Created at Source Raw Value Validated value
July 7, 2022, 1:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 23/03/2022: The study treatment of Favipiravir is 9 x 400 mg tablets (1800 mg) to be taken on day 1 (5 tablets AM; 4 tablets PM) and then 2 x 400 mg tablets (800 mg) twice daily for four days (maintenance dose) - a total of 25 tablets; over 5 days. The study treatment of Ivermectin will be 3 mg tablets once daily (300 \u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 27/01/2022: The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets; over 5 days. The study treatment of Ivermectin will be 3mg tablets once daily (300\u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 12/05/2021: The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets; over 5 days. The study treatment of Colchicine is 500mg tablet once daily for 14 days. The study treatment of Ivermectin will be 3mg tablets once daily (300\u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 26/04/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus Colchicine vs usual care plus Favipiravir. A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or l", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}]

Feb. 3, 2022, 6:30 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 27/01/2022: The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets; over 5 days. The study treatment of Ivermectin will be 3mg tablets once daily (300\u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 12/05/2021: The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets; over 5 days. The study treatment of Colchicine is 500mg tablet once daily for 14 days. The study treatment of Ivermectin will be 3mg tablets once daily (300\u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 26/04/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus Colchicine vs usual care plus Favipiravir. A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies. The evaluation of any new interventions will be governed by the master protocol; including adaptive and decision crit", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

May 20, 2021, 7:59 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current interventions as of 12/05/2021: The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets; over 5 days. The study treatment of Colchicine is 500mg tablet once daily for 14 days. The study treatment of Ivermectin will be 3mg tablets once daily (300\u00b5g/kg body weight) for 3 days. _____ Previous interventions as of 26/04/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus Colchicine vs usual care plus Favipiravir. A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies. The evaluation of any new interventions will be governed by the master protocol; including adaptive and decision criteria. In addition; the inclusion of any new interventions will require supplementary appendices to the protocol and SAP. The study treatment of Favipiravir is 9 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 tablets (800mg) twice daily for four days (maintenance dose). A total of 50 tablets; over 5 days. The study treatment of Colchicine is 500mg once daily (tablet)", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

May 5, 2021, 11:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current interventions as of 26/04/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus Colchicine vs usual care plus Favipiravir. A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies. The evaluation of any new interventions will be governed by the master protocol; including adaptive and decision criteria. In addition; the inclusion of any new interventions will require supplementary appendices to the protocol and SAP. The study treatment of Favipiravir is 9 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 tablets (800mg) twice daily for four days (maintenance dose). A total of 50 tablets; over 5 days. The study treatment of Colchicine is 500mg once daily (tablet) for 14 days. Previous intervention as of 18/01/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus inhaled budesonide (a steroid used to treat asthma). A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Jan. 30, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 18/01/2021: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus inhaled budesonide (a steroid used to treat asthma). A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies. The evaluation of any new interventions will be governed by the master protocol; including adaptive and decision criteria. In addition; the inclusion of any new interventions will require supplementary appendices to the protocol and SAP. The study treatment is 400 \u00b5g/day budesonide as Pulmicort turbohaler\u00ae. Participants in this arm will take 2 puffs twice a day for 14 days. The comparator is usual care. _____ Previous intervention as of 01/10/2020: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus doxycycline (an antibiotic). A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment o", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current interventions as of 16/06/2020: The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus azithromycin (a commonly used antibiotic that is anti-inflammatory; treats community acquired pneumonia and bacterial chest infections; and has antiviral properties). A platform trial; in contrast to say a traditional two-arm design; allows multiple arms to be considered simultaneously; and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies. The evaluation of any new interventions will be governed by the master protocol; including adaptive and decision criteria. In addition; the inclusion of any new interventions will require supplementary appendices to the protocol and SAP. The study treatment is azithromycin 250mg capsules. Participants in this arm will take 500 mg (two capsules) once daily for 3 days. The capsules are for oral administration. The comparator is usual care. _____ Previous intervention as of 10/06/2020: The trial will initially be two-arm; comparing usual care to usual care with hydroxychloroquine or azithromycin treatment. The trial will be implemented in the first instance in practices that are already part of the RCGP RSC Network. Currently; over 500 practices are part of this network; with 100 already offering a sentinel viral s", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]