olam and Strengthens Infectious Diseases Clinical Development Team to Advance U.S. FDA Clinical Study for COVID-19. Media-Rel 2020;.

    Media Release

  4. Revive Therapeutics. Revive Therapeutics Submits Type C Meeting Request Package to FDA for Clinical Study of Bucillamine to Treat Long COVID. Media-Rel 2024;.

    Media Release

  5. Revive Therapeutics. Revive Therapeutics To Submit Type C Meeting Request with FDA for Bucillamine to Treat Long COVID. Media-Rel 2024;.

    Media Release

  6. Revive Therapeutics. Revive Therapeutics Provides Corporate Update on its COVID-19 and Infectious Diseases Programs. Media-Rel 2020;.

    Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG
Legal
Back to top