NCT05293236

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jan 2022

Typical duration for phase_1 covid19

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

March 18, 2022

Last Update Submit

August 4, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

  • Incidence of Death

    Number of dead patients at the end of the study

    From dosing to day 28 after administration

  • Incidence of Adverse Events as assessed by MedDRA

    Adverse events that occur during the study

    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)

    From dosing to day 28 after administration

  • Number of patients with treatment-related alterations Complement Factors

    Complement activation determined in blood

    From dosing to day 28 after administration

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Other: Saline

Dose 1

EXPERIMENTAL

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

Drug: ApTOLL

Dose 2

EXPERIMENTAL

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

Drug: ApTOLL

Dose 3

EXPERIMENTAL

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

Drug: ApTOLL

Interventions

ApTOLLDRUG

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

Dose 1Dose 2Dose 3
SalineOTHER

Saline for intravenous infusion

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

TLR4 antagonist ApTOLLSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Macarena Hernández, PhD

    aptaTargets S.L.

    STUDY DIRECTOR

  • Sergio Serrano, MD

    Hospital Universitario Ramón y Cajal

    PRINCIPAL INVESTIGATOR

  • Ignacio Santos, MD

    Hospital Universitario La Princesa

    PRINCIPAL INVESTIGATOR

  • Marc Ribó, MD, PhD

    aptaTargets S.L.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 24, 2022

Study Start

January 14, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

ES(4)