ApTOLL for the Treatment of COVID-19
Study Details
Study Description
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 (CSS). To this aim, this Phase Ib clinical study (APTACOVID) pretends to determine whether ApTOLL, in combination with the standard of care, is safe and shows any biological effect) in those patients infected with SARS-CoV-2 who are not developed CSS yet.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion |
Other: Saline
Saline for intravenous infusion
|
| Experimental: Dose 1 Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion |
Drug: ApTOLL
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
|
| Experimental: Dose 2 Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion |
Drug: ApTOLL
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
|
| Experimental: Dose 3 Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion |
Drug: ApTOLL
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
|
Outcome Measures
Primary Outcome Measures
- Incidence of Death [From dosing to day 28 after administration]
Number of dead patients at the end of the study
- Incidence of Adverse Events as assessed by MedDRA [From dosing to day 28 after administration]
Adverse events that occur during the study
- Number of patients with treatment-related alterations coagulation parameters [From dosing to day 28 after administration]
Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)
- Number of patients with treatment-related alterations Complement Factors [From dosing to day 28 after administration]
Complement activation determined in blood
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men or women with age ≥18 and ≤85 years.
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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.
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Laboratory-confirmed SARS-CoV-2 infection.
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Informed consent obtained .
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Hypoxia (SpO2<95%).
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Documented lung opacities/infiltrates.
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Confirmed hyperinflammation.
Exclusion Criteria:
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Onset of symptoms of COVID-19 >14 days.
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Pregnant or nursing (lactating) women.
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Hospitalized >10 days for COVID-19.
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Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation.
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Systolic blood pressure < 90 mmHg.
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Serious concomitant illness.
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Recent treatment with cell-depleting therapies.
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Enrolled in another clinical trial.
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Severe renal dysfunction.
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In the opinion of the investigator, unable to comply with the requirements to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Macarena Hernández Jiménez
- Centro para el Desarrollo Tecnológico Industrial
Investigators
- Study Director: Macarena Hernández, PhD, aptaTargets S.L.
- Principal Investigator: Sergio Serrano, MD, Hospital Universitario Ramón y Cajal
- Principal Investigator: Ignacio Santos, MD, Hospital Universitario La Princesa
- Study Director: Marc Ribó, MD, PhD, aptaTargets S.L.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- APTACOVID