A Phase 1 interventional study of ApTOLL and Saline in COVID-19, sponsored by Macarena Hernández Jiménez. Terminated at 4 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by Macarena Hernández Jiménez · Phase 1, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Macarena Hernández Jiménez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion
Other: Saline
Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion
Drug: ApTOLL
Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion
Drug: ApTOLL
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)
Saline for intravenous infusion
Incidence of Death
Number of dead patients at the end of the study
Time frame: From dosing to day 28 after administration
Incidence of Adverse Events as assessed by MedDRA
Adverse events that occur during the study
Time frame: From dosing to day 28 after administration
Number of patients with treatment-related alterations coagulation parameters
Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)
Time frame: From dosing to day 28 after administration
Number of patients with treatment-related alterations Complement Factors
Complement activation determined in blood
Time frame: From dosing to day 28 after administration
Plan to share: Undecided — We have not planned this point yet
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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