A Phase 2 Study to Evaluate Bucillamine as a Potential Treatment for long COVID-19
Latest Information Update: 07 Feb 2025
At a glance
- Drugs Bucillamine (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; Therapeutic Use
Most Recent Events
- 03 Feb 2025 According to a Revive Therapeutics media release, the Company continues to finalize the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of Q1-2025. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q2-2025.
- 18 Sep 2024 According to a Revive Therapeutics media release, the company is finalizing the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q1-2025.
- 12 Jun 2024 According to a Revive Therapeutics media release, The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (IND) application and may cross-reference applicable sections from current IND that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in a Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and
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 | Target |
|---|---|---|---|
|
Bucillamine Primary Drug
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Bucillamine
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 03 Feb 2025 | Other trial event | According to a Revive Therapeutics media release, the Company continues to finalize the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of Q1-2025. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q2-2025. Updated 07 Feb 2025 |
| 18 Sep 2024 | Other trial event | According to a Revive Therapeutics media release, the company is finalizing the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q1-2025. Updated 24 Sep 2024 |
| 12 Jun 2024 | Other trial event | According to a Revive Therapeutics media release, The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (IND) application and may cross-reference applicable sections from current IND that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in a Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and Updated 14 Jun 2024 |
| 12 Jun 2024 | Other trial event | According to a Revive Therapeutics media release, The company received the Type C meeting written responses from the U.S. Food & Drug Administration. Updated 14 Jun 2024 |
| 23 Apr 2024 | Other trial event | According to a Revive Therapeutics media release, company announced Type C meeting request granted by FDA for clinical study of bucillamine to treat long COVID. The meeting date assigned by the FDA is June 9, 2024. Updated 25 Apr 2024 |
| 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
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Revive Therapeutics. Revive Therapeutics Announces Filing of FDA Pre-IND Meeting. Media-Rel 2020;.
Media Release -
Revive Therapeutics. Revive Therapeutics Announces Type C Meeting Request Granted by FDA for Clinical Study of Bucillamine to Treat Long COVID. Media-Rel 2024;.
Media Release -
Revive Therapeutics, Novotech. Revive Therapeutics Engages Novotech as Asia-Pacific CRO for Bucillamine in the Treatment of Infectious Diseases. Media-Rel 2020;.
Media Release -
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 -
Revive Therapeutics. Revive Therapeutics Announces Update on R&D Focus on Bucillamine for Infectious Diseases and Medical Countermeasures. Media-Rel 2025;.
Media Release -
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 -
Revive Therapeutics. Revive Therapeutics Provides Update on FDA Type C Meeting for Clinical Study of Bucillamine to Treat Long COVID. Media-Rel 2024;.
Media Release -
Revive Therapeutics. Revive Therapeutics Announces Strategic Focus on Bucillamine for Infectious Diseases and Medical Countermeasures. Media-Rel 2024;.
Media Release -
Revive Therapeutics. Revive Therapeutics To Submit Type C Meeting Request with FDA for Bucillamine to Treat Long COVID. Media-Rel 2024;.
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Revive Therapeutics. Revive Therapeutics Provides Corporate Update on its COVID-19 and Infectious Diseases Programs. Media-Rel 2020;.
Media Release
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