Created at Source Raw Value Validated value
Feb. 12, 2021, 1:30 a.m. eu

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO) 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Exclusion criterion 7 removed per Amendment 10 8. Exclusion Criterion 8 removed per Amendment 10

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO) 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Exclusion criterion 7 removed per Amendment 10 8. Exclusion Criterion 8 removed per Amendment 10

Dec. 15, 2020, 1:30 a.m. eu

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow-Oxygen* 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Exclusion criterion 7 removed per Amendment 10 8. Exclusion Criterion 8 removed per Amendment 10

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow-Oxygen* 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Exclusion criterion 7 removed per Amendment 10 8. Exclusion Criterion 8 removed per Amendment 10

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

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow-Oxygen* 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Renal disease requiring dialysis, or known renal insufficiency (eGFR≤30 mL/min/1.73 m2, based on Cockroft & Gault formula) 8. In France: o Non-affiliation to compulsory French social security scheme (beneficiary or right-holder) o Being under tutelage or legal guardianship * High-flow oxygen is defined as deliverey of oxygen at a flow ≥of 16L/min

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow-Oxygen* 4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 7. Renal disease requiring dialysis, or known renal insufficiency (eGFR≤30 mL/min/1.73 m2, based on Cockroft & Gault formula) 8. In France: o Non-affiliation to compulsory French social security scheme (beneficiary or right-holder) o Being under tutelage or legal guardianship * High-flow oxygen is defined as deliverey of oxygen at a flow ≥of 16L/min