Created at Source Raw Value Validated value
Nov. 10, 2020, 12:30 a.m. eu

Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19). 2. Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. 3. A score of Grade 3 to 5 on the 9-point ordinal scale. 4. a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 90 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for a fixed period of time (following guidance that will be given by the investigator as appropriate for any candidate agent administered) after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). 6. Ability to provide informed consent signed by the study patient or legally authorised representative. In addition for the sub-protocol ACCORD-2-006: Antibiotic prophylaxis: PLEASE NOTE that, according to Protocol Section 4.1.1.1, all patients must take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan. For the sub-protocol ACCORD-2-002: Inclusion criteria 4 and 5 will be modified from the Master Protocol, as the contraception requirements will need to be for 120 days (not 90 days) after termination of study therapy, and breastfeeding restrictions will be for a similar time period. The revised criteria will be as follows: 4.a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5 of the Master Protocol), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the Master Protocol. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).

Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19). 2. Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. 3. A score of Grade 3 to 5 on the 9-point ordinal scale. 4. a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 90 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for a fixed period of time (following guidance that will be given by the investigator as appropriate for any candidate agent administered) after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). 6. Ability to provide informed consent signed by the study patient or legally authorised representative. In addition for the sub-protocol ACCORD-2-006: Antibiotic prophylaxis: PLEASE NOTE that, according to Protocol Section 4.1.1.1, all patients must take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan. For the sub-protocol ACCORD-2-002: Inclusion criteria 4 and 5 will be modified from the Master Protocol, as the contraception requirements will need to be for 120 days (not 90 days) after termination of study therapy, and breastfeeding restrictions will be for a similar time period. The revised criteria will be as follows: 4.a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5 of the Master Protocol), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the Master Protocol. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).

Oct. 26, 2020, 7:26 a.m. eu

Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19). 2. Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. 3. A score of Grade 3 to 5 on the 9-point ordinal scale. 4. a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 90 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for a fixed period of time (following guidance that will be given by the investigator as appropriate CONFIDENTIAL ACCORD-2-001 – Master Protocol (Amendment 02) Final, 02 June 2020 32 for any candidate agent administered) after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). 6. Ability to provide informed consent signed by the study patient or legally authorized representative. In addition for the sub-protocol ACCORD-2-003: a) Male subjects A male subject must agree to use contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 12 weeks after the last dose of study treatment and refrain from donating sperm during this period. b) Female subjects A female subject is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 12 weeks after the last dose of study treatment In addition for the sub-protocol ACCORD-2-004: Male subjects: A male subject must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 12 weeks after the last dose of study treatment and refrain from donating sperm during this period. A female subject is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 weeks after the last dose of study treatment. In addition for the sub-protocol ACCORD-2-006: Antibiotic prophylaxis: PLEASE NOTE that, according to Section 4.1.1.1, all patients must take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan. For Sub study ACCORD 2-005, please refer to the Master protocol. For Sub study ACCORD 2-008, please refer to the Master protocol.

Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19). 2. Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. 3. A score of Grade 3 to 5 on the 9-point ordinal scale. 4. a) Male patients: A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. b) Female patients: A female patient is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 90 days after the last dose of study treatment. 5. Women who are lactating who agree not to breastfeed their child during the study and for a fixed period of time (following guidance that will be given by the investigator as appropriate CONFIDENTIAL ACCORD-2-001 – Master Protocol (Amendment 02) Final, 02 June 2020 32 for any candidate agent administered) after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). 6. Ability to provide informed consent signed by the study patient or legally authorized representative. In addition for the sub-protocol ACCORD-2-003: a) Male subjects A male subject must agree to use contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 12 weeks after the last dose of study treatment and refrain from donating sperm during this period. b) Female subjects A female subject is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 12 weeks after the last dose of study treatment In addition for the sub-protocol ACCORD-2-004: Male subjects: A male subject must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 12 weeks after the last dose of study treatment and refrain from donating sperm during this period. A female subject is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 weeks after the last dose of study treatment. In addition for the sub-protocol ACCORD-2-006: Antibiotic prophylaxis: PLEASE NOTE that, according to Section 4.1.1.1, all patients must take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan. For Sub study ACCORD 2-005, please refer to the Master protocol. For Sub study ACCORD 2-008, please refer to the Master protocol.