ApTOLL for the Treatment of COVID-19

Macarena Hernández Jiménez

Status and phase: Terminated; Phase 1

Conditions: COVID-19

Treatments: Other: Saline; Drug: ApTOLL

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05293236

APTACOVID

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

5 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Saline

Dose 1

Experimental group

Description:

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

Treatment:

Drug: ApTOLL

Dose 2

Experimental group

Description:

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

Treatment:

Drug: ApTOLL

Dose 3

Experimental group

Description:

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

Treatment:

Drug: ApTOLL