Name (Synonyms) | Correlation | |
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drug805 | Suspension of heat killed (autoclaved) Mycobacterium w Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D009164 | Mycobacterium Infections NIH | 0.58 |
D016638 | Critical Illness NIH | 0.26 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day of transfer from ICU, if earlier than 28 days.Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day of transfer from ICU, if earlier than 28 days.Description: All-cause mortality
Measure: All-cause mortality Time: Till day 28Description: Any AE / SAE or event of clinical significance observed during the study.
Measure: Incidence of AE / SAE or event of clinical significance Time: Till day 28Description: Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
Measure: SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample Time: At days 3, 7, 14, 21, and 28Description: ICU length of stay
Measure: ICU length of stay Time: Till day 28Description: Duration of mechanical ventilation
Measure: Duration of mechanical ventilation Time: Till day 28Description: Duration of hospitalization
Measure: Duration of hospitalization Time: Till day 28Description: Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
Measure: Clinical improvement Time: From base line at day 14 & Day 28Description: Time (in days) from treatment initiation to death.
Measure: Time (in days) from treatment initiation to death Time: Till day 28