COVIDPhase 3RAPID-BRAZILNCT04444700
A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic
A Phase 3 study testing Therapeutic anticoagulation in people with COVID and Coronavirus Infection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Coronavirus Infection, Severe Acute Respiratory Syndrome
- What is being tested?
- Therapeutic anticoagulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jul 2020to 14 Oct 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria are:
- laboratory confirmed diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol or by nucleic acid based isothermal amplification.Positive test prior to hospital admission OR within first 5 days (i.e. 120 hours) after hospital admission;
- admitted to hospital for COVID-19;
- one D-dimer value above ULN (5 days (i.e. 120 hours) of hospital admission) and either: a) D-Dimer ≥2 times ULN; or b) D-dimer above ULN and oxygen saturation ≤ 93% on room air;
- ≥18 years of age;
- informed consent from the patient (or legally authorized substitute decision maker).
The exclusion criteria are:
- pregnancy;
- hemoglobin <80 g/L in the last 72 hours;
- platelet count <50 x 10^9/L in the last 72 hours;
- known fibrinogen <1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
- known INR >1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
- patient already on intermediate dosing of LMWH that cannot be changed (determination of what constitutes an intermediate dose is to be at the discretion of the treating clinician taking the local institutional thromboprophylaxis protocol for high risk patients into consideration);
- patient already on therapeutic anticoagulation at the time of screening (low or high dose nomogram UFH, LMWH, warfarin, direct oral anticoagulant (any dose of dabigatran, apixaban, rivaroxaban, edoxaban);
- patient on dual antiplatelet therapy, when one of the agents cannot be stopped safely;
- known bleeding within the last 30 days requiring emergency room presentation or hospitalization;
- known history of a bleeding disorder of an inherited or active acquired bleeding disorder;
- known history of heparin-induced thrombocytopenia;
- known allergy to UFH or LMWH;
- admitted to the intensive care unit at the time of screening;
- treated with non-invasive positive pressure ventilation or invasive mechanical ventilation at the time of screening (of note: high flow oxygen delivery via nasal cannula is acceptable and is not an exclusion criterion).
- imminent death according to the judgement of the most responsible physician
- enrollment in another clinical trial of antithrombotic therapy involving pre-intensive care unit hospitalized patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19
Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients admitted for COVID-19 with an elevated D-dimer.
Read the detailed description
2-arm, parallel, pragmatic, multi-centre, open-label randomized controlled trial to determine the effect of therapeutic anticoagulation, with low molecular weight heparin or unfractionated heparin (high dose nomogram), compared to standard care in hospitalized patients with COVID-19 and an elevated D-dimer on the composite outcome of intensive care unit (ICU) admission, non-invasive positive pressure ventilation, invasive mechanical ventilation or death at 28 days. Eligible participants will be randomized to one of two treatment regimens, receiving either therapeutic anticoagulation or standard care until discharged from hospital, death or day 28.
The primary composite outcome of ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation, or all-cause death up to 28 days.
Key secondary outcomes between study arms up to day 28 include:
- All-cause death
- Composite outcome of ICU admission or all-cause death
- Composite outcome of mechanical ventilation or all-cause death
- Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation
- Number of participants who received red blood cell transfusion (≥1 unit)
- Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
- Renal replacement therapy;
- Number of hospital-free days alive
- Number of ICU-free days alive
- Number of ventilator-free days alive
- Number of organ support-free days alive
- Number of participants with venous thromboembolism
- Number of participants with arterial thromboembolism
- Number of participants with heparin induced thrombocytopenia
- Changes in D-dimer up to day 3
The treatment arm is therapeutic anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH, high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin, or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to the center-specific protocol. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. The standard care arm is the administration of LMWH, UFH or fondaparinux at thromboprophylactic doses in the absence of contraindication.
No study specific bloodwork will be ordered aside from a single D-dimer test (if not collected through standard of care) up to and including day 3 after randomization for all participants in both study arms. In those on the active treatment arm who are receiving UFH, the aPTT or UFH anti-Xa will be drawn according to local institutional UFH nomogram protocol guidance. All laboratory results will be collected from standard of care from admission to hospital discharge, death or 28 days, where available. An optional biobanking component will collect blood at baseline and 2 follow up time points.
This study will immediately impact the clinical care of patients with severe COVID-19 internationally, whether the findings are positive or negative, as COVID-19 coagulopathy is a highly prevalent complication of severe COVID-19 and may precede the respiratory manifestations that characterize it.
- Conditions
- COVID, Coronavirus Infection, Severe Acute Respiratory Syndrome, Thromboembolism, Venous, Anticoagulants and Bleeding Disorders
- Being tested
- Therapeutic anticoagulation
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, Venous Thromboembolism, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic anticoagulationDrug
The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Receives: Drug: Therapeutic anticoagulation |
| Standard care | No intervention | Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Measured: up to 28 days
Secondary outcomes (15)
All-cause death
All-cause death
Measured: Up to 28 days
Composite outcome of ICU admission or all-cause death
Composite outcome of ICU admission or all-cause death
Measured: Up to 28 days
Composite outcome of mechanical ventilation or all-cause death
Composite outcome of mechanical ventilation or all-cause death
Measured: Up to 28 days
Major bleeding
Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation
Measured: Up to 28 days
Red blood cell transfusion
Red Blood Cell transfusion (greater than or equal to 1 unit)
Measured: Up to 28 days
Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipiate and/or fibrinogen concentrate
Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipiate and/or fibrinogen concentrate
Measured: Up to 28 days
Renal replacement therapy
Renal replacement therapy defined as continuous renal replacement therapy or intermittent hemodialysis
Measured: Up to 28 days
Hospital-free days alive up to day 28
Hospital-free days alive up to day 28
Measured: Up to 28 days
ICU-free days alive up to day 28
ICU-free days alive up to day 28
Measured: Up to 28 days
Ventilator-free days alive up to day 28
Ventilator-free days alive up to day 28
Measured: Up to 28 days
Organ support-free days alive up to day 28
Organ support-free days alive up to day 28
Measured: Up to 28 days
Venous thromboembolism
Venous thromboembolism
Measured: Up to 28 days
Arterial thromboembolism
Arterial thromboembolism
Measured: Up to 28 days
Heparin induced thrombocytopenia
Heparin induced thrombocytopenia
Measured: Up to 28 days
Changes in D-dimer up to day 3
D-dimer
Measured: Up to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start4 Jul 2020
- Primary completion10 May 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a 2-arm, parallel, pragmatic, multi-centre, open-label randomized controlled trial to determine the effect of therapeutic anticoagulation on the composite outcome of ICU admission, mechanical ventilation and/or death in hospitalized patients with COVID-19.
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, University of Vermont Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter Juni, MD, FESC, Principal investigator, St Michael's Hospital, Li Ka Shing Knowledge Institute, University of TorontoElnara M Negri, MD, PhD, Principal investigator, Laboratório de Investigação Médica da FMUSPHeraldo P de Souza, MD, PhD, Principal investigator, Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSPHassan Rahhal, MD, Principal investigator, Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444700
- Sponsor's protocol ID
- CAAE: 33109220.7.0000.0068
- Acronym
- RAPID-BRAZIL
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sholzberg M, Tang GH, Rahhal H, AlHamzah M, Kreuziger LB, Ni Ainle F, Alomran F, Alayed K, Alsheef M, AlSumait F, Pompilio CE, Sperlich C, Tangri S, Tang T, Jaksa P, Suryanarayan D, Almarshoodi M, Castellucci L, James PD, Lillicrap D, Carrier M, Beckett A, Colovos C, Jayakar J, Arsenault MP, Wu C, Doyon K, Andreou ER, Dounaevskaia V, Tseng EK, Lim G, Fralick M, Middeldorp S, Lee AYY, Zuo F, da Costa BR, Thorpe KE, Negri EM, Cushman M, Juni P; RAPID Trial investigators. Heparin for Moderately Ill Patients with Covid-19. medRxiv [Preprint]. 2021 Jul 12:2021.07.08.21259351. doi: 10.1101/2021.07.08.21259351.
PubMed 34268513
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19
- ClinicalTrials.gov ID
- NCT04444700
- Acronym / sponsor ID
- RAPID-BRAZIL / CAAE: 33109220.7.0000.0068
- Conditions
- COVID, Coronavirus Infection, Severe Acute Respiratory Syndrome, Thromboembolism, Venous, Anticoagulants and Bleeding Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Unity Health Toronto, University of Vermont Medical Center
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 23 Jun 2020 (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.
Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients admitted for COVID-19 with an elevated D-dimer.
Detailed description
2-arm, parallel, pragmatic, multi-centre, open-label randomized controlled trial to determine the effect of therapeutic anticoagulation, with low molecular weight heparin or unfractionated heparin (high dose nomogram), compared to standard care in hospitalized patients with COVID-19 and an elevated D-dimer on the composite outcome of intensive care unit (ICU) admission, non-invasive positive pressure ventilation, invasive mechanical ventilation or death at 28 days. Eligible participants will be randomized to one of two treatment regimens, receiving either therapeutic anticoagulation or standard care until discharged from hospital, death or day 28.
The primary composite outcome of ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation, or all-cause death up to 28 days.
Key secondary outcomes between study arms up to day 28 include:
- All-cause death
- Composite outcome of ICU admission or all-cause death
- Composite outcome of mechanical ventilation or all-cause death
- Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation
- Number of participants who received red blood cell transfusion (≥1 unit)
- Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
- Renal replacement therapy;
- Number of hospital-free days alive
- Number of ICU-free days alive
- Number of ventilator-free days alive
- Number of organ support-free days alive
- Number of participants with venous thromboembolism
- Number of participants with arterial thromboembolism
- Number of participants with heparin induced thrombocytopenia
- Changes in D-dimer up to day 3
The treatment arm is therapeutic anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH, high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin, or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to the center-specific protocol. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. The standard care arm is the administration of LMWH, UFH or fondaparinux at thromboprophylactic doses in the absence of contraindication.
No study specific bloodwork will be ordered aside from a single D-dimer test (if not collected through standard of care) up to and including day 3 after randomization for all participants in both study arms. In those on the active treatment arm who are receiving UFH, the aPTT or UFH anti-Xa will be drawn according to local institutional UFH nomogram protocol guidance. All laboratory results will be collected from standard of care from admission to hospital discharge, death or 28 days, where available. An optional biobanking component will collect blood at baseline and 2 follow up time points.
This study will immediately impact the clinical care of patients with severe COVID-19 internationally, whether the findings are positive or negative, as COVID-19 coagulopathy is a highly prevalent complication of severe COVID-19 and may precede the respiratory manifestations that characterize it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a 2-arm, parallel, pragmatic, multi-centre, open-label randomized controlled trial to determine the effect of therapeutic anticoagulation on the composite outcome of ICU admission, mechanical ventilation and/or death in hospitalized patients with COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Drug: Therapeutic anticoagulationTherapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. |
| Standard care | No intervention | –Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Therapeutic anticoagulationThe choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol. | Drug | Therapeutic anticoagulation |
Primary outcome
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Time frame: up to 28 days
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
15 secondary outcomes
All-cause death
Time frame: Up to 28 days
Composite outcome of ICU admission or all-cause death
Time frame: Up to 28 days
Composite outcome of mechanical ventilation or all-cause death
Time frame: Up to 28 days
Major bleeding
Time frame: Up to 28 days
Red blood cell transfusion
Time frame: Up to 28 days
Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipiate and/or fibrinogen concentrate
Time frame: Up to 28 days
Renal replacement therapy
Time frame: Up to 28 days
Hospital-free days alive up to day 28
Time frame: Up to 28 days
ICU-free days alive up to day 28
Time frame: Up to 28 days
Ventilator-free days alive up to day 28
Time frame: Up to 28 days
Organ support-free days alive up to day 28
Time frame: Up to 28 days
Venous thromboembolism
Time frame: Up to 28 days
Arterial thromboembolism
Time frame: Up to 28 days
Heparin induced thrombocytopenia
Time frame: Up to 28 days
Changes in D-dimer up to day 3
Time frame: Up to day 3
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 26 Oct 2021.
- Derived from this study: PubMed 34268513Sholzberg M, Tang GH, Rahhal H, AlHamzah M, Kreuziger LB, Ni Ainle F, Alomran F, Alayed K, Alsheef M, AlSumait F, Pompilio CE, Sperlich C, Tangri S, Tang T, Jaksa P, Suryanarayan D, Almarshoodi M, Castellucci L, James PD, Lillicrap D, Carrier M, Beckett A, Colovos C, Jayakar J, Arsenault MP, Wu C, Doyon K, Andreou ER, Dounaevskaia V, Tseng EK, Lim G, Fralick M, Middeldorp S, Lee AYY, Zuo F, da Costa BR, Thorpe KE, Negri EM, Cushman M, Juni P; RAPID Trial investigators. Heparin for Moderately Ill Patients with Covid-19. medRxiv [Preprint]. 2021 Jul 12:2021.07.08.21259351. doi: 10.1101/2021.07.08.21259351.
- Individual participant dataSharing planned: No
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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.
Peter Juni, MD, FESC principal investigator
St Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto
Elnara M Negri, MD, PhD principal investigator
Laboratório de Investigação Médica da FMUSP
Heraldo P de Souza, MD, PhD principal investigator
Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic anticoagulation in people with COVID and Coronavirus Infection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Oct 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days. (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444700, which also lists 1 linked publication.
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 26 Oct 2021.