ApTOLL for the Treatment of COVID-19

Phase 1

Terminated

• Conditions: COVID-19
• Interventions: Other: Saline; Drug: ApTOLL

• Registration Number: NCT05293236
• Lead Sponsor: Macarena Hernández Jiménez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-14
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion
Dose 1	ApTOLL	Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion
Dose 2	ApTOLL	Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion
Dose 3	ApTOLL	Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion

Primary Outcome Measures

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

Trial Locations

Locations (4)

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain