Covid 19 Clinical Trials

Some patients infected with COVID-19 require hospitalisation and develop patients a severe form of a lung disease called respiratory distress syndrome (ARDS). In these patients, the lungs become severely inflamed because of the virus. The inflammation causes fluid from nearby blood vessels to leak into the tiny air sacs in the lungs, making breathing increasingly difficult. This fluid forms small clots in the air sacs, creating a barrier until the cells regenerate. In some patients, this clot does not disappear in a timely fashion or interferes with the development of the new cells. Furthermore, the small clots in the air sacs obstruct the air and oxygen getting deep into the lungs, interfering with proper ventilation. The trial will recruit patients with COVID-19 induced ARDS. Eligible patients (or if patients lack capacity, their legal representative) will be provided with an information sheet and informed consent will be sought. Eligibility will be mainly assessed via routine clinical assessments. Patients will receive a nebulised version of a type of drug called tissue plasminogen activator (rt-PA) that is inhaled using a nebuliser. This is normally a drug used to break down blood clots. In this situation though, it might be useful for stopping clots forming in the lungs, because these might lead to even more difficulties with breathing. The first 12 consented patients will receive nebulised rt-PA in addition to standard of care (SOC). The second group of 12 patients will receive SOC alone as a comparison. To evaluate efficacy, the improvement of oxygen levels over time and safety will be be monitored throughout. Blood samples will be taken to measure markers of clotting and inflammation in both groups. From the end of the treatment phase (after Day 3) both groups will be followed up in accordance with SOC.

NCT04356833 COVID Drug: nebulised recombinant tissue-Plasminogen Activator (rt-PA)

Primary Outcomes

Description: Percentage change in PaO2/FiO2 ratio from baseline and to day 5 (96 hrs ± 2 hrs) post treatment and day 7 (144 hrs ± 4hrs) in the groups receiving rt-PA

Measure: treatment efficacy - Percentage change in PaO2/FiO2 ratio

Time: 144 hours

Description: Incidence and severity of major bleeding events

Measure: Safety as measured by bleeds

Time: 28 days

Description: Incidence and severity of adverse events More than 1 treatment-emergent serious adverse event (SAE) during and up to 24 hours of the treatment

Measure: Safety as measured by other (non-bleed related) adverse events

Time: 28 days

Description: Decrease in fibrinogen levels over 72 hrs post initiation of treatment (>50%).

Measure: Safety as measured by fibrinogen levels

Time: 72 hours

Secondary Outcomes

Description: Absolute change in PaO2/FiO2 ratio post treatment assessed at day 5 (96 hrs ± 2 hrs) and day 7 (144 hrs ± 4hrs)

Measure: Absolute change in PaO2/FiO2 ratio

Time: 7 days

Description: Changes in respiratory compliance from baseline and absolute values at day 5 (96 hrs ± 2 hrs) and day 7 (144 hrs ± 4hrs), as measured by PIP (Peak inspiratory pressure) minus PEEP (Positive end-expiratory pressure) at each timepoint

Measure: Changes in respiratory compliance

Time: 7 days

Description: Clinical status as assessed by a 7-point WHO ordinal scale at baseline and daily up to day 7. Points on the scale are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring low flow supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized

Measure: Clinical status as determined by a 7 point ordinal scale

Time: 7 days

Description: Mean daily Sequential Organ Failure Assessment (SOFA) score at baseline through up to day 7 (done daily)

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: 7 days

Description: Duration of oxygenation free days, up to 28 days or death or discharge, whichever occurs first.

Measure: Follow up period - oxygen free days

Time: 28 days

Description: In follow up period, ventilator free days, up to 28 days or death or discharge, whichever occurs first.

Measure: Follow up period - ventilator free days

Time: 28 days

Description: In follow up period, intensive care stay, up to 28 days or death or discharge, whichever occurs first.

Measure: Follow up period - intensive care stay

Time: 28 days

Description: Incidence of either new oxygen use via ventilation in the first 28 days. These include non-invasive ventilation or high flow oxygen devices

Measure: New oxygen via ventilation use - incidence

Time: 28 days

Description: Total duration of new oxygen use via ventilation in the first 28 days. These include non-invasive ventilation or high flow oxygen devices.

Measure: New oxygen via ventilation use - duration

Time: 28 days

Description: Incidence of new mechanical ventilation use during in the first 28 days

Measure: Incidence of new mechanical ventilation use

Time: 28 days

Description: Duration of new mechanical ventilation use during in the first 28 days

Measure: Duration of new mechanical ventilation use

Time: 28 days

Description: In hospital mortality

Measure: In hospital mortality

Time: 28 days

CovidResearchTrials by Shray Alag

Covid 19 Research using Clinical Trials (Home Page)

nebulised recombinant tissue-Plasminogen Activator (rt-PA)Wiki

Developed by Shray Alag

Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (1)

Correlated HPO Terms (0)

Clinical Trials

1 A Pilot, Open Label, Phase II Clinical Trial of Nebulised Recombinant Tissue-Plasminogen Activator (Rt-PA)

NCT04356833 COVID Drug: nebulised recombinant tissue-Plasminogen Activator (rt-PA)

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)