ApTOLL for the Treatment of COVID-19

Phase 1TerminatedNCT05293236

Macarena Hernández Jiménez5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COVID-19

Interventions

ApTOLLDRUG

ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)

SalineOTHER

Saline for intravenous infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (4)

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario La Princesa

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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