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Allocetra-OTSWiki

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


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug875 Dexmedetomidine Injectable Product Wiki 1.00

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D000071257 Emergence Delirium NIH 1.00
D003693 Delirium NIH 0.50
D007249 Inflammation NIH 0.19
D013577 Syndrome NIH 0.10
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Multi-Center, Open-Label Study, Evaluating Safety of Allocetra-OTS for the Prevention of Organ-Failure Deterioration in Severe Patients With COVID-19 and Respiratory Dysfunction

This is a multi-center, open-label study evaluating the safety of Allocetra-OTS, in 5 subjects with severe COVID-19 and respiratory dysfunction. Subjects, who will be identified as suffering from COVID-19, will be recruited. After signing an informed consent by the patient and, within 24+6 hours following the time of eligibility (time 0), on Day 1, eligible recipient subjects will receive single intravenous (IV) administration of investigational product as described below. Subjects will be hospitalized for COVID-19, and later as medically indicated. Following investigational product (IP) administration (Day 1), subjects will be followed for efficacy and safety assessments through 28 days.

NCT04513470 COVID-19 Biological: Allocetra-OTS

Primary Outcomes

Description: Incidence rates and severity of any Adverse Events (AE) and Serious Adverse Events (SAE)

Measure: Assessment of safety by determining the number of participants with any Adverse Events (AE) and Serious Adverse Events (SAE)

Time: 28 days follow up

Secondary Outcomes

Description: Recovery from COVID-19 will be determined by the following measures: The percentage of subjects reporting to 'Asymptomatic' by the NIH classification and the number of days to reach this classification, and/or The percentage of subjects negative for SARS-CoV-2 RNA (by PCR) and the number of days for viral clearance (negative PCR results)

Measure: Preliminary Efficacy: Recovery from COVID-19 as determined by negative PCR or asymptomatic by the NIH classification for the severity of illness

Time: 28 days follow up

Description: Incidence rate of Mortality from any cause

Measure: Mortality

Time: 28 days follow up

Description: Respiratory function will be assessed by measuring the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2). Patients with PaO2/FiO2 ratio < 300mmHg are considered severe patients. • The PaO2/FiO2 ratio and its change from the baseline value will be measured on days, 3, 5, 7, 14, and 28.

Measure: Preliminary Efficacy: To assess prevention of respiratory deterioration associated with COVID-19 by measuring the PaO2/FiO2 ratio

Time: On days, 3, 5, 7, 14, and 28 during 28 days follow up

Description: Cumulative days in the Intensive care unit (ICU) or COVID-19 ICU or COVID-19 department and/or in hospital.

Measure: Hospitalization

Time: 28 days follow up

Description: Number of ventilator-free days.

Measure: Life support

Time: 28 days follow up

Description: Change from baseline of the new NIH Patient Classification for the severity of illness.

Measure: Clinical status by the new NIH Patient Classification for the severity of illness

Time: 28 days follow up

Description: Change from baseline of National Early Warning Score (NEWS2).

Measure: Clinical status by NEWS2

Time: 28 days follow up

Description: Percentage of subjects reporting each severity rating on a 7-point ordinal scale at day 28 as follows: Death. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Not hospitalized, limitation on activities. Not hospitalized, no limitations on activities.

Measure: Support measurements: percentage of subjects reporting each severity rating on a 7-point ordinal scale

Time: 28 days follow up

Description: Time to improvement of one category from admission using this 7-point ordinal scale, as follows: Death. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Not hospitalized, limitation on activities. Not hospitalized, no limitations on activities.

Measure: Support measurements: improvement of severity rating on a 7-point ordinal scale

Time: 28 days follow up

Description: Evaluation of clearance of the virus using PCR (Negative for SARS-CoV-2 RNA) on days 14 and 28 (if not negative before).

Measure: Virus Clearance

Time: Within the 28 days follow up, tested on days 14 and 28

Description: Serum concentrations (pg/ml) of cytokines, chemokines, complement, hematopoietic growth factors, and other immunomodulating factors (including HMGB1) will be measured before and after the infusion of Allocetra-OTS and periodically throughout 28 days follow up.

Measure: Exploratory: Serum cytokines/chemokines and immunomodulating factors

Time: 28 days follow up

Description: Differential blood counts will be performed before and after the infusion of Allocetra-OTS and periodically throughout 28 days follow up.

Measure: Exploratory: complete blood counts

Time: 28 days follow up

Description: Histone and cell-free DNA plasma levels will be measured before and after the infusion of Allocetra-OTS and periodically throughout 28 days follow up.

Measure: Exploratory: Histone and cell-free DNA levels

Time: 28 days follow up

No related HPO nodes (Using clinical trials)