CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


TD139Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug1566 Nafamostat Mesilate Wiki 0.71
drug2314 Standard care Wiki 0.38
drug1372 Lopinavir/ritonavir Wiki 0.32

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Rapid Experimental Medicine for COVID-19 - DEFINE COVID-19

COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.

NCT04473053 COVID-19 Drug: Nafamostat Mesilate Drug: TD139 Other: Standard care

Primary Outcomes

Description: Measure vital signs (blood pressure/heart rate/temperature and respiratory rate)

Measure: The safety of the candidate therapies in COVID-19 patients by measuring physiological changes in the circulatory and respiratory system.

Time: Up to 16 days post treatment

Description: Record number of participants With treatment-related adverse events

Measure: The safety of the candidate therapies in COVID-19 patients by recording the number of treatment related adverse events.

Time: Up to 90 days post treatment

Secondary Outcomes

Description: Measure maximum plasma concentration [Cmax] in blood samples.

Measure: Measuring the PK of the proposed trial treatments in COVID-19 patients.

Time: 6 months

Description: Change in expression or activity of coagulation markers in serial blood samples taken before, during and after treatment.

Measure: Measure a change in the expression of key coagulation biomarkers in the blood of COVID-19 patients during and after treatment period.

Time: 6 months

Description: Change in expression or activity of inflammatory cytokines in serial blood samples taken before, during and after treatment.

Measure: Measure a change in the expression of key cytokines in the blood of COVID-19 patients during and after treatment period.

Time: 6 months

Description: Record changes in National Early Warning Score (NEWS) 2 score. Scale is from 0-20, with a higher number indicating a higher risk of morbidity.

Measure: To evaluate the improvement or deteroriation of patients in each treatment arm.

Time: 16 days

Description: Duration (days) of oxygen use

Measure: To evaluate the number of oxygen-free days.

Time: 16 days

Description: Duration (days) of ventilation

Measure: To evaluate incidence of any form of new ventilation use.

Time: 16 days

Description: Duration of ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use.

Measure: To evaluate ventilator-free days

Time: 16 days

Description: SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death

Measure: Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2)

Time: 16 days

Description: Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal/saliva swab while hospitalised on Days 1, 3, 5, 8, 11, 15.

Measure: To evaluate SARS-CoV-2 viral load.

Time: 15 days

Description: Duration of total hospital stay • Duration to discharge following treatment

Measure: To evaluate time to discharge

Time: 16 days

Description: Record requirement for renal dialysis or haemofiltration

Measure: To evaluate the use of renal dialysis or haemofiltration for each treatment arm.

Time: 16 days


No related HPO nodes (Using clinical trials)