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MRx-4DP0004Wiki

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


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug184 ChAdOx1 MERS Wiki 0.71
drug616 Placebo Wiki 0.10

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.15
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)

This is a randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of MRx-4DP0004 in patients with COVID-19. 90 hospitalised patients will be enrolled and randomised (2:1) to receive MRx-4DP0004 or placebo for up to 14 days. MRx-4DP0004 is an immunomodulating Live Biotherapeutic Product (LBP) which is expected to prevent or reduce the hyperinflammatory response to SARS-CoV-2 infection without impairing viral clearance.

NCT04363372 COVID-19 Drug: MRx-4DP0004 Drug: Placebo

Primary Outcomes

Description: Clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement where patients are scored on a scale of 0-8 with 0 being uninfected and 8 being dead

Measure: Change in mean clinical status score in each treatment arm

Time: Baseline to Day 42

Secondary Outcomes

Description: Safety and tolerability will be determined according to clinically relevant reported adverse events

Measure: Number of adverse events in each treatment arm

Time: Baseline to Day 42

Description: Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

Measure: Number of patients with an improvement in clinical status score in each treatment arm

Time: Day 1 to Day 42

Description: Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

Measure: Number of patients with a deterioration in clinical status score in each treatment arm

Time: Day 1 to Day 42

Description: Oxygen saturation will be measured as per local standard procedures

Measure: Number of patients with at least 95% oxygen saturation on room air in each treatment arm

Time: Day 1 to Day 14

Description: Oxygen saturation will be recorded daily during hospitalisation to determine the mean time for each arm to reach at least 95% saturation

Measure: Time to patients with at least 95% oxygen saturation on room air in each treatment arm

Time: Day 1 to Day 14

Description: The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature

Measure: Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm

Time: Day 1 to Day 14

Description: The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature

Measure: Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm

Time: Day 1 to Day 14

Description: Details of required respiratory support will be recorded throughout hospitalisation

Measure: Number of patients requiring Continuous Positive Airway Pressure in each treatment arm

Time: Day 1 to Day 14

Description: Details of required respiratory support will be recorded throughout the treatment period

Measure: Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm

Time: Day 1 to Day 14

Description: Details of required respiratory support will be recorded throughout the treatment period

Measure: Time to patients requiring Continuous Positive Airway Pressure in each treatment arm

Time: Day 1 to Day 14

Description: Details of required respiratory support will be recorded throughout the treatment period

Measure: Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm

Time: Day 1 to Day 14

Description: Length of hospital stay will be compared

Measure: Time to discharge in each treatment arm

Time: Day 1 to Day 42

Description: All cause mortality will be compared

Measure: Number of deaths in each treatment arm

Time: Day 1 to Day 42

No related HPO nodes (Using clinical trials)