COVID-19
Conditions
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.
Interventions
DRUGApTOLL
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
OTHERSaline
Saline for intravenous infusion
Sponsors
Centro para el Desarrollo Tecnológico Industrial
Macarena Hernández Jiménez
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women with age ≥18 and ≤85 years. 2. 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. 3. Laboratory-confirmed SARS-CoV-2 infection. 4. Informed consent obtained . 5. Hypoxia (SpO2\<95%). 6. Documented lung opacities/infiltrates. 7. Confirmed hyperinflammation.
Exclusion criteria
1. Onset of symptoms of COVID-19 \>14 days. 2. Pregnant or nursing (lactating) women. 3. Hospitalized \>10 days for COVID-19. 4. Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation. 5. Systolic blood pressure \< 90 mmHg. 6. Serious concomitant illness. 7. Recent treatment with cell-depleting therapies. 8. Enrolled in another clinical trial. 9. Severe renal dysfunction. 10. In the opinion of the investigator, unable to comply with the requirements to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed