Name (Synonyms) | Correlation | |
---|---|---|
drug1365 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 1.00 |
drug1569 | Liberase Enzyme (Roche) Wiki | 1.00 |
drug631 | Centricyte 1000 Wiki | 1.00 |
drug1746 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 1.00 |
drug2743 | Sterile Normal Saline for Intravenous Use Wiki | 1.00 |
drug1598 | Lopinavir/ Ritonavir Wiki | 1.00 |
drug1095 | Favipiravir Placebo Wiki | 0.71 |
drug1087 | Favipiravir Wiki | 0.23 |
Name (Synonyms) | Correlation | |
---|---|---|
D011649 | Pulmonary Alveolar Proteinosis NIH | 1.00 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 1.00 |
D011658 | Pulmonary Fibrosis NIH | 0.38 |
D017563 | Lung Diseases, Interstitial NIH | 0.29 |
D008171 | Lung Diseases, NIH | 0.24 |
D011024 | Pneumonia, Viral NIH | 0.12 |
D003141 | Communicable Diseases NIH | 0.08 |
D007239 | Infection NIH | 0.05 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0006517 | Intraalveolar phospholipid accumulation HPO | 1.00 |
HP:0002206 | Pulmonary fibrosis HPO | 0.38 |
HP:0006515 | Interstitial pneumonitis HPO | 0.29 |
HP:0002088 | Abnormal lung morphology HPO | 0.24 |
There is one clinical trial.
The current pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The trial will be conducted in key workers who are at high risk of acquiring SARS-CoV-2 infection and their household members. Apart from the risk of severe illness and death in the workers themselves and their household members, this phenomenon also impacts health system staffing levels. The objective of the FLARE trial is to assess whether early antiviral therapy with either favipiravir + Lopinavir/ritonavir (LPV/r), LPV/r or favipiravir is associated with a decrease in viral load compared with placebo.The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.
Description: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
Measure: Upper respiratory tract viral load at Day 5 Time: Day 5 from randomisationDescription: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
Measure: Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy Time: 5 days from randomisationDescription: Quantitative polymerase chain reaction (PCR) performed on stool samples at Day 7 and Day 14 post-randomisation
Measure: Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: PCR performed on daily saliva samples collected between Day 1 and Day 7 post-randomisation
Measure: Rate of decrease in upper respiratory tract viral load during 7 days of therapy Time: 7 daysDescription: Daily body temperature records between Day 1 and Day 7 post-randomisation
Measure: Duration of fever following commencement of medication Time: 7 daysDescription: Standard diagnostic laboratory assays for liver transaminases, alkaline phosphatase and bilirubin
Measure: Proportion of participants with hepatotoxicity after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: Determination of medication-related adverse events by investigators at Day 7 and Day 14 post-randomisation
Measure: Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants admitted to hospital with COVID-19 related illness Time: 28 daysDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants admitted to ICU with COVID-19 related illness Time: 28 daysDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants who have died with COVID-19 related illness Time: 28 daysDescription: Assess pharmacokinetics of favipiravir as measured by Clearance (CL)
Measure: Pharmacokinetics of favipiravir as measured by Clearance (CL) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Volume of distribution (V)
Measure: Pharmacokinetics of favipiravir as measured by Volume of distribution (V) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka)
Measure: Pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax)
Measure: Pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax)
Measure: Pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke)
Measure: Pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf)
Measure: Pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta)
Measure: Pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax)
Measure: Pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50)
Measure: Pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50) Time: Day 7 from randomisationDescription: Deep sequencing of virus and bioinformatic analysis
Measure: Proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2 by Day 7 of treatment Time: Day 7 from randomisation