Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; 2. behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; 3. any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; 4. severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; 5. to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; 6. the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; 7. any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: 8. pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: 9. previous immunization with vaccine against covid-19

1. presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; 2. behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; 3. any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; 4. severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; 5. to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; 6. the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; 7. any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: 8. pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: 9. previous immunization with vaccine against covid-19

Nov. 16, 2021, 6:30 p.m. usa

presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: previous immunization with vaccine against covid-19

presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: previous immunization with vaccine against covid-19

April 9, 2021, 12:31 a.m. usa

1. presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; 2. behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; 3. any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; 4. severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; 5. to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; 6. the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; 7. any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: 8. pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: 9. previous immunization with vaccine against covid-19

1. presenting covid-9 in need of oxygen therapy on the moment of study inclusion, in other words, score 5 or higher in who covid-19 progression scale; 2. behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; 3. any use considered alcohol or drugs abuse in the last 12 months prior to study inclusion that caused medical, professional or family problems, as indicated by clinical history; 4. severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; 5. to have received heterologous serum or convalescent plasma in the last three months before of study inclusion, or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; 6. the participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. dependency relationships include close relatives (in other words, sons, partner/spouse, brothers, parents), as well as researcher staff or staff from the location conducting the study; 7. any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. for female: 8. pregnancy (confirmed by positive β-hcg test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; for stages a and b: 9. previous immunization with vaccine against covid-19