Name (Synonyms) | Correlation | |
---|---|---|
drug1183 | Treatment with Dexmedetomidine Wiki | 1.00 |
drug647 | Lopinavir/ritonavir Wiki | 0.30 |
drug505 | Hydroxychloroquine Wiki | 0.11 |
Name (Synonyms) | Correlation | |
---|---|---|
D003141 | Communicable Diseases NIH | 0.11 |
D007239 | Infection NIH | 0.07 |
Name (Synonyms) | Correlation |
---|
There is one clinical trial.
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization. Subjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19. Participants will be randomized to one of the following groups: 1. Lopinavir/ritonavir 400mg/100mg PO BID for 14 day plus optimized supportive care, OR 2. Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care, OR 3. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR 4. Optimized support care all or until discharge from hospital, whichever occurs first
Description: All-cause mortality, assessed at hospital discharge.
Measure: Efficacy of Interventions as assessed by all-cause mortality Time: 29 daysDescription: Measure with Ordinal Scale the time it takes for subject improvement
Measure: Time to improvement of one category from admission Time: up to 60 daysDescription: Subject clinical status at days 3, 5, 8, 11, 15, 29, 60 measured using the ordinal scale below: The scale is as below 0: Uninfected, no viral RNA Asymptomatic, viral RNA detected Symptomatic, independent Symptomatic, Assistance Needed Hospitalized: no oxygen therapy Hospitalized, on oxygen Hospitalized, Oxygen by NIV or high-flow Mechanical ventilation, p/f>150 or s/f >200 Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO death
Measure: Subject clinical status Time: up to 60 daysDescription: Mean change in the ranking from baseline to days 3, 5, 8, 11, 15, 29, 60 using the ordinal scale below: The scale is as below 0: Uninfected, no viral RNA Asymptomatic, viral RNA detected Symptomatic, independent Symptomatic, Assistance Needed Hospitalized: no oxygen therapy Hospitalized, on oxygen Hospitalized, Oxygen by NIV or high-flow Mechanical ventilation, p/f>150 or s/f >200 Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO death
Measure: Change in Subject clinical status Time: up to 60 daysDescription: the number of oxygen free days experienced
Measure: Oxygen free days Time: up to 29 daysDescription: if the subject required oxygen during hospitalization
Measure: Incidence of oxygen use Time: up to 29 daysDescription: if the subject required oxygen, for how long was it required
Measure: Duration of oxygen use Time: up to 29 daysDescription: if the subject required mechanical ventilation during hospitalization
Measure: Incidence of new mechanical ventilation Time: up to 29 daysDescription: if the subject required mechanical ventilation, for how long was it required
Measure: Duration of mechanical ventilation Time: up to 29 daysDescription: the length of hospitalization required
Measure: Duration of hospitalization Time: up to 29 daysDescription: Mortality rates calculated at day 15, 29, and 60.
Measure: Mortality Time: up to 60 daysDescription: The safety of the intervention will be evaluated during the trial period as compared to the control arm as assessed by the cumulative incidence of Grade 3 and 4 AEs and SAEs using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, version 2.1 (July 2017).
Measure: Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: up to 30 days after last dose of drug adminstrationDescription: To evaluate the virologic efficacy of lopinavir/ritonavir, hydroxychloroquine, or remdesivir as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP sample at days 3, 5, 8, 11, 15, and 29
Measure: Time to viral clearance of lopinavir/ritonavir as compared to the control arm Time: up to 29 days