Clinical trial NCT05293236: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: aptaTargets S.L.
Sponsor class: INDUSTRY
Collaborators: name: Centro para el Desarrollo Tecnológico Industrial
First posted: 2022-03-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Death
timeFrame: From dosing to day 28 after administration
measure: Incidence of Adverse Events as assessed by MedDRA
timeFrame: From dosing to day 28 after administration
measure: Number of patients with treatment-related alterations coagulation parameters
timeFrame: From dosing to day 28 after administration
measure: Number of patients with treatment-related alterations Complement Factors
timeFrame: From dosing to day 28 after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: aptaTargets S.L.
name: Macarena Hernández, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Ramón y Cajal
name: Sergio Serrano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Princesa
name: Ignacio Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: aptaTargets S.L.
name: Marc Ribó, MD, PhD
role: STUDY_DIRECTOR
References: