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Name (Synonyms) | Correlation | |
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drug2945 | SARS-CoV2 Infection Wiki | 0.58 |
drug14 | 0.9% Saline Wiki | 0.41 |
drug16 | 0.9% saline Wiki | 0.33 |
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There are 3 clinical trials
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic. To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Description: To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of TY027 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of TY027 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of TY027.
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of TY027.
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of TY027 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of TY027 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of TY027 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 84 DaysThe emergence & rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation on 11 March 2020. To date, tens of millions of cases have been reported and over 3% of these cases have died. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets/close contact. Fomite transmission has also been shown as a transmission route. Common respiratory symptoms such as fever, sore throat, cough & shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality rate. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed to treat disease & reduce further transmission in order to disrupt the ongoing pandemic. To date, there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients. Supportive care is recommended for symptom relief & for severe cases. Numerous vaccine candidates against SARS-CoV-2 are under development. Tychan's TY027, a fully engineered human IgG, is one of the first few biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. Preliminary data from our phase 1 healthy volunteer trial (SCT-001; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe & well-tolerated up to 20 mg/kg tested. A total of 10 adverse events (AEs) were observed, all were of mild in intensity with none resulting in subject withdrawal from the study. There were no serious adverse events & no clinically relevant trends in mean clinical laboratory, physical examinations, vital signs or ECG results were observed. Pharmacokinetic profile of subjects across dose cohorts 1 - 4, up to Day 14, were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner. Exposure of TY027, based on Cmax, increased in a linear & generally dose proportional manner. It is anticipated that TY027, when administered to acutely infected COVID-19 patients, could reduce disease severity. It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts.
Description: Proportion of COVID-19 patients with disease progression, defined as progression to score 4 and below on the COVID Scale, within the first 14 days after a single dose IV infusion of TY027 as compared to placebo
Measure: To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale Time: Within the first 14 daysDescription: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients after a single dose IV infusion of TY027 as compared to placebo
Measure: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients Time: 28 daysDescription: All cause mortality rate by Day 28 in COVID-19 patients who receive a single dose IV infusion of TY027 as compared to placebo
Measure: All cause mortality rate Time: 28 daysDescription: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale at Day 7, Day 14 and Day 28
Measure: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale Time: Up to Day 28Description: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) after a single dose IV infusion of TY027 as compared to placebo up to Day 28
Measure: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) Time: 28 daysDescription: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 3, Day 5, Day 7, Day 14 and Day 28 after a single dose IV infusion of TY027 as compared to placebo
Measure: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) Time: Up to Day 28Description: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR, at Day 7 post-dose or day of discharge, whichever is earlier, as compared to baseline between study groups
Measure: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR Time: Day 7 post-dose or day of discharge, whichever is earlierThe emergence & rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation on 11 March 2020. To date, tens of millions of cases have been reported and over 3% of these cases have died. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets/close contact. Fomite transmission has also been shown as a transmission route. Common respiratory symptoms such as fever, sore throat, cough & shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality rate. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed to treat disease & reduce further transmission in order to disrupt the ongoing pandemic. To date, there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients. Supportive care is recommended for symptom relief & for severe cases. Numerous vaccine candidates against SARS-CoV-2 are under development. Tychan's TY027, a fully engineered human IgG, is one of the first few biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. Preliminary data from our phase 1 healthy volunteer trial (SCT-001; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe & well-tolerated up to 20 mg/kg tested. A total of 10 adverse events (AEs) were observed, all were of mild in intensity with none resulting in subject withdrawal from the study. There were no serious adverse events & no clinically relevant trends in mean clinical laboratory, physical examinations, vital signs or ECG results were observed. Pharmacokinetic profile of subjects across dose cohorts 1 - 4, up to Day 14, were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner. Exposure of TY027, based on Cmax, increased in a linear & generally dose proportional manner. It is anticipated that TY027, when administered to acutely infected COVID-19 patients, could reduce disease severity. It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts.
Description: Proportion of COVID-19 patients with disease progression, defined as progression to score 4 and below on the COVID Scale, within the first 14 days after a single dose IV infusion of TY027 as compared to placebo
Measure: To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale Time: Within the first 14 daysDescription: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients after a single dose IV infusion of TY027 as compared to placebo
Measure: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients Time: 28 daysDescription: All cause mortality rate by Day 28 in COVID-19 patients who receive a single dose IV infusion of TY027 as compared to placebo
Measure: All cause mortality rate Time: 28 daysDescription: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale at Day 7, Day 14 and Day 28
Measure: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale Time: Up to Day 28Description: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) after a single dose IV infusion of TY027 as compared to placebo up to Day 28
Measure: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) Time: 28 daysDescription: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 3, Day 5, Day 7, Day 14 and Day 28 after a single dose IV infusion of TY027 as compared to placebo
Measure: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) Time: Up to Day 28Description: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR, at Day 7 post-dose or day of discharge, whichever is earlier, as compared to baseline between study groups
Measure: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR Time: Day 7 post-dose or day of discharge, whichever is earlierAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports