ApTOLL for the Treatment of COVID-19

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

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 Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Other: Saline; Drug: ApTOLL

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: David Segarra; Phone Number: +34 910 568 359; Email: d.segarra@aptatargets.com
• Study Contact Backup: Name: Macarena Hernández, PhD; Phone Number: +34 910 568 359; Email: m.hernandez@aptatargets.com

Study Locations

• Spain
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Madrid, Spain
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain
    • Hospital Universitario La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion	Other: Saline; Saline for intravenous infusion
Experimental: Dose 1; Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion	Drug: ApTOLL; ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
Experimental: Dose 2; Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion	Drug: ApTOLL; ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
Experimental: Dose 3; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Macarena Hernández Jiménez
• Collaborators: Centro para el Desarrollo Tecnológico Industrial
• Investigators: Study Director: Macarena Hernández, PhD, aptaTargets S.L.; Study Director: Marc Ribó, MD, PhD, aptaTargets S.L.; Principal Investigator: Sergio Serrano, MD, Hospital Universitario Ramón y Cajal; Principal Investigator: Ignacio Santos, MD, Hospital Universitario La Princesa

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: APTACOVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not planned this point yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No