CovidResearchTrials by Shray Alag

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remdesivirWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1063 High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki 1.00
drug2308 Standard Plasma (FFP) Wiki 1.00
drug1372 Lopinavir/ritonavir Wiki 0.32
drug1086 Hydroxychloroquine Wiki 0.10

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.09
D007239 Infection NIH 0.06

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)

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

NCT04330690 COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: remdesivir

Primary Outcomes

Description: All-cause mortality, assessed at hospital discharge.

Measure: Efficacy of Interventions as assessed by all-cause mortality

Time: 29 days

Secondary Outcomes

Description: Measure with Ordinal Scale the time it takes for subject improvement

Measure: Time to improvement of one category from admission

Time: up to 60 days

Description: 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 days

Description: 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 days

Description: the number of oxygen free days experienced

Measure: Oxygen free days

Time: up to 29 days

Description: if the subject required oxygen during hospitalization

Measure: Incidence of oxygen use

Time: up to 29 days

Description: if the subject required oxygen, for how long was it required

Measure: Duration of oxygen use

Time: up to 29 days

Description: if the subject required mechanical ventilation during hospitalization

Measure: Incidence of new mechanical ventilation

Time: up to 29 days

Description: if the subject required mechanical ventilation, for how long was it required

Measure: Duration of mechanical ventilation

Time: up to 29 days

Description: the length of hospitalization required

Measure: Duration of hospitalization

Time: up to 29 days

Description: Mortality rates calculated at day 15, 29, and 60.

Measure: Mortality

Time: up to 60 days

Description: 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 adminstration

Other Outcomes

Description: 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

No related HPO nodes (Using clinical trials)