Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hydroxychloroquine · 1 trial · 1 indication
To evaluate the feasibility of this protocol including participants' recruitment within the estimated time frame, i.e. understand the ability of the team to identify eligible participants, enroll them, retain them and follow them up until study completion.
To evaluate the utilization of tests and drug for this study in consideration with the limited availability of both for research purposes as reflected on the number of participants that got tested and received at least one dose of the drug.
To Determine the Safety profile for a previously well studied drug in this select group of HCP. Incidence of well described side effects would be studied over the course of the study and will be compared with the side effects and their prevalence as described in the Pharmacy manual for HCQ.
To evaluate the early efficacy of HCQ in high-risk, healthy volunteers in the prevention of acquiring COVID-19 while continuing to follow standard precautions that meet or exceed Centers of Disease Control (CDC) guidelines.
| Arm | Type | Description |
|---|---|---|
| Study arm - Hydroxychloroquine Sulfate (HCQ) | EXPERIMENTAL | HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth |
| Name | Type | Description |
|---|---|---|
| Hydroxychloroquine Sulfate (HCQ) | DRUG | Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ. |
Inclusion Criteria: * Volunteers ages 18 to 99 years, * Able to sign own informed consent form, * Considered high-risk healthcare care providers in a hospital setting with active exposure to COVID-19 infection. High-risk healthcare providers are defined as those actively working during the study d...
Hydroxychloroquine is being studied as a chemoprevention for COVID-19 in high-risk healthcare workers. It is an investigational small molecule in Phase 2 clinical development for this indication. The drug has not been approved for COVID-19 and remains under clinical investigation.
Hydroxychloroquine is being developed by Meridian Bioscience Inc, a company listed on the stock exchange under the ticker VIVO. The company is conducting clinical research to evaluate the drug's potential in preventing COVID-19 infection.
Hydroxychloroquine is in Phase 2 clinical development for COVID-19. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. The Phase 2 trial has been completed, and the drug is still in the clinical development process.
Hydroxychloroquine has one completed clinical trial registered under NCT04345653, titled 'Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers.' This Phase 2 study enrolled 48 participants in the United States and was an uncontrolled, non-randomized trial.
Hydroxychloroquine is a small molecule being investigated for COVID-19 prevention. The specific molecular target for this indication has not been disclosed in the available clinical trial information. The drug's mechanism of action in COVID-19 is under investigation.
Hydroxychloroquine is a distinct drug from chloroquine, though both are related compounds. The clinical trial data for Hydroxychloroquine in COVID-19 does not indicate that it is the same as chloroquine, and they are considered separate pharmaceutical agents.