COVID-19Phase 1NCT05293236
ApTOLL for the Treatment of COVID-19
A Phase 1 study testing ApTOLL and Saline in people with COVID-19, run by Macarena Hernández Jiménez at 4 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- ApTOLL and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 4 sitesSpain
- Study dates
- 14 Jan 2022to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario de Burgos
Burgos
Hospital Universitario Clínico San Carlos
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Universitario Ramón y Cajal
Madrid
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- ApTOLL, Saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApTOLLDrug
ApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4)
SalineOther
Saline for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion Receives: Other: Saline |
| Dose 1 | Experimental | Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion Receives: Drug: ApTOLL |
| Dose 2 | Experimental | Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion Receives: Drug: ApTOLL |
| Dose 3 | Experimental | Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion Receives: Drug: ApTOLL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Death
Number of dead patients at the end of the study
Measured: From dosing to day 28 after administration
Incidence of Adverse Events as assessed by MedDRA
Adverse events that occur during the study
Measured: 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)
Measured: From dosing to day 28 after administration
Number of patients with treatment-related alterations Complement Factors
Complement activation determined in blood
Measured: From dosing to day 28 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Lack of patients due to reduced incidence in the COVID-19 infected population in Spain
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macarena Hernández Jiménez
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro para el Desarrollo Tecnológico Industrial
- Responsible party
- Sponsor-investigator, Macarena Hernández Jiménez, aptaTargets S.L.
- Investigators
- Macarena Hernández, PhD, Study director, aptaTargets S.L.Sergio Serrano, MD, Principal investigator, Hospital Universitario Ramon y CajalIgnacio Santos, MD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaMarc Ribó, MD, PhD, Study director, aptaTargets S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293236
- Sponsor's protocol ID
- APTACOVID
- Status last verified
- Aug 2023
- First submitted
- 18 Mar 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not planned this point yet
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Randomized, Phase Ib Clinical Study of ApTOLL for the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT05293236
- Acronym / sponsor ID
- APTACOVID
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients due to reduced incidence in the COVID-19 infected population in Spain
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Macarena Hernández JiménezIndustry (pharma, biotech, devices)
- Collaborators
- Centro para el Desarrollo Tecnológico Industrial
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: SalineNine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion |
| Dose 1 | Experimental | Drug: ApTOLLSeven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion |
| Dose 2 | Experimental | Drug: ApTOLLSeven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion |
| Dose 3 | Experimental | Drug: ApTOLLSeven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApTOLLApTOLL is an aptamer (DNA single strain) designed to block TLR4 (toll-like receptor 4) | Drug | Dose 1, Dose 2, Dose 3 |
| SalineSaline for intravenous infusion | Other | Placebo |
Primary outcome
Incidence of Death
Time frame: 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
Time frame: From dosing to day 28 after administration
Adverse events that occur during the study
Number of patients with treatment-related alterations coagulation parameters
Time frame: 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
Time frame: From dosing to day 28 after administration
Complement activation determined in blood
Results and safety
The study was stopped early (reason given: Lack of patients due to reduced incidence in the COVID-19 infected population in Spain). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We have not planned this point yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Macarena Hernández, PhD study director
aptaTargets S.L.
Sergio Serrano, MD principal investigator
Hospital Universitario Ramon y Cajal
Ignacio Santos, MD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ApTOLL and Saline in people with COVID-19, run by Macarena Hernández Jiménez at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients due to reduced incidence in the COVID-19 infected population in Spain). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Death (time frame: From dosing to day 28 after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.