Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Recipient Inclusion Criteria: <br/ > <br/ >- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ > <br/ >Patients on ventilator (in last 24 hours) <br/ >Respiratory distress, RR greater than or equal to 30 beats/min <br/ >Oxygen saturation level less than 90 % in resting state <br/ >Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ >Lung infiltrates > 50% within 24 to 48 hours <br/ >Donor Inclusion Criteria for Plasmapheresis <br/ > <br/ >Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ >Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ >Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.

Recipient Inclusion Criteria: <br/ > <br/ >- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ > <br/ >Patients on ventilator (in last 24 hours) <br/ >Respiratory distress, RR greater than or equal to 30 beats/min <br/ >Oxygen saturation level less than 90 % in resting state <br/ >Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ >Lung infiltrates > 50% within 24 to 48 hours <br/ >Donor Inclusion Criteria for Plasmapheresis <br/ > <br/ >Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ >Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ >Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.

Nov. 13, 2021, 5:33 p.m. oms

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

Recipient Inclusion Criteria: <br/ > <br/ >- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ > <br/ >Patients on ventilator (in last 24 hours) <br/ >Respiratory distress, RR greater than or equal to 30 beats/min <br/ >Oxygen saturation level less than 90 % in resting state <br/ >Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ >Lung infiltrates > 50% within 24 to 48 hours <br/ >Donor Inclusion Criteria for Plasmapheresis <br/ > <br/ >Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ >Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ >Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.

Recipient Inclusion Criteria: <br/ > <br/ >- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ > <br/ >Patients on ventilator (in last 24 hours) <br/ >Respiratory distress, RR greater than or equal to 30 beats/min <br/ >Oxygen saturation level less than 90 % in resting state <br/ >Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ >Lung infiltrates > 50% within 24 to 48 hours <br/ >Donor Inclusion Criteria for Plasmapheresis <br/ > <br/ >Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ >Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ >Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.