Covid19Phase 2NCT04745442
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
A Phase 2 study testing Antithrombin + best available treatment and Best available treatment in people with Covid19 and Severe Acute Respiratory Syndrome, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19, Severe Acute Respiratory Syndrome, Distress Respiratory Syndrome
- What is being tested?
- Antithrombin + best available treatment and Best available treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 27 Apr 2020to 15 Jan 2021
- Phase
- Phase 2
- 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
- Age >= 18 and < 85 years
- COVID-19 diagnosis confirmed.
- Radiological image compatible with COVID-19
- Present any of the following clinical-functional criteria considered RISK:
- Respiratory distress: Tachypnea > 26 breaths / minute
- PaO2 / FiO2 oxygenation index # 300
Show all 9Show fewer
- Alteration of one or more of the following parameters:
- c.i. DD> 1,000 µg / L c.ii. Ferritin> 800 ng / mL 4.c.iii. Lymphocytes <800 cells / µL 4.c.iv. PCR> 100 mg / L 4.c.v. LDH> 500 U / L c.vi. IL-6> 15 pg / mL
- Direct or delegated verbal informed consent
Who cannot join
- Signs of active bleeding
- Immunosuppression by cancer or transplant
- Intolerance or allergy to AT or its components
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS.
- Being tested
- Antithrombin + best available treatment, Best available treatment
- Keywords
- Antithrombin, COVID-19, Distress Respiratory Syndrome
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin + best available treatmentDrug
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
Best available treatmentDrug
The subject will be treated with the best available treatment for COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Best available treatment + Antithrombin | Experimental | The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19. Receives: Drug: Antithrombin + best available treatment |
| Best available treatment | Active comparator | The subject will be treated with the best available treatment for COVID-19. Receives: Drug: Best available treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Secondary outcomes (13)
Time to clinical improvement (decreased risk of developing SARS or death)
Time (in days) to improvement in the National Early Warning (NEWS) Score 2. Defined as the time, in days, from the start of treatment a two-point improvement on this scale.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Measured: At 24 and 48 hours.
Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
Time until the absence of oxygen need to maintain a basal saturation >= 92%.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Time to radiological improvement in radiological report.
Time to radiological improvement in radiological report.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of non-invasive mechanical ventilation.
Time (in days) of non-invasive mechanical ventilation.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of invasive mechanical ventilation.
Time (in days) of invasive mechanical ventilation.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Mortality rate in hospital and one month after pharmacological intervention.
Mortality rate in hospital and one month after pharmacological intervention.
Measured: One month after pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Measured: One month after pharmacological intervention.
Incidence of adverse events related to medication and its administration.
Incidence of adverse events related to medication and its administration.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence in the appearance of allergic type hypersensitivity
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of B19 parvovirus infection
Incidence of B19 parvovirus infection
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Bleeding
Incidence of Bleeding
Measured: At day 31 after randomization or hospital discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start27 Apr 2020
- Primary completion20 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ángel Salvatierra, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745442
- Sponsor's protocol ID
- ANTITROMBINA
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04745442
- Acronym / sponsor ID
- ANTITROMBINA
- Keywords
- Antithrombin, COVID-19, Distress Respiratory Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 9 Feb 2021 (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.
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best available treatment + Antithrombin | Experimental | Drug: Antithrombin + best available treatmentThe subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19. |
| Best available treatment | Active comparator | Drug: Best available treatmentThe subject will be treated with the best available treatment for COVID-19. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 and < 85 years
- COVID-19 diagnosis confirmed.
- Radiological image compatible with COVID-19
- Present any of the following clinical-functional criteria considered RISK:
- c.i. DD> 1,000 µg / L c.ii. Ferritin> 800 ng / mL 4.c.iii. Lymphocytes <800 cells / µL 4.c.iv. PCR> 100 mg / L 4.c.v. LDH> 500 U / L c.vi. IL-6> 15 pg / mL
Key exclusion criteria (4 listed)
- Signs of active bleeding
- Immunosuppression by cancer or transplant
- Intolerance or allergy to AT or its components
- Pregnancy
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 |
|---|---|---|
| Antithrombin + best available treatmentThe subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19. | Drug | Best available treatment + Antithrombin |
| Best available treatmentThe subject will be treated with the best available treatment for COVID-19. | Drug | Best available treatment |
Primary outcome
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
13 secondary outcomes
Time to clinical improvement (decreased risk of developing SARS or death)
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Time frame: At 24 and 48 hours.
Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Time to radiological improvement in radiological report.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of non-invasive mechanical ventilation.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of invasive mechanical ventilation.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Mortality rate in hospital and one month after pharmacological intervention.
Time frame: One month after pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Time frame: One month after pharmacological intervention.
Incidence of adverse events related to medication and its administration.
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence in the appearance of allergic type hypersensitivity
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of B19 parvovirus infection
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Bleeding
Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
Ángel Salvatierra, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antithrombin + best available treatment and Best available treatment in people with Covid19 and Severe Acute Respiratory Syndrome, run by Maimónides Biomedical Research Institute of Córdoba at 1 site 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation (time frame: At day 31 after randomization or hospital discharge (whichever occurs first)). 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 9 Feb 2021.