Created at Source Raw Value Validated value
Dec. 10, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Randomized open clinical trial with the inclusion of 400 health professionals in direct contact with patients suspected of COVID-19. Two hundred individuals will be randomly allocated to each group. The vaccinated group will receive a dose of BCG vaccine and will be followed for 7; 15; 30; 60; and 180 days by telemedicine for signs and symptoms of COVID-19 or possible adverse signs of the BCG vaccine. Fifteen days after randomization; blood will be collected to repeat the COVID-19 test and to assess the immune response. Anyone who tested positive for COVID-19 at this stage will be excluded. At any time when COVID-19 is suspected; blood will be collected for further examination and the participant will be referred for nasal swab collection for RT-PCR for COVID-19. At the end of the study; all individuals who did not show signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.The control group will not be vaccinated. Individuals in this group will be followed up at 7; 15; 30; 60; and 180 days after intervention or when necessary for signs and symptoms of COVID-19. Fifteen days after randomization; blood will be collected for examination of COVID-19 and to assess the immune response. All participants who are positive for COVID-19 will be excluded. At the end of the study; everyone who did not show any signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.At the end; the results will be compared between the control and BCG vaccinated groups according to the outcomes: signs and symptoms of COVID-19; worsening; hospitalization.For the secondary outcome; the innate immune response elicited 15-20 days after vaccination will;D20.215.894.135.825.100", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

Oct. 7, 2021, 9:30 a.m. oms

[]

Dec. 15, 2020, 2:47 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Randomized open clinical trial with the inclusion of 400 health professionals in direct contact with patients suspected of COVID-19. Two hundred individuals will be randomly allocated to each group. The vaccinated group will receive a dose of BCG vaccine and will be followed for 7; 15; 30; 60; and 180 days by telemedicine for signs and symptoms of COVID-19 or possible adverse signs of the BCG vaccine. Fifteen days after randomization; blood will be collected to repeat the COVID-19 test and to assess the immune response. Anyone who tested positive for COVID-19 at this stage will be excluded. At any time when COVID-19 is suspected; blood will be collected for further examination and the participant will be referred for nasal swab collection for RT-PCR for COVID-19. At the end of the study; all individuals who did not show signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.The control group will not be vaccinated. Individuals in this group will be followed up at 7; 15; 30; 60; and 180 days after intervention or when necessary for signs and symptoms of COVID-19. Fifteen days after randomization; blood will be collected for examination of COVID-19 and to assess the immune response. All participants who are positive for COVID-19 will be excluded. At the end of the study; everyone who did not show any signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.At the end; the results will be compared between the control and BCG vaccinated groups according to the outcomes: signs and symptoms of COVID-19; worsening; hospitalization.For the secondary outcome; the innate immune response elicited 15-20 days after vaccination will;Biological/vaccine;D20.215.894.135.825.100", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Nov. 6, 2020, 11:45 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Randomized open clinical trial with the inclusion of 400 health professionals in direct contact with patients suspected of COVID-19. Two hundred individuals will be randomly allocated to each group. The vaccinated group will receive a dose of BCG vaccine and will be followed for 7; 15; 30; 60; and 180 days by telemedicine for signs and symptoms of COVID-19 or possible adverse signs of the BCG vaccine. Fifteen days after randomization; blood will be collected to repeat the COVID-19 test and to assess the immune response. Anyone who tested positive for COVID-19 at this stage will be excluded. At any time when COVID-19 is suspected; blood will be collected for further examination and the participant will be referred for nasal swab collection for RT-PCR for COVID-19. At the end of the study; all individuals who did not show signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.The control group will not be vaccinated. Individuals in this group will be followed up at 7; 15; 30; 60; and 180 days after intervention or when necessary for signs and symptoms of COVID-19. Fifteen days after randomization; blood will be collected for examination of COVID-19 and to assess the immune response. All participants who are positive for COVID-19 will be excluded. At the end of the study; everyone who did not show any signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.At the end; the results will be compared between the control and BCG vaccinated groups according to the outcomes: signs and symptoms of COVID-19; worsening; hospitalization.For the secondary outcome; the innate immune response elicited 15-20 days after vaccination will;Biological/vaccine;Need for immunization against certain single viral diseases ;BCG Vaccine", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Randomized open clinical trial with the inclusion of 400 health professionals in direct contact with patients suspected of COVID-19. Two hundred individuals will be allocated to each group in a randomized manner. The vaccinated group will receive a dose of BCG vaccine and will be followed for 7; 15; 30; 60; and 180 days after the telemedicine intervention for signs and symptoms of COVID-19 or possible adverse signs of the BCG vaccine. Fifteen days after vaccination; blood will be collected to assess the immune response induced by the vaccine. At any time when COVID-19 is suspected; blood will be collected for further examination and the participant will be referred for nasal swab collection for RTPCR for COVID-19. At the end of 1 year of inclusion in the study; everyone who did not show any signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.The control group will not be vaccinated. Individuals in this group will be followed up at 7; 15; 30; 60; and 180 days after intervention or when necessary for signs and symptoms of COVID-19. At the end of 1 year of inclusion in the study; everyone who did not show any signs or symptoms of COVID-19 during follow-up will be contacted for final blood collection for antibodies against SARS-Cov2.In the end the group vaccine and control will be compared according the COVID-19 outcomes.;Biological/vaccine;Need for immunization against certain single viral diseases ;BCG Vaccine", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]