Status:
TERMINATED
ApTOLL for the Treatment of COVID-19
Lead Sponsor:
Macarena Hernández Jiménez
Collaborating Sponsors:
Centro para el Desarrollo Tecnológico Industrial
Conditions:
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
There is a clear and urgent medical need of developing new medicinal products for COVID-19 since there are poor pharmacological tools to block the progression of patients to cytokine storm syndrome (C...
Eligibility Criteria
Inclusion
- Men or women with age ≥18 and ≤85 years.
- In case of women of childbearing potential (WOCBP), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included.
- Laboratory-confirmed SARS-CoV-2 infection.
- Informed consent obtained .
- Hypoxia (SpO2\<95%).
- Documented lung opacities/infiltrates.
- Confirmed hyperinflammation.
Exclusion
- Onset of symptoms of COVID-19 \>14 days.
- Pregnant or nursing (lactating) women.
- Hospitalized \>10 days for COVID-19.
- Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation.
- Systolic blood pressure \< 90 mmHg.
- Serious concomitant illness.
- Recent treatment with cell-depleting therapies.
- Enrolled in another clinical trial.
- Severe renal dysfunction.
- In the opinion of the investigator, unable to comply with the requirements to participate in the study.
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05293236
Start Date
January 14 2022
End Date
December 31 2022
Last Update
August 7 2023
Active Locations (4)
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1
Hospital Universitario de Burgos
Burgos, Spain
2
Hospital Universitario Clínico San Carlos
Madrid, Spain
3
Hospital Universitario La Princesa
Madrid, Spain
4
Hospital Universitario Ramón y Cajal
Madrid, Spain