You can go the FDA website on the CTAP program here:
Send your proposal to email@example.com
Advice for sponsors seeking to develop agents for the treatment of COVID-19:
The overall benefit-risk of this approach for the treatment of COVID-19 has not been established. The variability of individual clinical courses in COVID-19 and the incomplete understanding of this newly recognized disease can seriously affect the reliability of any conclusions based on uncontrolled data.
We strongly recommend that you propose a randomized placebo-controlled trial.
We recommend that you submit a draft protocol synopsis.
You should provide any data supporting the proposed use of your product in COVID-19.
You should provide a detailed justification for the proposed dose.
There are significant safety concerns in this patient population, both because of risks associated with the disease and because of the potential for adverse effects from the treatment that might be difficult to recognize. We recommend intensive safety monitoring and a DSMB.
It is hard to know how potential endpoints intended to demonstrate clinical benefit will perform. Identifying a number of potential endpoints to be studied in either a phase 2 or pilot phase of a proposed larger trial may be a reasonable approach until more information is available to support specific endpoints.
The size of the trial that would be reasonable may differ depending on the population intended for study (for example, various prophylaxis or treatment populations with different levels of risk) and the safety profile of the drug. Other considerations include whether the drug is an approved drug for another indication that you propose to repurpose for COVID-19 and for which you already have relevant safety data, or a new agent with limited human safety data.
We have a CDER multi-specialty multi-disciplinary team focused on review of these types of proposals. We recommend seeking initial advice under pre-IND. This can be converted to an IND when appropriate. Review and advice will be expedited and prioritized based upon the data provided.
For approved products seeking a new use or products in development under pre-IND or IND for another use, we recommend a new pre-IND for the proposed COVID-19 use. Please cross-reference any other NDA, BLA, or IND for the product.