Status:
SUSPENDED
Ultra Low Doses of Therapy With Radiation Applicated to COVID-19
Lead Sponsor:
Fundacion GenesisCare
Collaborating Sponsors:
Hospital La Milagrosa
Hospital Vithas Valencia Consuelo
Conditions:
Pneumonia, Viral
Cytokine Storm
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), i...
Detailed Description
The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is ...
Eligibility Criteria
Inclusion
- Age \> 18 years-old.
- Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
- Charlson Comorbidity Index (CCI) less than 6 score.
- Poor or no response to standard medical treatment, based on:
- \*% Sat02 \<93%
- Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)
- Pa02 / Fi02 (blood gas analysis) \<300 mmHg
- 1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.
- Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS\> 5 by a diagnostic baseline CT scan.
- Eastern Cooperative Oncology Group (ECOG) Status \< or = 3
- Life expectancy (LE)\> 1 month at hospital admission for COVID-19
- No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).
- Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.
Exclusion
- Failure to meet the inclusion criteria.
- Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
- Patients admitted in ICU.
- Refusal of treatment after verbal information.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 21 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04394182
Start Date
April 21 2020
End Date
March 21 2022
Last Update
March 29 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital La Milagrosa, GenesisCare
Madrid, Spain, 28010
2
Hospital Vithas Valencia Consuelo
Valencia, Spain, 46007