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ApTOLL for the Treatment of COVID-19

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
ApTOLL
Saline
Sponsored by
Macarena Hernández Jiménez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de Burgos
  • Hospital Universitario Clínico San Carlos
  • Hospital Universitario La Princesa
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Dose 1

Dose 2

Dose 3

Arm Description

Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion

Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion

Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion

Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion

Outcomes

Primary Outcome Measures

Incidence of Death
Number of dead patients at the end of the study
Incidence of Adverse Events as assessed by MedDRA
Adverse events that occur during the study
Number of patients with treatment-related alterations coagulation parameters
Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)
Number of patients with treatment-related alterations Complement Factors
Complement activation determined in blood

Secondary Outcome Measures

Full Information

First Posted
March 18, 2022
Last Updated
August 4, 2023
Sponsor
Macarena Hernández Jiménez
Collaborators
Centro para el Desarrollo Tecnológico Industrial
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1. Study Identification

Unique Protocol Identification Number
NCT05293236
Brief Title
ApTOLL for the Treatment of COVID-19
Official Title
A Double Blind, Placebo-Controlled, Randomized, Phase Ib Clinical Study of ApTOLL for the Treatment of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients due to reduced incidence in the COVID-19 infected population in Spain
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Macarena Hernández Jiménez
Collaborators
Centro para el Desarrollo Tecnológico Industrial

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion
Intervention Type
Drug
Intervention Name(s)
ApTOLL
Intervention Description
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline for intravenous infusion
Primary Outcome Measure Information:
Title
Incidence of Death
Description
Number of dead patients at the end of the study
Time Frame
From dosing to day 28 after administration
Title
Incidence of Adverse Events as assessed by MedDRA
Description
Adverse events that occur during the study
Time Frame
From dosing to day 28 after administration
Title
Number of patients with treatment-related alterations coagulation parameters
Description
Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)
Time Frame
From dosing to day 28 after administration
Title
Number of patients with treatment-related alterations Complement Factors
Description
Complement activation determined in blood
Time Frame
From dosing to day 28 after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women with age ≥18 and ≤85 years. 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. Laboratory-confirmed SARS-CoV-2 infection. Informed consent obtained . Hypoxia (SpO2<95%). Documented lung opacities/infiltrates. Confirmed hyperinflammation. Exclusion Criteria: Onset of symptoms of COVID-19 >14 days. Pregnant or nursing (lactating) women. Hospitalized >10 days for COVID-19. Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation. Systolic blood pressure < 90 mmHg. Serious concomitant illness. Recent treatment with cell-depleting therapies. Enrolled in another clinical trial. Severe renal dysfunction. In the opinion of the investigator, unable to comply with the requirements to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Macarena Hernández, PhD
Organizational Affiliation
aptaTargets S.L.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergio Serrano, MD
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Santos, MD
Organizational Affiliation
Hospital Universitario La Princesa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Ribó, MD, PhD
Organizational Affiliation
aptaTargets S.L.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Burgos
City
Burgos
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have not planned this point yet
Links:
URL
http://aptatargets.com
Description
Related Info

Learn more about this trial

ApTOLL for the Treatment of COVID-19

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