philipn authored on Sept. 19, 2020, 7:39 p.m. | | Additions are marked like this |
This is a proposal for the UK's RECOVERY trial for COVID-19 therapeutics. See the UK government page for information on the proposal process. Name of Compound *Name of Proposer *Company Name (if applicable)PhoneEmail *1. What is the compound’s mechanism of action? *2. What is the compound’s route of administration?Please include information of PK/PD and justification of its dosage schedule, including any evidence for paediatric dosing. Note if supportive data is largely in vitro please justify the translation of in vitro dose to in vivo. 3. At what stage of development is the compound?e.g Phase 1, 2 or 3 or authorised medicine. If a combination therapy, please provide information around its administration of compounds individually and in combination 4. How many patients have been treated?5. What is the product’s safety profile?Please include information on the risk of drug drug interactions and outline any risk mitigation strategies. 6. Why in your view would the product have efficacy in COVID patients either in terms of the pathogenesis of the disease and/or its complications?7. At what stage of disease, based on the WHO ordinal scale for clinical improvement , would the product likely be administered?https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf 8. What is the product availability – in terms of patients numbers which could be treated?9. What is the likely scalability of production and supply?10. Is this compound being tested in any other clinical trials for COVID 19? If yes please indicate where and any trial details(Include possible attachments) | This is a proposal for the UK's RECOVERY trial for COVID-19 therapeutics. See the UK government page for information on the proposal process. Name of Compound *Name of Proposer *Company Name (if applicable)PhoneEmail *1. What is the compound’s mechanism of action? *2. What is the compound’s route of administration?Please include information of PK/PD and justification of its dosage schedule, including any evidence for paediatric dosing. Note if supportive data is largely in vitro please justify the translation of in vitro dose to in vivo. 3. At what stage of development is the compound?e.g Phase 1, 2 or 3 or authorised medicine. If a combination therapy, please provide information around its administration of compounds individually and in combination 4. How many patients have been treated?5. What is the product’s safety profile?Please include information on the risk of drug drug interactions and outline any risk mitigation strategies. 6. Why in your view would the product have efficacy in COVID patients either in terms of the pathogenesis of the disease and/or its complications?7. At what stage of disease, based on the WHO ordinal scale for clinical improvement , would the product likely be administered?https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf 8. What is the product availability – in terms of patients numbers which could be treated?9. What is the likely scalability of production and supply?10. Is this compound being tested in any other clinical trials for COVID 19? If yes please indicate where and any trial details(Include possible attachments) |
