Created at Source Raw Value Validated value
Feb. 3, 2022, 6:30 a.m. oms

Current participant exclusion criteria as of 27/01/2022: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible. 4. Previous randomisation to an arm of the PRINCIPLE trial 5. Known or suspected pregnancy 6. Breastfeeding 7. Women of childbearing potential (premenopausal female that is anatomically and physiologically capable of becoming pregnant*), or male with a partner of childbearing potential, not willing to use highly effective contraceptive** for the 28-day duration of the trial. As recorded by the participant on the screening form and confirmed on Day 1 by a call between clinician and participant * Highly effective methods have typical-use failure rates of less than 1% and include male or female sterilisation and long-acting reversible contraceptive (LARC) methods (intrauterine devices and implants) OR if a couple is using another method of contraception, such as a combined hormonal method, progestogen-only pill or injection, they are only eligible if they are willing to use an additional barrier method (e.g. male condom) for the 28-day duration of follow-up in the trial. Note: a barrier method on its own is not sufficient. Previous participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusion criteria specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hos

Current participant exclusion criteria as of 27/01/2022: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible. 4. Previous randomisation to an arm of the PRINCIPLE trial 5. Known or suspected pregnancy 6. Breastfeeding 7. Women of childbearing potential (premenopausal female that is anatomically and physiologically capable of becoming pregnant*), or male with a partner of childbearing potential, not willing to use highly effective contraceptive** for the 28-day duration of the trial. As recorded by the participant on the screening form and confirmed on Day 1 by a call between clinician and participant * Highly effective methods have typical-use failure rates of less than 1% and include male or female sterilisation and long-acting reversible contraceptive (LARC) methods (intrauterine devices and implants) OR if a couple is using another method of contraception, such as a combined hormonal method, progestogen-only pill or injection, they are only eligible if they are willing to use an additional barrier method (e.g. male condom) for the 28-day duration of follow-up in the trial. Note: a barrier method on its own is not sufficient. Previous participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusion criteria specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hos

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

Current participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusion criteria specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolid

Current participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusion criteria specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolid

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

Current participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusions specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolides

Current participant exclusion criteria as of 26/04/2021: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Previous randomisation to an arm of the PRINCIPLE trial Additional exclusions specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm. Previous participant exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolides

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

Current exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolides 5.12. Known congenital or documented QT prolongation 5.13. Known retinal disease 6. Exclusion criteria related to azithromycin: 6.1. Pregnancy 6.2. Breastfeeding 6.3. Known severe hepatic impairment 6.4. Known severe renal impairment 6.5. Known myasthenia gravis 6.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 6.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclospo

Current exclusion criteria as of 16/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides 5. Exclusion criteria related to azithromycin: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known myasthenia gravis 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions _____ Previous exclusion criteria as of 08/06/2020: 1. Patient currently admitted in hospital 2. Almost recovered (generally much improved and symptoms now mild or almost absent) 3. Judgement of the recruiting clinician deems ineligible 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm. 5. Exclusion criteria related to hydroxychloroquine: 5.1. Pregnancy 5.2. Breastfeeding 5.3. Known severe hepatic impairment 5.4. Known severe renal impairment 5.5. Known porphyria 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus 5.6. Known G6PD deficiency 5.7. Known myasthenia gravis 5.8. Known severe psoriasis 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold) 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolides 5.12. Known congenital or documented QT prolongation 5.13. Known retinal disease 6. Exclusion criteria related to azithromycin: 6.1. Pregnancy 6.2. Breastfeeding 6.3. Known severe hepatic impairment 6.4. Known severe renal impairment 6.5. Known myasthenia gravis 6.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides 6.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclospo