ApTOLL for the Treatment of COVID-19

COVID-19 Clinical Trial

Official title:

A Double Blind, Placebo-Controlled, Randomized, Phase Ib Clinical Study of ApTOLL for the Treatment of COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05293236
• Other study ID #: APTACOVID
• Status: Terminated
• Phase: Phase 1
• Start date: January 14, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: aptaTargets S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Other:
• Saline
Saline for intravenous infusion

Locations

Country	Name	City	State
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
Macarena Hernández Jiménez	Centro para el Desarrollo Tecnológico Industrial

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Death	Number of dead patients at the end of the study	From dosing to day 28 after administration
Primary	Incidence of Adverse Events as assessed by MedDRA	Adverse events that occur during the study	From dosing to day 28 after administration
Primary	Number of patients with treatment-related alterations coagulation parameters	Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)	From dosing to day 28 after administration
Primary	Number of patients with treatment-related alterations Complement Factors	Complement activation determined in blood	From dosing to day 28 after administration

External Links

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