Covid 19 Clinical Trials

Current standard of care (SOC) for the management of hospitalized COVID-19 cases differs in various North American hospitals, particularly in the pharmacological treatments used, and is constantly changing. At the moment, available options (depending on the hospital's treatment protocol, the physician's medical judgment, contraindications, and disease presentation) include hydroxychloroquine, chloroquine, remdesivir, ceftriaxone, azithromycin, piperacillin-tazobactam, lopinavir-ritonavir, and IL-6 receptor antagonists. In most hospital treatment protocols, the use of the latter is generally to be considered in patients with evidence of cytokine release syndrome and elevated IL-6, on a case-by-case basis. Adults who suffer major COVID-19 complications appear to present a major inflammatory storm. Therefore, targeting the inflammatory response may reduce COVID-19-related complications in adults at risk or with evidence of an inflammatory storm. EB05 is a potent inhibitor of TLR4, a key component of the innate immune system which functions to detect molecules generated by pathogens, acting upstream of cytokine storm and IL-6-mediated acute lung injury. EB05 has demonstrated safety in two clinical studies (>165 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Furthermore, TLR4 blockade rescued mice from lethal influenza-induced Acute Respiratory Distress Syndrome (ARDS), a major cause of mortality associated with COVID-19, thus could be useful in the management of COVID-19. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality.

NCT04401475 COVID-19 ARDS Biological: SOC plus 15mg/kg EB05 IV Other: SOC plus Placebo IV

Primary Outcomes

Description: The severity of COVID-19 related respiratory disease is assessed on the following seven-point ordinal scale: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, requiring Extracorporeal Membrane Oxygenation (ECMO), invasive mechanical ventilation, or both, and; death. For the current study the primary efficacy outcome measure will be the proportion of patients with clinical improvement at 28 days of follow-up, defined as an improvement of two points on the seven-point ordinal scale.

Measure: An improvement of two points on the seven-point ordinal scale

Time: 28 days

Secondary Outcomes

Description: Time to clinical improvement by 2 points on the seven-point ordinal scale described in primary outcome.

Measure: Time to clinical improvement by 2 points on the seven-point ordinal scale described in primary outcome.

Time: 28 days

Description: Ventilator-free days.

Measure: Ventilator-free days.

Time: 28 days

Description: Duration of ventilation

Measure: Duration of ventilation

Time: 28 days

Description: Mortality rate

Measure: Mortality rate

Time: 28 days

Description: Duration of hospitalization

Measure: Duration of hospitalization

Time: 28 days

Description: Time to independence from supplementary oxygen therapy

Measure: Time to independence from supplementary oxygen therapy

Time: 28 days

Description: Time to normalization of oxygen saturation, defined as Sp02 > 94% sustained minimum 24 hours

Measure: Time to normalization of oxygen saturation, defined as Sp02 > 94% sustained minimum 24 hours

Time: 24 hours

Description: Change in four-point Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized

Measure: Change in four-point Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized

Time: 28 days

Description: Radiological response to treatment based on Thoracic Computerized Tomography Scan (CT-Scan) or Chest X-Ray

Measure: Radiological response to treatment based on Thoracic Computerized Tomography Scan (CT-Scan) or Chest X-Ray

Time: 28 days

Description: Change in cytokines, including IL-6, and C-reactive protein (CRP) levels

Measure: Change in cytokines, including IL-6, and C-reactive protein (CRP) levels

Time: 28 days

Description: Defined as post-baseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary).

Measure: Time to resolution of fever for at least 48 hours without antipyretics

Time: 28 days

Description: Decision by the attending physician to initiate treatment with another targeted immunomodulator (i.e. IL-6 inhibitors)

Measure: Decision by the attending physician to initiate treatment with another targeted immunomodulator (i.e. IL-6 inhibitors)

Time: 28 days

Description: Change in the four-point Berlin ARDS severity scale

Measure: Change in the four-point Berlin ARDS severity scale

Time: 28 days

Description: Change in three-point Acute Kidney Injury Network (AKIN) classification

Measure: Change in three-point Acute Kidney Injury Network (AKIN) classification

Time: 28 days

Description: Change in troponin levels

Measure: Change in troponin levels

Time: 28 days

Other Outcomes

Description: Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.

Measure: Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.

Time: 28 days

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (2)

Correlated MeSH Terms (3)

Correlated HPO Terms (1)

Clinical Trials

1 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With Moderate to Severe COVID-19

NCT04401475 COVID-19 ARDS Biological: SOC plus 15mg/kg EB05 IV Other: SOC plus Placebo IV

Primary Outcomes

Secondary Outcomes

Other Outcomes

No related HPO nodes (Using clinical trials)